185 - ISO 10013, Document Control In Pharma & Devices: SOPs, Work Instructions, And RACI Done Right With Aaron Snyder Let's Combinate

12:38

In this episode of Let's Accommodate Drugs and Devices, host Subhi Saadeh shares four pieces of timeless career advice inspired by Morgan Housel's book, 'Same as Ever'. This episode is particularly aimed at bioengineering students and early-career professionals. The tips include: publishing early to build visibility, understanding how industry regulations and processes work, developing interdisciplinary skills, and finding mentors for guidance. Subhi emphasizes the importance of learning for its own sake and seeking out diverse experiences to enhance one's career prospects in the highly regulated field of bioengineering. 00:00 Introduction and Purpose of the Episode 00:36 Tip 1: Start Publishing Early 04:26 Tip 2: Learn How Industry Really Works 06:14 Tip 3: Build Skills Across Disciplines 09:00 Tip 4: Find Mentors and Network 12:08 Conclusion and Recap Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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185 - ISO 10013, Document Control in Pharma & Devices: SOPs, Work Instructions, and RACI Done Right with Aaron Snyder 25:51

9 days ago25:51

25:51

In this episode of Let's Combinate, host Subhi Saadeh is joined by Aaron Snyder, the creator of Quality Systems Explained and a seasoned consultant in regulated quality systems. The discussion revolves around the critical role of documentation in quality systems, which serves as the backbone of compliance. Key topics include the hierarchy of regulations, document management best practices, the intricacies of quality manuals, and the critical distinctions between SOPs and work instructions. Additionally, they explore the interconnectedness of document control and training, emphasizing the importance of defined roles and responsibilities within organizations. Listeners are provided with insights into establishing and maintaining effective documentation systems while ensuring adherence to regulatory requirements. 00:00 Introduction and Guest Introduction 00:37 The Importance of Documentation in Quality Systems 01:30 Hierarchy and Structure of Documentation 02:44 Standard Operating Procedures (SOPs) vs. Work Instructions 11:22 Document Control and Change Management 15:52 Roles and Responsibilities in Quality Systems 18:20 RACI Matrix and Its Importance 20:47 Common Issues in Documentation and Training 25:25 Conclusion and Where to Find More Information Aaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained 30:37

16 days ago30:37

30:37

In this episode of Let's Combinate , host Subhi Saadeh welcomes back Skip Creveling, a global expert in program management and Six Sigma methodologies. Skip shares his extensive experience helping Fortune 500 companies optimize design processes, reduce risks, and drive innovation—especially in highly regulated industries like medical devices, pharmaceuticals, and aerospace. The discussion explores Skip’s career transition from Eastman Kodak to the medical device sector, the importance of structured program management, phase gate processes, and the balance between going fast and ensuring thorough planning. Skip also delves into the differences between simple and complex projects and the necessity of having tailored project management templates for various project scales. The episode concludes with insights into how to manage risks effectively through tools like project and portfolio FMEAs, and the importance of data-driven decision-making in project execution. Timestamps: 00:00 – Introduction and Guest Welcome 00:19 – Skip's Background and Experience 01:10 – Transition to Medical Devices and Pharma 03:35 – Program and Project Management Insights 06:03 – Phases and Gates in Product Development 08:59 – Challenges and Strategies in Project Management 10:51 – Examples of Project Management in Action 13:28 – Importance of Planning and Risk Management 18:10 – Templates and Tools for Effective Project Management 29:49 – Final Thoughts and Contact Information About the Host: Subhi Saadeh is a Quality Professional and host of Let's Combinate . With a background in Quality, Manufacturing Operations, and R&D, he has worked in large Medical Device and Pharma organizations to support the development and launch of hardware devices, disposable devices, and combination products for vaccines, generics, and biologics. Subhi currently serves as the International Committee Chair for the Combination Products Coalition (CPC), is a member of ASTM Committee E55, and has served on AAMI's Combination Products Committee. For questions, inquiries, or suggestions, please visit letscombinate.com or connect on the show's LinkedIn page.…

Let's Combinate - Drugs + Devices

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183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products 37:11

23 days ago37:11

37:11

Understanding GXPs: Essential Good Practices for Bioengineering ProfessionalsIn this episode of Let's Combinate, host Subhi Saadeh, a seasoned bioengineer with ten years of experience in the pharma and medical device industries, provides an in-depth exploration of good practice guidelines (GXPs). Subhi covers various GXPs including GMP (Good Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), and GDP (Good Distribution Practice), explaining their roles, regulations, and importance in ensuring the safety, efficacy, and quality of medical devices and pharmaceuticals. He discusses how these frameworks integrate to form a comprehensive approach that governs the lifecycle of medical products from preclinical research to post-market surveillance. Additionally, Subhi delves into GAMP (Good Automated Manufacturing Practice) and GVP (Good Pharmacovigilance Practice), emphasizing their significance in maintaining data integrity and patient safety. This extended episode aims to provide early professionals with a robust understanding of these critical regulatory standards and their real-world applications in industry.00:00 Introduction to GXP02:22 Understanding GMP: Good Manufacturing Practice09:21 Exploring GLP: Good Laboratory Practices17:57 Diving into GCP: Good Clinical Practices24:00 Ensuring Quality with GDP: Good Distribution Practices29:32 Overview of GVP and GAMP33:48 Conclusion and Final ThoughtsSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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182 - 7 Powerful Ways to Find Amazing Mentors in Medical Devices and Pharma 18:42

4 weeks ago18:42

18:42

In this episode of Let's Combinate, Subhi Saadeh shares personal insights and seven crucial lessons on finding the right mentors in the pharmaceutical and medical devices sectors. Subhi emphasizes the transformative impact mentors have had on his life and career, breaking down the types of mentors one can have, such as teachers, sponsors, and peer mentors. He provides practical advice on lowering your expectations, focusing on value and repetition, being mentor-able, and leveraging non-traditional forms of mentorship, like books and advanced tools. Subbi concludes that mentorship is about being open, curious, and willing to learn from various sources. 00:00 Introduction: The Power of Mentorship02:06 Lesson 1: Different Types of Mentors05:04 Lesson 2: Lower Your Bar for Mentors07:51 Lesson 3: Focus on Value and Repetition09:37 Lesson 4: Be Mentor-able11:37 Lesson 5: Look Sideways, Not Just Up12:58 Lesson 6: Don't Wait for a Formal Title15:01 Lesson 7: Mentors Can Be Dead16:41 Conclusion: Recap and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.…

Let's Combinate - Drugs + Devices

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181 - Can Ampoule Drug Delivery Systems REVOLUTIONIZE the Industry? 20:14

5 weeks ago20:14

20:14

Discover how ampoule(ampule) drug delivery systems could revolutionize the pharmaceutical industry in this eye-opening video. Learn about the potential impact of this innovative technology on drug administration and patient care.In this episode of 'Let's Combinate Drugs and Devices,' host Subhi Saadeh is joined by Eric Suglalski, Founder and CTO of Archimedic, to discuss the often-overlooked role of ampules in drug delivery. Eric highlights the stability and contamination resistance benefits of ampules, despite the industry's shift towards vials and pre-filled syringes. He elaborates on the time and cost factors that make transitioning to pre-filled syringes challenging for pharmaceutical companies. The discussion also covers Eric's work on the Ampule Filled Syringe (AFS) system, which aims to combine the usability of pre-filled syringes with the stability of ampules. They delve into the historical context of ampules, global usage patterns, and the hurdles faced in implementing ampule-based technologies. Eric invites interested pharma companies to explore potential collaborations with Ampulous.00:00 Introduction and Guest Welcome00:17 The Overlooked Potential of Ampoules02:11 Challenges with Vials and Prefilled Syringes05:01 The Cost and Time Barrier to Prefilled Syringes08:29 Introducing Ampulous: A New Solution10:36 Technical Details of Ampule Filled Syringes14:39 Historical Context and Global Use of Ampoules16:38 Addressing Concerns and Resistance18:01 Human Factors and Usability19:44 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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180 - MIT Leadership Expert Reveals Management Secrets for Scientists! 25:18

6 weeks ago25:18

25:18

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this episode of Let's Combinate, host Subhi Saadeh interviews Gwen Acton, author of Leadership for Scientists and Engineers. Acton, an MIT Ph.D. turned leadership coach, discusses her book's key topics, including effective hiring, delegation, transitioning from individual contributor to team manager, and managing different personalities. They delve into the challenge of balancing technical work and leadership, the importance of defining leadership, and practical tips for delegation. Acton emphasizes that leadership skills can be learned and provides strategies for managing team goals and career development.Amazon: https://www.amazon.com/Leadership-Scientists-Engineers-Transforming-Brilliant-ebook/dp/B0DYWCDVRV?ref_=ast_author_dpBarnes and Noble: https://www.barnesandnoble.com/w/leadership-for-scientists-and-engineers-gwen-acton/1147071445?ean=979899239330900:00 Introduction and Guest Overview01:56 Gwen Acton's Leadership Journey04:30 Defining Leadership08:18 Optimizing Group Output09:30 Challenges in Leadership Transition12:35 Leadership vs. Technical Skills13:05 Transitioning from Technical to Leadership Roles14:18 Challenges of Dual Roles15:42 The Art of Delegation16:53 Motivating Your Team21:21 Balancing Trust and Oversight24:58 Conclusion and Final ThoughtsDr. Gwen Acton is a leadership expert specializing in the biotech and pharmaceutical industries. With a PhD in biology from MIT and years of experience guiding scientists and technical professionals into leadership roles, she helps individuals transition from expert contributors to effective managers. As a sought-after speaker, consultant, and author, Gwen provides practical strategies for navigating the complexities of leadership in highly regulated, innovation-driven environments.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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179 - Quality is NOT Everyone’s Job—Why That’s a GOOD Thing 9:27

7 weeks ago9:27

9:27

In this episode of Let's Combinate, host Subhi Saadeh, a seasoned quality professional, delves into the concept of 'everyone owns quality' and explains why this notion is flawed. Subhi recalls his eye-opening experience with Joanna Gallant's article on quality ownership and discusses the importance of clear accountability within organizations. The episode emphasizes that while all employees play a role in quality, true ownership lies with top management. Subhi also highlights regulatory frameworks like ISO 13485 and 21 CFR 820, noting how they mandate management's responsibility for quality systems. The discussion extends to real-world examples, including the Ranbaxy scandal, to illustrate the dire consequences of poor quality management. The episode concludes with a call to shift the mindset from 'everyone owns quality' to 'leadership owns quality.' 00:00 Introduction to Quality Ownership04:10 Regulatory Frameworks and Quality Management05:14 The Flaws in 'Everyone Owns Quality'06:45 Case Study: Ranbaxy Laboratories08:49 The Importance of a Strong Quality CulturePrevious Episodes:Joanna Gallant: https://www.letscombinate.com/076-gmp-training-competence-human-error-and-mentorship-with-joanna-gallant/Katherine Eban: https://www.letscombinate.com/115-bottle-of-lies-generic-drugs-quality-ranbaxy-audits-and-inspiring-quality-pros-with-nyt-be/Links: ICH Q10: https://database.ich.org/sites/default/files/Q10%20Guideline.pdfISO13485: https://www.iso.org/standard/59752.html21CFR820: https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820/subpart-B/section-820.20BBC Article: https://www.bbc.com/news/world-asia-india-22520953Bottle of Lies: https://www.amazon.com/Bottle-Lies-Inside-Story-Generic/dp/0062338781Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.…

Let's Combinate - Drugs + Devices

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178 - CAPA Face-Off: Pharma vs. MedTech – Key Differences You Need to Know 31:22

8 weeks ago31:22

31:22

In this episode of Let's Combinate, host Subhi Saadeh is joined by quality systems expert Aaron Snyder to explore the critical quality system element known as CAPA (Corrective and Preventive Action). They dive into the differences between CAPA approaches in the pharmaceutical and MedTech industries, examining their historical and regulatory contexts. Aaron explains how U.S. regulations describe deviations on the pharma side and non-conforming products on the MedTech side, and how these are handled differently under respective quality systems. The conversation also touches on topics like root cause analysis, verification of effectiveness, and the importance of management support in making CAPA systems effective. Aaron highlights the value of continuous improvement and debunks common misconceptions about CAPA in both industries. 00:00 Introduction and Guest Introduction 00:33 Understanding CAPA in Pharma and MedTech 01:08 Regulatory Differences and Their Implications 03:12 Event Handling and Investigation Processes 08:13 CAPA System Effectiveness 13:57 Quality System Approaches in Pharma and MedTech 26:22 Root Cause Analysis and Continuous Improvement 30:43 Conclusion and Contact Information Aaron Snyder is a quality management systems expert and the founder of Quality Systems Explained. He previously served as VP of QA at Allotex and has held roles at Fresenius Kabi, Molnlycke, Waters Corporation, Covidien, Cardinal Health, and General Electric. With extensive experience across pharmaceuticals, medical devices, and combination products, Aaron is also a member of the AAMI Faculty, teaching several courses on various QMS topics. An avid content creator, he dissects, presents, and teaches QMS and cGMP topics on his YouTube channel, Quality Systems Explained. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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177 - The GXPs That Run Pharma & Medical Devices: GMP, GDP, GCP, GLP, GVP, GAMP EXPLAINED 10:58

9 weeks ago10:58

10:58

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com 🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. This episode dives into the world of GXPs, the essential guidelines for ensuring quality and safety in pharmaceutical and medical device industries. The host explains various GXPs, including Good Laboratory Practices (GLP), Good Clinical Practices (GCP), Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), Good Pharmacovigilance Practices (GVP), and Good Automated Manufacturing Practices (GAMP). Each GXP covers different stages from preclinical research to post-market safety, ensuring that products are produced safely, effectively, and consistently. The episode emphasizes the importance of understanding these regulations to guarantee the delivery of high-quality products to patients. 00:00 Introduction to GXPs 02:06 Understanding Good Manufacturing Practices (GMP) 03:27 Exploring Good Laboratory Practices (GLP) 04:35 The Importance of Good Clinical Practices (GCP) 05:44 Ensuring Safety with Good Distribution Practices (GDP) 06:55 Monitoring with Good Pharmacovigilance Practices (GVP) 07:48 Good Automated Manufacturing Practices (GAMP) 08:45 How GXPs Work Together 10:45 Conclusion and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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176 - The Fastest Way to Ruin Drug/Device Development (And How to Avoid It!) with Eric Sugalski 26:20

10 weeks ago26:20

26:20

In this episode of Let's Combinate Drugs and Devices, host Subhi Siddhey welcomes Eric Sugalski, founder and CTO of Archimedic. Eric shares insights into the complexities of working as a CDMO, emphasizing the importance of recognizing whether a sponsor company needs overflow capacity or specialized expertise. They discuss common pitfalls, such as companies getting in their own way by misaligning their needs with their outsourcing strategy and the detrimental effects of premature concept lock. Eric highlights the value of giving design firms creative space, the importance of early user research, and the impact of timing and market readiness on project success. He also elaborates on the benefits of open-source quality management systems and hands-on market research to bridge the gap between engineers and users. Together, they explore how to set up projects for success through balanced, well-researched approaches.00:00 Introduction and Guest Welcome00:13 Challenges in Outsourcing for Pharma and Med Device Companies01:04 Importance of Expertise in Outsourcing03:27 Effective Collaboration with CDMOs04:41 Concept Development and Design Requirements05:38 Balancing Innovation and Practicality07:48 Commercialization and Product Development09:57 Understanding User Needs in Design20:47 Advice for Aspiring Engineers25:15 Conclusion and Contact InformationEric Sugalski is the Founder and CTO of Archimedic, a contract design and development organization (CDMO) specializing in drug delivery devices and combination products. With over 25 years of experience in medical device development, he has worked extensively on early-stage concept development, human factors engineering, and commercialization strategies. His work spans life-support systems, remote monitoring technologies, and drug delivery devices, with a focus on balancing technical innovation with market viability. In addition to leading Archimedic, he teaches courses on product development, regulatory strategy, and entrepreneurship at institutions like MIT, the University of Pennsylvania, and West Chester University, helping to bridge the gap between engineering education and industry application.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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175 - Hearing Aid Innovations and Why Hearing Loss Is More Dangerous Than You Think with Bill Facteau 39:49

11 weeks ago39:49

39:49

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this episode of Let's Combinate, host Subhi Saadeh interviews Bill Facteau, President and CEO of Earlens Corporation, who has over three decades of experience in the medical device industry, focusing on hearing innovations. Bill discusses his journey in the ear, nose, and throat field, including his motivation to improve hearing aid technology due to personal experiences and unmet needs in the market. The conversation covers the limitations of traditional air conduction hearing aids, the unique advantages of Earlens' technology, and the broader industry challenges such as lack of education and reimbursement issues. Bill also highlights the critical importance of treating hearing loss to prevent cognitive decline and other health issues. The episode concludes with leadership advice and a discussion on books that have influenced Bill's career. 00:00 Introduction and Guest Welcome 00:42 Bill Facto's Career Journey 03:01 Challenges in Hearing Aid Technology 08:15 Preventing Hearing Loss 12:05 Ear Lens Innovation 33:03 Hearing Loss and Cognitive Health 35:01 Leadership and Personal Insights 39:36 Conclusion and Contact Information Bill Facteau is the President and CEO of Earlens Corp, which is focused on transforming the hearing aid industry with its novel and proprietary light-based technology. Prior to joining Earlens, Mr. Facteau served as President and CEO of Acclarent, the company that created Balloon Sinuplasty, which was ultimately acquired by JNJ for $800M. Mr. Facteau has served as a Board Director on a number of successfully acquired ventures including Acclarent, Neotract, CVI, Cabachon and ExploraMed. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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174 - How GLP-1s Like Ozempic & Wegovy Are Changing Pharma with Ben Locwin 23:57

12 weeks ago23:57

23:57

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. Ben Locwin discusses the science, quality, and future of GLP-1 receptor agonists, revolutionary drugs used in diabetes and obesity treatment. The episode explores the history and development of GLP-1s, their commercial viability, manufacturing challenges, and regulatory landscapes. Ben dives into the mechanisms of GLP-1s, including their influence on appetite, blood sugar, and gastrointestinal effects. They also touch on the capacity issues in production, the impact of compounding, and the sustainability concerns associated with injector pens. The conversation provides an in-depth look at the pharmaceutical industry’s response to the surge in GLP-1 demand, highlighting the broader implications for patient care and market trends.00:00 Introduction to GLP Receptor Agonists00:46 Guest Introduction: Ben Locwin01:48 Historical Context of GLP-1 Development05:54 Mechanisms and Effects of GLP-109:51 Market Impact and Manufacturing Challenges11:16 Regulatory and Advertising Considerations17:44 Sustainability and Injector Pen Issues19:40 Risk Management and Future Directions23:31 ConclusionBen Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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173 - Shelley Amster on 45 Years Trailblazing: IUD’s, Breaking Barriers in IVF & Women's 32:58

13 weeks ago32:58

32:58

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this episode of Let's Combinate, host Subhi Saadeh interviews Shelley Amster, a trailblazer in reproductive health with over 45 years of experience. Shelley shares her journey from being one of the first IVF lab directors in the U.S. to her role as an advisor at 3Daughters. They discuss the early days of IVF, overcoming career-related insecurities, and the challenges and advancements in fertility treatments. Shelley also talks about her experience in managing technical conferences and offers advice for early-career professionals. The conversation covers innovative technologies in women's health, particularly in IUD development and surgical advancements.00:00 Welcome to Let's Combinate00:13 Pioneering in Reproductive Health00:42 Early Challenges and Opportunities02:10 Breaking Barriers in IVF04:52 Career Reflections and Lessons06:40 Conference Planning Insights13:37 Overcoming Shyness and Networking19:11 Retirement and Career Advice26:21 Innovations in Women's Health30:26 Future Technologies and Closing ThoughtsShelley Amster is a trailblazer in reproductive medicine with over 45 years of experience, including being one of the first IVF lab directors in the United States. Currently an advisor at Three Daughters, she has dedicated her career to advancing fertility treatments, IUD development, and surgical innovations in women’s health. Shelley is also a seasoned conference organizer and mentor, sharing invaluable insights with early-career professionals in the field.Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

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172 - Regulatory AI Innovations, Drugs@FDA Database, Regulatory Intelligence Strategies, Human Factors Insights, and Smarter Submission Approaches with Doug Mead 34:19

14 weeks ago34:19

34:19

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letscombinate.com/ Get expert insights on FDA regulations, risk management, quality systems, and the latest trends in drug-device combination products. In this episode of Let's Combinate, host Subhi Sadeh welcomes regulatory expert Doug Mead. Doug, who brings extensive experience in regulatory affairs for medical devices and combination products, discusses the significant role of the 'Drugs at FDA' database in navigating submission strategies. They explore how AI is being used to search through this database efficiently and reveal both the benefits and limitations of AI in regulatory processes. Doug also shares insights into the evolution of FDA’s review processes, the importance of validation, and the practical application of AI in regulatory work.00:00 Welcome and Introduction00:07 Meet Doug Mead: Regulatory Expert00:58 Understanding the Drugs at FDA Database01:25 Navigating Review Memos and Regulatory Strategies04:18 Challenges and Limitations of the FDA Database07:23 Advanced Search Techniques and AI Integration10:58 Developing a Specialized AI Search Tool14:57 Practical Applications and Client Benefits33:22 Conclusion and Contact InformationDouglass(Doug) Mead is Founder of CP Pathways. He's a highly experienced combination products regulatory expert with more than 40 years of experience in large and small pharma and medical device companies. He has a diverse background in regulatory affairs for drugs and devices, including their design and testing, risk analysis, human factors testing, stability testing, and clinical trial real use patient handling assessments.www.cppathways.comSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.Artificial intelligence in Pharma, AI Pharma, AI Medical Devices, Medical Device AI…

Let's Combinate - Drugs + Devices

1
171 - Are Pre-Filled Syringes with Vaccines, Biologics, Generics, or Small Molecules considered Combination Products? 7:59

16 weeks ago7:59

7:59

In this episode of 'Let's Combinate,' host Subhi Saadeh delves into the challenges and complexities of working with prefilled syringes in regulatory, quality, and product development settings. Subhi, who has worked on vaccines, biologics, and small molecules in prefilled syringe systems He explores what makes a prefilled syringe a combination product and explains the varying regulatory requirements across different regions, including the US, EU, China, and Japan. The episode emphasizes the importance of understanding these differences to ensure success in product development and market approval. Saadeh also invites viewers to engage and provide feedback in the comments section.00:00 Introduction to Prefilled Syringes01:54 Understanding Combination Products02:32 Regulatory Frameworks for Prefilled Syringes04:59 Global Regulatory Perspectives06:10 Key Takeaways and ConclusionSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page. Pre-filled Syringes: Are They Really Combination Products? Are They Really Combination Products?,are they really combination products?,Is a PFS a Combination Product,https://youtu.be/eq_IEsBflQE,https://youtu.be/eq_iesbflqe,They Really Combination Products,they really combination products,Are They Really Combination,are they really combination,They Really Combination,they really combination,steph curry,Pre-filled Syringes Are They Really Combination,filled Syringes Are They Really Combination,Pre-filled Syringes Are They Really…

Let's Combinate - Drugs + Devices

1
170 - The #1 Secret to Understanding ISO 13485 (You’ll Wish You Knew Sooner) 9:43

16 weeks ago9:43

9:43

By viewing ISO 13485 through the lens of interconnected Plan-Do-Check-Act (PDCA) cycles, Subhi offers a fresh perspective that simplifies the implementation of this quality management standard. He explains the structure of ISO 13485, highlighting how each clause aligns with PDCA, and provides practical examples of applying this cycle to different processes within the standard. Subhi emphasizes that ISO 13485 is more than a rule book; it's a guide for continuous improvement and real-world application in the medical device field. 00:00 Introduction to Game-Changing ISO 13485 Insight 01:24 Understanding ISO 13485 as a Guide 02:11 ISO 13485 Structure and Clauses 03:56 Plan, Do, Check, Act (PDCA) Cycle Explained 05:44 Applying PDCA to ISO 13485 Clauses 07:33 Real-World Application and Continuous Improvement 09:10 Conclusion and Call to Action Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

1
169 - Should You Study Bioengineering in 2025? My Decade-Long Perspective 16:36

17 weeks ago16:36

16:36

In this episode, Subhi Saadeh, a seasoned professional in the pharma and medical device industry, shares his insights on whether choosing bioengineering is the right career path. Drawing from his 10+ years of experience, Subhi discusses the differences between bioengineering and biomedical engineering, the pros and cons of studying bioengineering, and how to approach this field in 2025. He emphasizes the importance of technical skills, networking, and adapting to a competitive, fast-paced, and evolving industry. Additionally, Subhi provides practical advice for high school and early college students considering this major, highlighting key skills to develop and strategies to stand out in the field.00:00 Is Bioengineering the Right Path for You?00:58 Understanding Bioengineering vs. Biomedical Engineering03:06 My Personal Journey into Bioengineering06:00 The Future of Bioengineering Careers07:48 Pros and Cons of Studying Bioengineering12:32 How to Succeed in Bioengineering in 202515:32 Final Thoughts and AdviceSubhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page. Should You Study Bioengineering in 2025?,should you study bioengineering in 2025?,engineering,university,You Study Bioengineering in 2025,My Decade-Long Perspective,biotech,https://youtu.be/t8mk6TnSo1g,https://youtu.be/t8mk6tnso1g,Should You Study Bioengineering,should you study bioengineering,bioengineering,biomedical engineering,biotechnology,You Study Bioengineering,Is Bioengineering the Right Path for You?,Understanding Bioengineering vs. Biomedical Engineering…

Let's Combinate - Drugs + Devices

1
168 - Audits, Audits, Audits: Why They Matter in Pharma, Medical Devices, and Personal Growth 13:21

18 weeks ago13:21

13:21

In this episode of Let's Combinate, host Subhi Saadeh discusses the significance of audits as a key appraisal activity and draws parallels with personal self-assessment inspired by Peter Drucker's book, 'Managing Oneself.' He emphasizes the value of understanding one's learning style and values in personal development. Subhi delves into the different types of audits, including internal, second-party, and third-party audits, and explains their unique purposes and importance. The episode highlights the relevance of audits in maintaining quality and compliance in the pharma and medical device industries, while also offering best practices for effective audit management. Subhi invites listeners to use audits as a tool for growth, safety, and success. 00:00 Introduction 00:12 'Managing Oneself' by Peter Drucker 00:55 Key Quotes from the Book 03:33 Connecting Audits to Self-Improvement 04:37 Understanding Audits 06:55 Types of Audits 10:27 Best Practices in Auditing 12:03 Conclusion and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

1
167 - Smart Pills, Digital Drug Delivery Systems, and How Technology is Reshaping Pharma and Healthcare with Timothy Aungst 41:13

19 weeks ago41:13

41:13

In this episode of Let's Combinate, host Subhi Saadeh dives into the world of digital transformation in healthcare with Dr. Timothy Aungst, a visionary pharmacist and digital health expert. Dr. Aungst breaks down digital therapeutics, smart drug delivery systems, and wearable technology. He elaborates on the nuances of digitalization, digital transformation, and how these concepts are reshaping the pharmaceutical and healthcare industries. The discussion also touches on the evolving role of pharmacists in a tech-driven healthcare landscape, the impact of AI, and the regulatory challenges in adopting new technologies. 00:00 Introduction to Digital Apothecary with Dr. Timothy Ongst 01:00 Understanding Digital Transformation in Healthcare 03:11 The Evolution of Digital Health and Its Impact 08:23 Future of Healthcare: Expectations and Innovations 13:03 Challenges and Strategies in Pharma's Digital Transformation 20:46 The Role of Digital Tools in Drug Delivery and Adherence 21:19 Challenges of Digital Integration in Healthcare 22:14 Pharmacist's Perspective on Drug Line Therapy 24:04 Clinical and Payer Considerations 25:33 Digital Transformation in Medication Efficacy 30:36 Regulatory Challenges and Bias in Healthcare 36:38 The Role of AI in Digital Health 39:48 Closing Thoughts and Future Outlook Dr. Timothy Aungst is a leading expert in digital health and pharmacy, widely recognized for his work in advancing digital therapeutics, medication adherence technologies, and the integration of health apps into clinical practice. As the voice behind The Digital Apothecary , Dr. Aungst bridges the gap between emerging digital health innovations and the pharmaceutical landscape. His insights provide valuable guidance for healthcare professionals navigating the rapidly evolving intersection of technology and medicine. Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

1
166 - Sync or Sink: 3 Levels of Harmonization for Combination Product Success 20:51

20 weeks ago20:51

20:51

Subhi proposes a broader definition of harmonization, not just aligning regulations but also fostering synergy among drug and device teams. Subhi emphasizes the importance of creating seamless ecosystems for operational harmony, addressing both internal and external collaborations. Additionally, Subhi explores the complexities of regulatory differences between regions, advocate for standardized quality agreements, and stress the significance of relationship management between sponsors and contract organizations (CXOs). The ultimate goal is to achieve regulatory and operational harmony within the combination products space. 00:00 Introduction and Personal Insights 00:28 Defining Harmonization 02:38 Challenges in Regulatory Harmonization 03:43 Operational Harmony and Internal Collaboration 10:38 Sponsor and CXO Harmonization 14:15 Internal Drug and Device Harmonization 17:37 Solutions and Final Thoughts 20:41 Conclusion and Thank You ---------------------------------------- This talk was given at the PharmaED Resources Pre-filled Syringes & Injection Devices 2024 Conference: Exploring the Future of Parenteral Combination Products December 4-5, 2024, La Jolla, CA Note: Apologies for the audio not being of the quality you're used to —this is after hours of post-production. Trust me, the original was worse. 😅…

Let's Combinate - Drugs + Devices

1
165 - Anatomy of a Target Product Profile(TPP): All 10 Sections EXPLAINED with Marta New 1:10:41

21 weeks ago1:10:41

1:10:41

In this episode of Let's Combinate, host Subhi Sadeh is joined by Marta New, CEO of Radyus Research, to discuss the importance of Target Product Profiles (TPPs) in drug development and combination products. Marta, with her unique background as a venture capitalist turned CRO founder, shares her insights on how TPPs serve as strategic documents that align clinical goals, regulatory requirements, and market strategies. The discussion delves into the key sections of a TPP, such as target indication, efficacy benchmarks, safety and toxicology, and regulatory strategy. Marta emphasizes the critical role of TPPs in preclinical stages and their impact on the overall success of drug development programs. The episode also explores the integration and collaboration required across various functions like R&D, quality, regulatory, and commercial teams to create and refine a robust TPP. 00:00 Introduction and Welcome 00:26 Meet Marta: CEO of Radius Research 00:58 Understanding Target Product Profiles (TPPs) 01:44 The Importance of TPPs in Drug Development 01:59 Defining a TPP 03:22 TPP as a Strategic Document 05:28 TPP in Preclinical and Clinical Stages 07:09 Challenges and Misconceptions in TPP Development 14:27 Regulatory Considerations for TPPs 14:53 Sections of a TPP 39:07 Understanding Toxicology Evaluations 39:34 FDA Requirements for Pre-IND Talks 39:51 TPP and Toxicity Thresholds 41:41 Go/No-Go Criteria in TPP 42:50 PKPD and Drug Distribution 45:40 Drug Formulation and Quality Attributes 46:36 Regulatory Strategy and 505(b)(2) Pathway 52:34 Differentiation and Risk Assessment 01:03:42 Transition from Discovery to Development 01:07:48 Combination Products and Delivery Systems 01:09:35 Conclusion and Contact Information Marta New PhD MBA is the CEO of Radyus Research. She is an experienced drug developer with a background in early-stage venture capital, considerable pharma R&D, and university technology transfer. She can be reached at mnew@radyusresearch.com…

Let's Combinate - Drugs + Devices

1
164 - Tiny Particles, Big Impact: Breaking down USP 788 & USP 790 13:15

22 weeks ago13:15

13:15

In this episode, Subhi Saadeh delves into the specifics of USP chapters 788 and 790, which focus on the testing and acceptance criteria for sub-visible and visible particles in injectable drug products. He explains the importance of these standards in preventing health risks such as embolisms and allergic reactions. The episode outlines the methods used for testing, including light obscuration and microscopic particle count tests, as well as the required visual inspections for visible particles. Subhi also discusses the differences in scope between USP and ISO standards and emphasizes the critical role of operator training and clean handling practices in ensuring product safety. 00:00 Introduction to Today's Topic: Particles 00:48 Understanding USP and Its Role 02:52 Diving into USP 788: Sub-Visible Particles 05:40 Testing Methods for Sub-Visible Particles 07:00 Acceptance Criteria for Sub-Visible Particles 08:53 Exploring USP 790: Visible Particles 11:12 Inspection Techniques and Practical Considerations 12:50 Conclusion and Wrap-Up Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

1
163 - ICH Q12, Established Conditions, Post-Approval Changes, PACMP's, and the Pharma Lifecycle 11:19

23 weeks ago11:19

11:19

In this episode of Let's Combinate, host Subhi Saadeh delves into the significance of ICH Q12 for the pharmaceutical industry, especially concerning established conditions and drug-device combination products. Subhi explains how Q12 enhances lifecycle management, streamlines post-approval changes, and improves regulatory alignment. He breaks down critical concepts such as established conditions, product lifecycle management (PLCM), and post-approval change management protocols (PACMPs). Subhi outlines the benefits and challenges of adopting ICH Q12 and encourages listeners to familiarize themselves with its guidelines. 00:00 Introduction and Welcome 00:31 Topic Overview: ICH Q12 and Established Conditions 01:01 Understanding ICH Q12: Life Cycle Management 02:26 Importance of Post Approval Changes 04:11 Key Concepts of ICH Q12 06:14 Practical Example of ICH Q12 Application 07:45 Benefits and Challenges of ICH Q12 10:32 Final Thoughts and Encouragement 11:26 Closing Remarks and Contact Information…

Let's Combinate - Drugs + Devices

1
162 - Philip Crosby’s 5 Bad Beliefs About Quality (And How to Avoid Them) 17:43

24 weeks ago17:43

17:43

In this episode, Subhi delves into 'Quality is Free' by Philip Crosby, a seminal book in quality management. Highlighting its personal significance, the host discusses the core concept that quality, when properly managed, incurs no extra cost, aligning with prevention rather than fixing issues. The episode dissects five erroneous beliefs about quality, including the idea that quality equates to luxury, that it is intangible and immeasurable, and that quality issues stem from workers or are confined to the quality department. Emphasizing a holistic and preventative approach, the discussion reflects on different quality philosophies and the importance of leadership alignment. The episode concludes by encouraging listeners to read the book themselves for a deeper understanding of quality management principles. 00:00 Introduction to 'Quality is Free' 00:24 The Impact of 'Quality is Free' 01:30 Key Concepts: What We Think We Know is All Wrong 02:23 5 Erroneous Beliefs About Quality 06:26 Measuring Quality: Cost and Prevention 09:09 Quality "Responsibility" in Different Departments 15:02 Aligning Leadership and Quality Management 17:05 Conclusion Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.…

Let's Combinate - Drugs + Devices

1
161 - ISO 14971 and ICH Q9 EXPLAINED: Risk Management Frameworks in Medical Devices, Pharma and Combination Products 24:09

25 weeks ago24:09

24:09

In this episode of Let's Combinate, host Subhi Saadeh explores the essential frameworks of risk management in medical devices and pharmaceuticals: ISO 14971 and ICH Q9. He discusses the origins, key elements, similarities, and differences of these standards and guidelines, explaining their application in the development and manufacturing of combination products. Saadeh also highlights the definitions of risk, historical developments, and updates in these frameworks, particularly ICH Q9's recent refinements on managing subjectivity and the formality of risk assessments. The episode compares the structured approach of ISO 14971, focused on patient safety through the entire lifecycle of medical devices, with the broader risk management scope of ICH Q9, which encompasses various elements within the pharmaceutical process. Saadeh provides insights into specialized tools, the concept of state-of-the-art, and the importance of verification of implementation and effectiveness in risk management plans. Listeners from regulatory, quality, product development, and risk management fields will gain a comprehensive understanding of balancing these crucial frameworks for combination products. 00:00 Introduction to Risk Management 00:21 Understanding ISO 14971 and ICH Q9 01:02 Key Elements and Differences 01:35 Deep Dive into ISO 14971 05:08 Deep Dive into ICH Q9 08:53 Comparing Risk Management Tools 14:21 Combination Products and Risk Management 18:34 State-of-the-Art and Residual Risks 21:35 Verification and Effectiveness 22:50 Conclusion and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.…

Let's Combinate - Drugs + Devices

1
160 - Drug Tech Transfer vs. Device Design Transfer EXPLAINED! 19:07

26 weeks ago19:07

19:07

In this episode of *Let's Combinate*, Subhi delves into the critical distinctions between drug tech transfer and device design transfer, especially pertinent to combination products. Sue comprehensively outlines the regulatory frameworks governing each process—ICH Q10 for drug transfer and ISO 13485 for device design transfer. The episode discusses key elements like analytical method transfer and process validation for drugs, and the DHF and risk management in device design. Subhi looks into the differing complexities, regulatory submissions, and validation requirements for both processes. The episode concludes with commercializing combination products, emphasizing project management, regulatory submissions, and post-market surveillance. 00:00 Introduction to Combination Products 00:55 Understanding Drug Tech Transfer 04:04 Exploring Device Design Transfer 08:49 Key Differences Between Drug and Device Transfers 14:30 Commercialization of Combination Products 17:54 Conclusion and Final Thoughts Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.…

Let's Combinate - Drugs + Devices

1
159 - Centralized, Decentralized & Federated Quality Models, McKinsey Study, and QA vs. QC with Ben Locwin 22:24

27 weeks ago22:24

22:24

In this informative episode of Let's Combinate, host Subhi Saadeh and frequent guest Ben delve into the key aspects of quality management across various organizational structures. Through their engaging discussion, they highlight the independence of quality units to prevent conflicts of interest, drawing parallels with finance and HR functions. They examine models like centralized, decentralized, and federated structures, supported by industry benchmarks and practical experiences. The conversation emphasizes the necessity of centralized ownership for consistent quality outcomes, despite quality being everyone's responsibility. Additionally, they explore the nuances within pharmaceutical companies, referencing a McKinsey study that underscores the importance of cultural and procedural elements over structural setup. Distinctions between Quality Assurance and Quality Control are clarified, focusing on the need for proactivity and integration for optimal results. This episode provides comprehensive insights into the structural, cultural, and procedural dimensions of effective quality management. 00:00 Introduction and Guest Welcome 00:19 Questioning the Quality Unit's Independence 01:19 Avoiding Conflicts of Interest in Quality 03:39 Organizational Structures and Quality 09:09 Centralized, Decentralized, and Federated Quality Models 12:06 Understanding Quality Reactivity 12:20 Insights from the McKinsey Study 13:36 The Importance of Quality Culture 14:23 Identifying Problematic Structures 15:19 Designing Non-Reactive Quality Systems 17:13 Quality Management System (QMS) Structures 19:05 QA vs. QC: Key Differences 22:07 Conclusion and Final Thoughts Ben Locwin is a Healthcare Executive, MMA fighter, Jiu Jtisu pro and Quality and Regulatory SME working in medical devices, pharma and other regulated industries.…

Let's Combinate - Drugs + Devices

1
158 - 3 Years Straight of Drug/Device Podcasting, Guarding the Process, and the Future of the Show 21:23

28 weeks ago21:23

21:23

In this episode, host Subhi reflects on three years of podcasting, drawing analogies to strength training and discussing the incremental progress achieved. The episode highlights the importance of consistency in podcast production, inspired by Robert Greene's 'Mastery,' and outlines plans for the show's future evolution. 00:00 Welcome and Podcast Journey 00:39 Strength Training Analogy 02:10 Reflecting on Three Years 04:11 Significant Life Update 05:46 Lessons Learned and Trusting Others 07:37 Podcasting Process and Scheduling 10:34 The Challenges of Editing 11:21 Finding the Right Tools 12:11 Promotion and Growth 12:56 Consistency and Sustainability 13:07 Starting a Podcast: Advice and Reflections 15:52 The Future of the Show 20:12 Engaging with Listeners 21:12 Final Thoughts and Farewell Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.…

Let's Combinate - Drugs + Devices

1
157 - Design Inputs that Don't Suck, Risk Control Measures and Problems with Verification with Chuck Ventura 21:30

29 weeks ago21:30

21:30

In this episode of the Combinate Podcast, host Subhi Saadeh welcomes back Chuck Ventura, founder of Ventura Solutions, to discuss the often overlooked topic of design inputs in product development. Chuck highlights how poor design inputs can slow down product development and lead to issues in market compliance. He stresses the importance of spending adequate time on creating design inputs and the benefits of concurrent engineering to refine specifications. The discussion also covers the relationship between design inputs and risk controls, and Chuck introduces his Design Input Essentials course aimed at helping companies accelerate product development. 00:00 Welcome to the Comedy Podcast 00:04 Introducing Chuck Ventura 00:29 The Importance of Design Inputs 02:07 Challenges with Design Inputs 03:07 Impact on Product Development 04:18 Common Pitfalls in Design Inputs 06:15 Design Verification Issues 10:22 Best Practices for Design Inputs 14:11 Link Between Design Inputs and Risk Controls 18:45 Chuck Ventura's Design Input Course 20:31 Closing Remarks Charles Ventura is the Founder of Ventura Solutions and CEO of HemoTek. Chuck is a leader in the Medical Device & Combination Products space with successful experience in Commercialization, R&D, Project Management, and Manufacturing Support. https://ventura-solutions.com/…

Let's Combinate - Drugs + Devices

1
156 - Combination Product Governance, Big Pharma to Medical Device Startups, Risk Management, Scale Up Challenges, Drug Delivery Innovations, and Home Administration with Laxman Halleppanavar 33:01

30 weeks ago33:01

33:01

On this episode, I was joined by Laxman Halleppanavar, Head of Portfolio Strategy and Management at Credence MedSystems, Inc. On this episode, Laxman, highlights the differences in regulatory oversight and risk management between medical devices and pharmaceuticals, the trend towards home administration of drugs, sustainability goals, and the challenges posed by longer-acting drugs, higher viscosities, and large injection volumes. Laxman also discusses his transition from large corporations to startups and the multifaceted nature of scaling up projects. 00:00 Introduction to the Combinate Podcast 00:56 Understanding the Intersection of Medical and Pharmaceutical Industries 02:56 Challenges in Medical Devices and Pharmaceuticals 03:22 Governance and Risk Management in Healthcare 08:13 Transitioning from Big Pharma to Startups 15:46 Trends in Injection Delivery Systems 28:38 Challenges in Home Administration and Sustainability 31:07 Scaling Up in the Pharmaceutical Industry 32:47 Conclusion and Contact Information Laxman Halleppanavar is currently the Head of Portfolio Strategy and Management at Credence MedSystems, leading the Injectable Device Portfolio Strategy and Management team for internal and external customer endeavors. Previously, Mr Halleppanavar was the Director - PharmSci Technical Team Lead at Pfizer. He came to Pfizer upon its acquisition of Hospira where Mr Halleppanavar was responsible for combination product development from early-stage development to manufacturing scale up leading to commercial launch. Prior to Pfizer, Mr Halleppanavar was the Program Manager at GE Healthcare responsible for development, manufacturing, and commercialization of multiple medical device/patient monitoring platforms namely, patient worn devices, blood pressure cuffs, bedside monitoring devices, networked central & remote monitoring stations.…

Let's Combinate - Drugs + Devices

1
155 - FDA Compliance Programs, Program 7536.000: CDER vs. CDRH led Inspections, Mock PAI's, Supplier Management, and What is a Manufacturer? with Laurie Auerbach 25:25

31 weeks ago25:25

25:25

On this episode, I was joined by Laurie Auerbach, President and Principal Consultant, Compliance Prodigies, LLC. In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program. Laurie discusses the definitions, scope, and expectations of combination product manufacturers, addressing the FDA's inspection types, regulatory requirements, and expectations. Laurie also highlights common misconceptions, especially among contract manufacturers (CMOs) and the importance of proper audit and supplier management practices. Laurie shares insights and practical advice for ensuring compliance, emphasizing the gaps between drug and device regulations and how to effectively bridge them. Chapters: 00:56 Understanding FDA Compliance Programs 02:33 Types of FDA Inspections 03:04 Mock Audits and Process Validation 03:45 Combination Product Manufacturer Definition 04:38 Inspection Guides and Compliance 06:47 Supplier Controls and Responsibilities 09:20 Challenges in Mock Pre-Approval Inspections 16:32 Supplier Management and Quality Agreements 24:19 Contract Manufacturers and Design Control 25:03 Conclusion Laurie Auerbach is an industry consultant with over 20 years of experience in quality and regulatory compliance, serving in management and consulting roles for startup to major global manufacturers in the medical device, in vitro diagnostic, and combination product industries. Laurie conducts internal and supplier audits and mock pre-approval and post-approval inspections for compliance with ISO 13485, ISO 14971, §820, and §4, and EU MDD, IVDD, and EU MDR. She also conducts training for biopharmaceutical sponsors and device platform manufacturers on combination product regulatory requirements, including focused training on design control, risk management, CAPA, supplier controls, and inspection readiness. Laurie serves as Vice Chair of the ISPE Combination Products Community of Practice and is an active member of PDA, AAMI, RAPS, TOPRA, and DIA.…

Let's Combinate - Drugs + Devices

1
154 - IVD's, LDT's, Companion Diagnostics, Precision Medicine, Clinical Validation, Biomarkers, Test Methods, Detection Limits and CLIA with Devon C. Campbell 37:31

32 weeks ago37:31

37:31

On this episode, I was joined by Devon Campbell, Founder and Managing Director of Prodct. Devon covers the differences between IVDs, companion diagnostics, and precision medicine, the risk management aspects specific to IVDs, and the design, verification, and validation processes involved. Devin shares his extensive experience in both big pharma environments and startups, shedding light on the significant time and resource investments required for successful IVD development. ---------------------------------- Chapters: Exploring In Vitro Diagnostics with Devin Campbell In this episode of the Combinate Podcast, host Subhi Siddek welcomes back Devin Campbell, founder and managing director of Product Know You, to discuss in vitro diagnostics (IVDs). They delve into various aspects of IVD development, including the clinical implications, risk management, and distinctions between companion diagnostics and precision medicine. They also cover regulatory pathways, lab-developed tests, and the rigorous validation processes involved. The conversation aims to demystify the complexities of IVDs for professionals in pharma and medical devices. -------------------------------------- 00:00 Introduction 01:58 Understanding In Vitro Diagnostics (IVDs) 05:26 Companion Diagnostics and Precision Medicine 08:49 Lab Developed Tests (LDTs) 12:39 IVD Development Process 15:27 Risk Management in IVDs 20:17 Clinical Testing and Validation 29:12 Challenges and Considerations in IVDs 37:04 Conclusion and Contact Information Devon Campbell is the Founder, Prodct LLC and Chief Product Officer(CPO), myBiometry. He's launched and exited several MedTech ventures and has worked in large Pharma and large IVD companies in executive roles focusing on engineering and product development. https://www.devonccampbell.com/…

Let's Combinate - Drugs + Devices

1
153 - USP 382, Elastomeric Component Functional Suitability, Delivery Systems, Spikes, IV Bags and Alternate Packaging with Fran Degrazio 21:56

33 weeks ago21:56

21:56

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran explores the transition from USP 381 to 382, focusing on stoppers and elastomeric closures. Fran explains the importance of evaluating packaging components as a system and the impact of sterilization processes on functionality. Fran also discusses the scope of USP 382, covering vials, syringes, pens, IV bags, and blow-fill-seal containers, emphasizing the need for harmonization with ISO standards. The episode highlights the necessity for pharmaceutical sponsors to generate data on the system to comply with USP 382 and prepare for its 2025 implementation. 00:00 Introduction to the Combinate Podcast 01:08 Understanding USP 382 and Its Importance 01:41 Differences Between USP 381 and USP 382 03:50 Challenges and Responsibilities in Compliance 07:49 Impact of Sterilization on Stoppers 11:11 Upcoming Changes and Industry Adaptation 15:21 Functional Performance Tests and System Understanding 19:04 Broader Scope: IV Bags and Alternative Packaging 21:33 Conclusion and Contact Information Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals. She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products. Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas. DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018. Frankly Fran Newsletter: https://www.drugdeliveryleader.com/doc/setting-the-bar-for-drug-product-quality-part-the-evolving-practice-of-particle-testing-0001…

Let's Combinate - Drugs + Devices

1
152 - Global Medical Device Podcast Interview: Behind the Combinate Podcast, Combination Products Why, Unique Episodes, Pyramids and Books with Etienne Nichols & Subhi Saadeh 40:48

34 weeks ago40:48

40:48

This episode is a cross-post of an interview I did with Etienne Nichols over at the Global Medical Device Podcast at GreenLight Guru (Episode #380) . In this episode, Etienne and I discuss: 02:50 The Start of the Combinate Podcast 06:00 Efficiency and Tools in Podcast Production 08:40 Understanding Combination Products 09:43 Regulatory Frameworks and Definitions 13:46 Challenges and Misconceptions in the Industry 20:47 Evolution of Regulations: QMSR and Part 4 22:05 Exploring Unique Podcast Episodes 25:56 The Pyramid of Regulations 30:40 The Role of Coaching and Mentorship 32:59 Trends in Combination Products 35:23 Recommended Books and Final Thoughts 37:04 Encouragement for Lifelong Learning Subhi Saadeh is a Quality Professional and host of the Combinate Podcast. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee. Etienne Nichols is a Medical Device Guru and Mechanical Engineer who loves learning and teaching how systems work together. He has both manufacturing and product development experience, even aiding in the development of combination drug-delivery devices, from startup to Fortune 500 companies and holds a Project Management Professional (PMP) certification. Having managed cross-functional teams to update designs of legacy products, Etienne understands the pain of following the Design Controls process in paper-based QMS environment. His expansive knowledge, experience, and passion with medical devices is evenly matched with how much he enjoys helping customers work efficiently through the design and development process to bring safe, high quality products to market…

Let's Combinate - Drugs + Devices

1
151 - Primary Packaging/Container Closure Change Guidance, Post-Approval Changes, Sponsor/Supplier Relationships, Purchasing Controls and Tubular vs. Molded Glass with Fran Degrazio 33:38

35 weeks ago33:38

33:38

On this episode, I was joined by Fran Degrazio, President & Principal Consultant at Strategic Parenteral Solutions and Executive Editor at Drug Delivery Leader. On this episode, Fran discusses: 00:00 Introduction 02:29 Understanding the FDA's New Guidance: 05:05 Challenges in Supplier Management and the 08:22 Navigating Change Management 11:43 Insights on Regulatory Compliance 25:26 The Importance of Dimensional Tolerances 32:56 Closing Thoughts Fran DeGrazio is President & Principal Consultant at Strategic Parenteral Solutions and the former Chief Scientific Officer at West Pharmaceuticals. She has been in the pharmaceutical packaging industry for over 35 years with extensive expertise in the area of delivery of injectable drug products, such as vial/closure combinations, pre-fillable syringe systems, and injectable combination products. Throughout her tenure at West, DeGrazio has served in various functions within the analytical laboratory, research and development, and quality assurance/regulatory areas. DeGrazio is an active member of the PDA PMF Visible Particulate Task Force leadership team and the IPAC-RS Materials Working Group. She has also received the Healthcare Business Woman’s Association Luminary Award for West Pharmaceutical Services in 2017 and the Philadelphia Business Journal Healthcare Innovators Award in 2018. Frankly Fran Newsletter: https://www.drugdeliveryleader.com/doc/setting-the-bar-for-drug-product-quality-part-the-evolving-practice-of-particle-testing-0001…

Let's Combinate - Drugs + Devices

1
150 - Ocular/Ophthalmic Drug Delivery, Intravitreal Administration, Glaucoma, WetAMD, Vision, Range and Presence with Maysaa Attar 38:58

36 weeks ago38:58

38:58

On this episode, I was joined by Maysaa Attar, Senior Vice President of R&D at Bausch + Lomb. On this episode, Maysaa discusses: 00:00 Welcome to Episode 150! 03:00 Challenges and Innovations in Ocular Drug Delivery 09:30 Understanding Intravitreal Injections 13:26 Regulatory Considerations for Ocular Products 20:48 Innovations in Glaucoma Treatment 29:18 The Personal Impact of Vision Loss 35:40 Book Recommendations and Final Thoughts Maysaa Attar is the Senior Vice President of R&D at Bausch & Lomb, leading global pharmaceutical and consumer product research and development. She has held prominent leadership positions at Abbvie and Allergan and holds a PhD in Pharmaceutical Sciences from the University of Southern California (USC), where she also serves as a professor.…

Let's Combinate - Drugs + Devices

1
149 - Lyophilization/Freeze-Drying Equipment, Environment, Cleaning, Loading, Automation, Refrigeration, Vacuum, Filtration, and Potent/Non-Aqueous Considerations with David Simoens 33:11

37 weeks ago33:11

33:11

On this episode, I was joined by David Simeons, Founder of Life Science Professionals and an expert in Lyophilization/Freeze-Drying. On this episode David discusses: 01:01 Recap of the Last Episode 01:23 Understanding the Freeze Drying Environment 01:46 Freeze Drying Equipment and Processes 03:01 Cleaning and Validation in Freeze Drying 03:58 Loading and Automation in Freeze Drying 06:27 Detailed Breakdown of Freeze Drying Components 15:24 Refrigeration and Temperature Control 17:25 Vacuum Systems and Filter Racks 20:18 Challenges in Freeze Drying and Validation 28:08 Advanced Freeze Drying Considerations 31:38 Conclusion and Contact Information David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin ⁠⁠here⁠⁠ or at David@lifescienceprofessionals.com **About David Simoens:** David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector. **Key Specializations:** - Aseptic Fill/Finish including Lyophilization - New Product Introductions - Cytotoxic and High Potency Environments - Integrated Commissioning, Qualification, Validation - Radiopharmaceuticals - Business growth and optimization - Enterprise Quality Management Systems - Career coaching **Contact Information:** For all business inquiries, please reach out to David and his team at contact@lifescienceprofessionals.com. For information requests, email them at info@lifescienceprofessionals.com. Feel free to connect and message him on LinkedIn.…

Let's Combinate - Drugs + Devices

1
148 - Standards Applicability Assessments, Atomic Requirements, Documentation and Timing with Leo Eisner 26:20

38 weeks ago26:20

26:20

On this episode, I was joined by Leo Eisner "IEC 60601 Guy", Founder of Eisner Safety Consultants. On this episode, Leo discusses the complexities involved in assessing the applicability of standards to medical devices and combination products. Leo delves into the importance of understanding product environment, intended use, and market specifics. Leo highlights the challenges and strategies for documenting standards assessments and emphasizes the importance of leveraging existing standards to avoid unnecessary development. The episode also covers tips for small and large companies, the significance of early research, and the essential stakeholders involved in standards assessment. Chapters: 00:00 Introduction to the Combinate Podcast 01:03 Guest Introduction: Leo Eisner 01:19 Understanding Standards Applicability 07:45 Documenting Standards Assessments 12:03 Challenges and Best Practices 20:56 Final Thoughts and Contact Information Leo Eisner, founder and principal compliance and regulatory consultant of Eisner Safety Consultants (ESC), ESC provides the medical device industry with product safety compliance & regulatory support. Leo ensures his clients’ medical device compliance needs are met, provides his clients with practical assessments of their products and provides strategies & support to help them through the medical device product compliance maze based on his experience. He has over 30 years of invaluable experience in the medical device industry. He worked at 3 notified bodies, and his career has spanned over 35 years of product safety certification test lab experience. He worked at 2 internationally recognized labs for 11 years. As an expert in the standards development process, Leo has been staying at the forefront of evolving medical device standards for over 20 years with standards such as the IEC 60601 series, ISO 15223, ISO 20417. Links: Website: https://eisnersafety.com/ Blog: https://eisnersafety.com/industry_news/ & Sign-up for newsletter on right side of page (1/2 way down) LinkedIn: linkedin.com/in/leoeisnersafetyconsultants Contact Us: https://eisnersafety.com/contact_eisner_safety/ Schedule a call: https://eisnersafety.com/schedule-call/…

Let's Combinate - Drugs + Devices

1
147 - URRA Draft Guidance, uFMEA's, Design Validation, HF Summative, Comparative Analysis, Threshold Analysis and Compelling Technical Arguments with David Grosse-Wentrup 23:15

39 weeks ago23:15

23:15

On this episode, I was joined by David Grosse-Wentrup, Research Director for Human Factors at Design Science Group. David walks through: David Grosse-Wentrup PhD is a Research Director at Design Science , a global human factors consultancy focused on advancing healthcare technology through user research and design evaluation. After his studies in biomedical engineering and postgraduate research at the University of Muenster, Germany, as well as work for the Centre for Global eHealth Innovation (Toronto) and GE Healthcare (Wuxi, China), he joined Design Science’s U.S. office in 2016. At Design Science, David supports clients in developing and approving medical devices and combination products for the U.S and E.U. markets. He currently is leading efforts to open Design Science’s first European office in Munich, Germany. He completed his PhD at the University of Münster in 2024.…

Let's Combinate - Drugs + Devices

1
146 - Lyophilization/Freeze-Drying, Filling, Sublimation, Disorption, Backfilling, Stoppers, Vacuum and Water's Triple Point with David Simoens 35:58

40 weeks ago35:58

35:58

On this episode, I was joined by David Simoens, Founder of Life Science Professionals Inc. David walks through the freeze drying(lyo) process, primary drying via sublimation, secondary drying through desorption, and final steps such as backfilling and stoppering. David also explores the different considerations for lyophilization, the impact of various drugs on the process, types of stoppers, and differences between lyophilized and liquid-filled vials. David shares insights on the technical aspects, including pressure, temperature, and time management, as well as equipment considerations and challenges in the lyophilization cycle. 00:00 Introduction and Guest Introduction 01:21 Podcast Overview and Purpose 02:12 Importance of Lyophilization 03:04 Lyophilization Process Explained 04:35 Vial Filling and Stoppering Differences 09:44 Freeze Drying Process 15:45 Primary and Secondary Drying 16:56 Backfilling and Final Steps 30:20 Equipment and Technology 34:41 Conclusion and Guest Contact Information David Simoens is a certified Project Management Professional with over a decade of project management, engineering, and validation experience. David has a strong, professional background in aseptic fill/finish, lyophilization, cytotoxic and high potency, process development, radiopharmaceuticals and enterprise quality management systems. Mr. Simoens assisted in C&Q standardization and implementation on a global level guided by ASTM E2500 and assisted in development of content for the ISPE Baseline Volume 5 guide. He led an effort to assess, pilot, implement and go-live with an electronic engineering platform for several global sites. David has designed, installed, and tested several commercial size Freeze-Dryers and Automated Loading Systems. He managed a month shutdown for one of the largest products on market. David has led high profile NPI launches for a large pharmaceutical company. Currently, he is supporting a team responsible for delivering a complex formulation system and leading strategy/operations for a midsized consulting company. David can be reached on linkedin ⁠here⁠ or at David@lifescienceprofessionals.com **About David Simoens:** David Simoens is a dedicated Project Management Professional with a proven track record in the pharmaceutical industry. In October 2023, he made the pivotal decision to transition from a C-Suite role at a consulting firm to embark on an entrepreneurial journey. David takes pride in being the founder of Life Science Professionals, LLC; a consulting firm committed to excellence in project management, engineering, and quality within the life sciences sector. **Key Specializations:** - Aseptic Fill/Finish including Lyophilization - New Product Introductions - Cytotoxic and High Potency Environments - Integrated Commissioning, Qualification, Validation - Radiopharmaceuticals - Business growth and optimization - Enterprise Quality Management Systems - Career coaching **Contact Information:** For all business inquiries, please reach out to David and his team at contact@lifescienceprofessionals.com. For information requests, email them at info@lifescienceprofessionals.com. Feel free to connect and message him on LinkedIn.…

Let's Combinate - Drugs + Devices

1
145 - Regulatory Policy, Advocacy, Legislation, Combination Product Regulatory Harmonization, IMDRF and Ikigai with Ryan Hoshi 40:28

41 weeks ago40:28

40:28

On this episode, I was joined by Ryan Hoshi, Director of Regulatory Policy and Intelligence at AbbVie. Ryan discusses: 01:18 Understanding Regulatory Policy 03:18 Ryan's Career Journey 05:08 Challenges in Regulatory Harmonization 06:54 Legislative Frameworks and Regulatory Differences Globally 11:10 FDA's Role and Recent Legislation (User Fee reauthorization and the Food and Drug Omnibus Reform Act) 15:51 International Harmonization Efforts 22:36 Combination Products and Policy Work 30:10 The Importance of Advocacy and Education 35:22 Closing Thoughts and Personal Insights Ryan's Article: https://ispe.org/pharmaceutical-engineering/ispeak/chinas-regulatory-framework-combination-products-ongoing Ryan Hoshi is Director of Regulatory Policy & Intelligence and serves as the global policy topic lead for digital health, artificial intelligence, medical devices, combination products, personalized medicine, clinical pharmacology, and cell and gene therapies. Prior to AbbVie, Ryan served as an international policy analyst at the Center for Devices and Radiological Health (CDRH) in the Office of the Center Director and promoted international regulatory harmonization activities through the Asia Pacific Economic Cooperation Regulatory Harmonization Steering Committee, Medical Device Single Audit Program, and International Medical Device Regulators Forum. Ryan also worked on drug policy at the Center for Drug Evaluation and Research (CDER) and as a Lead Reviewer in CDRH on interventional cardiology devices and drug-eluting stents. Ryan earned his bachelor’s degree in Bioengineering from the University of California, Berkeley, his doctorate and master’s degrees in Biomedical Engineering from Northwestern University, and his MBA from Georgetown University, McDonough School of Business.…

Let's Combinate - Drugs + Devices

1
144 - Auto-Injectors, Pen Injectors, Challenges in Product Development, Sponsors and CDMO's with David DeSalvo 35:36

42 weeks ago35:36

35:36

On this episode, I was joined by David DeSalvo, Vice-President of Combination Product Development at Kindeva Drug Delivery. David and I discuss: 00:00 Introduction and Guest Overview 00:04 David DeSalvo's Career Journey 02:13 Understanding Injection Systems 04:22 Early Career at BD 10:51 Transition to SHL 17:50 Starting a New Venture 24:54 Experience at Emergent BioSolutions 29:40 Current Role at Kindeva 32:56 Book Recommendation and Conclusion David DeSalvo is the Vice-President of Combination Product Development at ⁠Kindeva Drug Delivery⁠. He is an expert in drug delivery devices (combination products) and has invented, designed, developed and launched multiple devices. His work has resulted in dozens of highly successful unique drug-device combination products, including many industry-first innovations. https://www.daviddesalvo.com/…

Let's Combinate - Drugs + Devices

1
143 - New FDA Draft Guidance: Essential Drug Design Outputs with Alan Stevens and Rumi Young 29:22

43 weeks ago29:22

29:22

On this episode, I was joined by Alan Stevens and Rumi Young who walk through the contents of the FDA Draft Essential Drug Delivery Outputs for Devices Intended toDeliver Drugs and Biological Products Guidance for Industry. Industry Comments are DUE 9/29/2024. Alan Stevens is the Global Head of Complex Devices and Drug Delivery Systems at AbbVie within the RA Emerging Technologies, Devices and Combination Products team. Prior to joining AbbVie, Alan spent 20 years at the FDA/CDRH leading premarket review and policy development for drug delivery devices and combination products. Rumi Young, Meng, RAC is the Director of Regulatory Policy at Novo Nordisk. Rumi joined Industry from FDA where she spent four years in CDRH’s Division of Drug Delivery, General Hospital and Human Factors. As Acting Assistant Director for Injection Devices, her team was responsible for the approval of drug delivery injection devices and combination products such as syringes, auto injectors, pen injectors, on-body injectors and smart connected devices. Prior to FDA Rumi worked at Genentech and AstraZeneca for eight years in combination product development. Rumi has both a Bachelors in Chemistry and Chemical Biology and Masters in Engineering in Material Science from Cornell University.…

Let's Combinate - Drugs + Devices

1
142 - Material Qualification in Drugs vs. Devices, PPAP, APQP, Quality Tools and Purchasing Controls with Ben Locwin 30:26

44 weeks ago30:26