137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens

Let's Combinate - Drugs + Devices

#Science #Biology #Subhi Saadeh

39:50

The truth is out West! We’re hopping on the ET Highway and venturing to the most notorious alien hot spots, including Roswell’s infamous crash site, Area 51’s eerie perimeter, and a mysterious desert watchtower. Join us as journalist Laura Krantz, host of the podcast Wild Thing , beams up to share stories from the front lines of UFO reporting—from strange sightings and quirky festivals to a mailbox where people leave letters to extraterrestrials. Maybe you’ll even decide for yourself: Is Earth a tourist stop for spaceships? UFO hot spots you’ll encounter in this episode: - UFO Watchtower (near Great Sand Dunes National Park, Colorado) - Roswell, New Mexico - Area 51, Nevada - Extraterrestrial Highway (aka State Route 375), Nevada - Little A’Le’Inn, ET Highway, Nevada - E.T. Fresh Jerky, ET Highway, Nevada - Alien Research Center, ET Highway, Nevada - The Black Mailbox, ET Highway, Nevada Via Podcast is a production of AAA Mountain West Group .…

about a year ago 18:11

MP3•Episode home

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through:

00:38 Exploring Reliability in Combination Products

01:17 The Importance of Subscribing and Feedback

01:36 Alan Stevens Shares His Expertise

02:40 Understanding Reliability: Definitions and Nuances

03:46 Component vs. System Reliability in Device Design

08:55 From FDA Reviews to Industry Insights

11:29 Fault Tree Analysis and Risk Management

14:17 Setting Reliability Expectations for Combination Products

15:32 Navigating Risk Culture and Acceptable Levels of Risk

Alan 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.

193 episodes

137 - The 3 Levels of Reliability, Fault Tree Analysis, Needle Safety, Emergency Use, and Risk Management with Capt. Alan Stevens

Let's Combinate - Drugs + Devices

published about a year ago

MP3•Episode home

On this episode I was joined by Captain Alan Stevens, Global Head of Complex Devices and Drug Delivery Systems at AbbVie. In this episode, Alan walks through:

00:38 Exploring Reliability in Combination Products

01:17 The Importance of Subscribing and Feedback

01:36 Alan Stevens Shares His Expertise

02:40 Understanding Reliability: Definitions and Nuances

03:46 Component vs. System Reliability in Device Design

08:55 From FDA Reviews to Industry Insights

11:29 Fault Tree Analysis and Risk Management

14:17 Setting Reliability Expectations for Combination Products

15:32 Navigating Risk Culture and Acceptable Levels of Risk

193 episodes

#Science #Biology #Subhi Saadeh

All episodes

Let's Combinate - Drugs + Devices

1
190 - Harmony, Not Sameness: What Drug-Device Teams Keep Getting Wrong 15:17

4 days ago15:17

15:17

Episode is based on a talk Subhi Saadeh gave at CPHI. In this episode, Subhi Saadeh breaks down the three levels where true harmonization must happen for drug-device products to succeed:-Global regulatory alignment-Effective sponsor-CXO collaboration-Cross-functional teamwork between drug and device stakeholders inside companiesSubhi covers why regulatory misalignments across countries create uncertainty, how disconnected sponsor-CXO relationships lead to delays and inefficiencies, and how internal friction between pharma and device functions can stall programs even when the science is sound.Timestamps:00:00 – Introduction: The Reality of Drug-Device Combination Products00:39 – Identifying the Core Issues in Combination Product Development01:38 – What Are Drug-Device Combination Products?02:05 – Common Types of Combination Products05:00 – Market Growth & Regulatory Landscape07:26 – Challenges and Silos That Slow Progress10:01 – Practical Strategies for Harmonization and Collaboration14:56 – Final Thoughts: Why Harmony Beats SamenessSubhi 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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189 - FDA, ISO, ICH, USP, PDA - What Are These Groups and Why Do They Matter? 17:14

11 days ago17:14

17:14

Ever wondered who’s really behind the regulations you follow in pharma and medical devices? In this episode of Let’s ComBinate, Subhi Saadeh breaks down the five categories of organizations that influence how we develop, test, and release products:Regulatory Authorities (like FDA, EMA, PMDA)Harmonization Bodies (like ICH, IMDRF, and PIC/S)Standards Organizations (ISO, ASTM, etc.)Pharmacopoeias (USP, JP, Ph. Eur.)Industry Groups (like PDA, MDIC, PhRMA, and more)Subhi dives into how each type contributes to the rules, expectations, and gray areas that define your work — and how to figure out which ones really matter when you're reviewing SOPs, guidance docs, and regulatory submissions.00:00 – Intro01:23 – Regulatory Bodies04:03 – Harmonization Organizations10:01 – Standards Organizations12:07 – Pharmacopoeias13:59 – Industry Groups16:11 – Wrap-up and TakeawaysSubhi 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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188 – Certified Quality Auditor(CQA) and Audits in the Future 15:39

18 days ago15:39

15:39

In this episode of Let’s Combinate, Subhi Saadeh—an ISO 13485 certified lead auditor, CQA, and CQE—dives into the evolving role of auditing in the medical device and pharmaceutical industries. He reflects on his journey to becoming a Certified Quality Auditor and asks a timely question: in the age of AI, will audits—and auditors—still matter? Subhi outlines what separates good auditors from great ones, shares lessons from his own audit experiences, and breaks down how AI might streamline parts of the audit process. But he makes a clear case: while AI can assist, it can’t replace the critical thinking, real-time risk judgment, and systems awareness that human auditors bring. The episode wraps with practical advice on how to embrace AI as a tool—without losing the edge that only people have. 00:00 Introduction to Auditing and Certification 00:43 My Auditing Journey and Experience 02:40 The Importance of Technique in Auditing 03:26 Real-World Auditing Insights 04:59 The Value of Certification 07:16 Key Qualities of a Great Auditor 10:48 The Role of AI in Auditing 12:18 Why AI Won't Replace Human Auditors 15:26 Conclusion and Future Outlook 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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187 - Why Drug and Device Development Use Different Playbooks (QbD vs. Design Controls Explained) 16:26

25 days ago16:26

16:26

What’s the difference between Quality by Design (QbD) and Design Controls—and why should you care if you're developing drug-device combination products? In this episode of Let’s Combinate, Subhi Saadeh breaks down the key distinctions between QbD, used in pharmaceutical development, and design controls, the regulatory framework guiding medical device design. Learn how these two approaches tackle product realization, why they're not interchangeable, and how both are essential when building safe, effective, and compliant combination products. Whether you work in drug development, medical devices, or the space in between, this episode will help you: -Understand the regulatory foundations of QbD (ICH Q8) and design controls (FDA 21 CFR 820.30) -Learn the core tools and deliverables (like CQAs, QTPP, design verification & validation, and risk assessments) -See how each system addresses user needs, therapeutic effects, and process control -Apply both systems effectively in combination product developmentTimestamps: 00:00 – Intro: Why Compare QbD and Design Controls? 01:31 – Philosophical Differences: Process vs. Product Control 03:10 – Practical Examples: Drugs vs. Devices 05:13 – Origins and Frameworks: ICH Q8 and Design Controls Regulation 06:46 – Deep Dive: What Are Design Controls? (Inputs, Outputs, DHF, V&V, Transfer) 11:51 – What Is Quality by Design (QbD)? (QTPP, CQAs, Design Space, DOE) 15:39 – Final Takeaways: How to Use Both in Combination Products 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. ------------------------ ICH Q8, Q9, Q10, and Q12ISO 14971 Risk ManagementDifferences between usability engineering and clinical trialsThe role of control strategies and process monitoring in pharmaRelevant for:Regulatory affairs professionalsQuality engineers in pharma and medtechDrug/device development teamsAnyone preparing for combination product submissions or audits…

Let's Combinate - Drugs + Devices

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186 - 4 Ways to Future-Proof Your Career in Pharma, Medical Devices and BioTech 12:38

5 weeks ago12:38

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

6 weeks 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

1
184 - Program Management in Pharma & Devices: Phase Gates, Risk Planning, and Project FMEAs Explained 30:37

7 weeks 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

1
183 - GxP Explained: A Complete Guide to Good Manufacturing, Clinical, Laboratory, and Distribution Practices for Regulated Products 37:11

8 weeks 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

9 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

10 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

11 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

12 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

13 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

14 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

15 weeks ago26:20