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Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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All About Change


1 Tiffany Yu — Smashing Stereotypes and Building a Disability-Inclusive World 30:23
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Tiffany Yu is the CEO & Founder of Diversability, an award-winning social enterprise to elevate disability pride; the Founder of the Awesome Foundation Disability Chapter, a monthly micro-grant that has awarded $92.5k to 93 disability projects in 11 countries; and the author of The Anti-Ableist Manifesto: Smashing Stereotypes, Forging Change, and Building a Disability-Inclusive World. As a person with visible and invisible disabilities stemming from a car crash, Tiffany has built a career on disability solidarity. Now that she has found success, she works to expand a network of people with disabilities and their allies to decrease stigmas around disability and create opportunities for disabled people in America. Episode Chapters 0:00 Intro 1:26 When do we choose to share our disability stories? 4:12 Jay’s disability story 8:35 Visible and invisible disabilities 13:10 What does an ally to the disability community look like? 16:34 NoBodyIsDisposable and 14(c) 21:26 How does Tiffany’s investment banking background shape her advocacy? 27:47 Goodbye and outro For video episodes, watch on www.youtube.com/@therudermanfamilyfoundation Stay in touch: X: @JayRuderman | @RudermanFdn LinkedIn: Jay Ruderman | Ruderman Family Foundation Instagram: All About Change Podcast | Ruderman Family Foundation To learn more about the podcast, visit https://allaboutchangepodcast.com/…
Automating Quality
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Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.
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61 episodes
Mark all (un)played …
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Content provided by SOLABS, Mandy Gervasio, and Philippe Gaudreau. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by SOLABS, Mandy Gervasio, and Philippe Gaudreau or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
Welcome to the Automating Quality show sponsored by SOLABS, with your host Mandy Gervasio, Technology and Life Sciences industry veteran. The Automating Quality podcast is designed to provide professionals in the regulated Life Sciences industry with best practice perspectives as well as employable strategies and tools relevant to current industry trends. Listeners will come to understand pressing issues in the space and hear best in class thought leadership on various topics such as Quality, Training and Regulatory Compliance driven from an automation lens.
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61 episodes
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Automating Quality

1 Episode 61: Value Added Quality with Ed Siurek 27:07
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Welcome to Automating Quality , the life sciences–focused show that bridges the gap between automation and quality management. In today’s episode, Ed and Philippe explore how quality can bring added value to a company and discuss strategies to shift organizational mindsets to unlock the full potential of quality departments. Ed Siurek brings over 30 years of hands-on experience in applying quality standards and ensuring regulatory compliance in the pharmaceutical and medical device industries. He has trained hundreds of quality professionals and is a strong advocate for positioning quality as a driver of business value. After 13 years with a consulting firm, Ed recently transitioned full-time to his own company, ES3 Solutions Inc. Key Takeaways 00:53 – Introducing Ed Siurek 02:20 – Why is quality sometimes perceived as a cost? 05:50 – Always remember: our products are ultimately used on people 09:02 – “If it’s not written down, it didn’t happen” 10:20 – Use your risk report — don’t let it collect dust 13:20 – How are regulatory bodies viewed in the industry today? 21:15 – What is the role of a quality plan? Contact us at solabs-podcast@solabs.com for questions or suggestions. Contact Ed Siurek at Always improving ES3 Solutions…
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Automating Quality

1 Episode 60: Investigative Methods with Michael Tyo 18:34
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Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management. In today’s episode, Michael and Philippe discuss investigation methods, how to apply them in detail, and the various tools available for conducting investigations. Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting. Key Takeaway 01:24 Introducing today’s guest: Michael Tyo 01:55 Today’s topic is investigative methods and what happens when things go wrong 03:36 The Fishbone method 06:28 Why human error cannot be a root cause? 07:55 The 5 Whys method 09:35 What needs to be included in the investigation report? 11:30 What does the FDA expect from investigations? 12:38 Lessons from recent FDA’s warning letters Contact Michael at mtyo@tyobio.com , Tyo Biotechnology Consulting Contact solabs at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 59: Introduction to Investigations with Michael Tyo 18:31
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Automating Quality Episode 59 – Inspection Readiness with Michael Tyo Welcome to Automating Quality, the Life sciences-centric show that bridges the gap between automation and quality. In today’s episode, we discuss inspection readiness, from why we are doing them to how to conduct investigations properly. Michael Tyo has worked in the biotech industry for 45 years, from engineering roles to quality assurance. Michael is now consulting at Tyo Biotechnology Consulting. Key Takeaways 00:42 Introducing today’s guest: Michael Tyo 01:42 Today’s subject is the investigations, from why they exist to how they must be performed 02:22 Why are we doing investigations? 04:21 What may trigger an investigation? 08:04 What must be investigated? 10:00 Who is responsible for doing investigations? 14:41 What are the tasks once the investigation is launched? Contact Michael at mtyo@tyobio.com , Tyo Biotechnology Consulting Contact solabs at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia 15:12
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Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the second in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. In this episode, we discuss the definition of AIBOM, how it differs from SBOM, and take an educated guess at their future. Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely knowledgeable about the regulatory landscape, and we frequently refer to him for his regulatory expertise. Key Takeaways; 01:05 Introducing guest Joseph Silvia 02:20 What is the concept of AIBOM? 04:23 Why AIBOM and SBOM should be separate discussions 07:45 How does open-source software impact those bills of material 11:22 How do you assess the risk of an AIBOM? Contact us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia 16:36
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Welcome to Automating Quality, the life sciences-centric show that bridges the gap between automation and quality management systems. This episode is the first in a two-part series discussing the Software Bill of Materials (SBOM) with guest Joseph Silvia. We explore the history of SBOM, its current importance for the FDA, and how to ensure you have an SBOM in place when implementing or developing medical devices. "Joseph is the CEO of MedWareCyber, a consulting firm specializing in FDA readiness, cybersecurity, and software readiness for the medical devices industry. He is extremely knowledgeable about the regulatory landscape, and we frequently refer to him for his regulatory expertise. Key Takeaways 01:10 Introducing today’s guest: Joseph Silvia 02:35 What is an SBOM? 04:24 What is the history of SBOM? 05:50 Now, the government is getting involved and SBOM is picking up steam. 06;35 What is the FDA’s expectation on this topic for the medical devices industry? 09:03 When implementing or developing a device, how do you ensure that you have an SBOM in place to support it? 11:38 Who is responsible for SBOM within organizations? 14:37 Where can listeners learn more about this topic? Reach Joseph at jsilvia@medwarecyber.com Contact us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam 18:08
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This episode is the second in a series on Inspection Readiness featuring guest Caroline Guay-Adam! In this episode, we dive into tips and tricks for maintaining Inspection Readiness including first time right, the importance of the Inspection Manual, and more! Caroline Guay-Adam has over 15 years of experience as a quality professional before joining Skillpad as a Senior Compliance Consultant. She has plenty to share on compliance and has recently been helping clients implement strategies for being and staying inspection-ready. Key Takeaways 01:18 Introducing today’s guest, Caroline Guay-Adam. 02:46 The importance of verifying the effectiveness of corrective actions. 04:55 Focus on what the inspector will be interested in. 06:11 Update the documentation whenever there is a change. 08:48 Employees need to be continuously prepared for inspections. 11:58 You need to have a dedicated Inspection Manual. 16:25 What is the expectation in terms of control of the inspection readiness program? Join us at solabs-podcast@solabs.com Reach out to Caroline at cguayadam@skillpadcompliance.com !…
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Automating Quality

1 Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam 15:19
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quality professionals: inspection readiness! Our guest Caroline Guay-Adam discusses inspection readiness and how to reach and maintain an inspection-ready state over time. Caroline Guay-Adam has over 15 years of experience as a quality professional before joining Skillpad as a Senior Compliance Consultant. She has plenty to share on compliance and has recently been helping clients implement strategies for being and staying inspection-ready. Key Takeaways: 00:42 Introducing today’s guest: Caroline Guay-Adams 03:23 Why is inspection readiness necessary for Life Sciences companies? 05:24 How do you establish a strategy to be and stay inspection-ready? 08:00 What are the requirements for a company to call itself inspection-ready? 13:00 Which mindset is necessary for this strategy to remain successful over time?…
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Automating Quality

1 Episode 54: Risk Management Tools and Techniques with Michael Tyo 15:32
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA’s expectations regarding the use of risk assessment tools. Key Takeaways: 01:11 Introducing Michael and his Background 02:31 Does the FDA have a clear expectation for the use of risk assessment tools? 06:13 The importance of a risk plan 09:20 Why companies must all have an SOP for risk assessment Contact us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo 18:35
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters can be leveraged as a source of information on the FDA’s current areas of focus and how monitoring them can help avoid the FDA’s attention. Key Takeaways 01:04: Michael introduces himself and his background 02:21: How can companies use warning letters as a source of information on the FDA’s current area of focus 04:31: Michael shares a statistical analysis he conducted on warning letters in 2023 08:52: How warning letters give you an idea of what happened at the company 12:31: Understanding warning letters helps companies avoid the FDA’s attention Contact us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 52: Supplier Quality Management w. Mandy Gervasio 17:28
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS, and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma. In this episode, Mandy and Philippe discuss supplier management from establishing a relationship with new suppliers to maintaining this relationship and keeping the trust between your two organizations alive. Key Takeaways: 01:30 Mandy discusses her current role and how it is linked to supplier management 03:40 Being able to work with partners that allow you to operate as one team in a seamless way is an incredible success factor 04:37 Mandy points red flags when entering a relationship with a supplier 07:15 Communicating only when there are problems to manage is a risky behavior 09:03 From a GCP perspective, how can you establish a good relationship with CROs and other suppliers? 13:26 How do you maintain your relationship with those suppliers and keep the trust alive and active?…
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Automating Quality

1 Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio 20:30
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma. In this episode, we explore Mandy’s takeaways from recent quality conferences she attended, from management accountability to the importance of managing data integrity. Key Takeaways 02:06: What are the key conferences Mandy attended this year? 04:49: The importance of keeping management accountable for quality objectives. 06:24: Accountability now revolves around individual responsibilities. 10:21: Data integrity is a recurring theme in discussions. 14:30: Training on data integrity has evolved in recent years. 16:07: Supplier Management is another important topic. Contact us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve 16:06
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very special 50th episode! We are joined today by Jamie Villeneuve, CEO and Head of Software Development at NexGen Analytics. Jamie will discuss the common challenges GMP shopfloor companies have in terms of analytics, how this evolved over time, and more! Key Takeaways 01:01 Introducing today’s return guest: Jamie Villeneuve from NexGen Analytics 02:35 What are some of the common challenges in GMP companies from an analytics standpoint? 05:01 What departments need input from analytics? 07:31 How has analytics evolved over time for GMP companies? 10:11 New nomenclature and approach for analytics 11:38 Why do companies invest more and more in analytics? 13:03 The top 5 metrics GMP shopfloor analytics companies need to track 14:42 Thank you to Jamie for joining us for this special episode #50! Contact Jamie at jvilleneuve@solabs.com Contact us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve 16:07
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! We are joined today by Jamie Villeneuve, Owner and Head of Software Development at NexGen Analytics. Jamie will discuss the design of analytics from establishing the organization's goals to providing the right information to the right people at the right time. Key Takeaways 01:58 Introducing today’s guest: Jamie Villeneuve from NexGen Analytics 03:19 Who needs information from analytics in an organization? 05:36 How do you know what information is relevant to report on? 08:52 How do you communicate analytics effectively to all staff at a company? 11:40 Is there a process to review metrics over time and ensure what is measured stays up to date with the company’s needs? 15:12 Thank you to Jamie for joining us! Contact Jamie at jvilleneuve@solabs.com Contact us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia 14:18
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! We are joined today by return guest Joseph Silvia, Director, Software Quality Training, and Instructor at Oriel STAT A MATRIX. In this episode, Joe shares his expertise on Supplier Management Quality for the medical devices industry. We discuss the onboarding process of new suppliers, the future of remote versus on-site audits, and more! Key Takeaways 00:38 Introducing Joseph Silvia and Oriel STAT A MATRIX 02:53 Who are the main parties involved in the medical devices supply chain? 04:15 What is the process to getting a new supplier on board? 07:56 Are all audits in the future going to be remote? 10:04 Do suppliers change their processes to make themselves easier to audit? 12:55 Thanks to Joseph and our listeners for this great episode!…
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Automating Quality

1 Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia 19:02
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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! Our guest today is Joseph Silvia, Director, Software Quality Training and Instructor at Oriel STAT A MATRIX. Joe shares his expertise on the Case for Quality, what to focus on first when implementing a quality system and the differences between Computer Software Validation (CSV) and Computer Software Assurance (CSA), and more! Key Takeaways 02:17 Introducing today’s guest: Joseph Silvia, Director of Software Quality Training and Instruction and Lead Auditor at Oriel Stat A Matrix 03:33 What is the Case for Quality? 05:23 Joseph discusses the importance of having quality at the core of what you do as opposed to adding it as an afterthought 07:44 What is the first thing you should focus on when implementing a quality system? 10:55 Philippe shares his experience on implementing QM10 at SOLABS as part of our quality practices 12:53 The difference between Computer Software Validation (CSV) and Computer Software Assurance (CSA) and how this is impacting risk management 17:38 Thanking Joseph and our listeners for today’s episode! Contact Joseph at jsilvia@orielstat.com or on LinkedIn Oriel STAT A MATRIX: www.orielstat.com Reach out to us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 46 - Defining Data Quality with Steve Gens 17:38
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features Steve Gens, Managing Partner at Gens & Associates. We will define data quality, what happens if the confidence in data quality is low, and provide some recommendations to keep it high. Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021. Key Takeaways 00:49 Introducing today’s guest: Steve Gens, here to discuss Data Quality with us 02:10 Defining Data Quality? 04:00 What happens when the confidence in the data quality is low? 05:48 Steve provides some recommendations related to Data Quality. 10:30 How does Data Quality bring Quality and Regulatory together? 13:26 what are some services Gens & Associates offer related to this topic? Reach out to us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 45 - The World Class RIM Benchmark by Gens & Associates Featuring Steve Gens 22:36
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features Steve Gens, Managing Partner at Gens & Associates. We will discuss the World Class RIM Benchmark conducted by Gens & Associates, how it came into being, and some of its key findings over time. Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021. Key Takeaways 00:45 Introducing today’s topic: The World Class RIM Benchmark by Gens & Associates 01:15 Steve Gens’ Background 02:20 How did the World Class RIM come into being? 05:03 The origin of the RIM acronym 06:00 Steve shares some of the key findings of the benchmark over time 11:21 What does the industry need to get better? 13:10 Where does clinical stand compared to regulatory in terms of standardization 15:15 Is there a correlation between the ROI on new technology and having robust processes? 16:00 What has evolved over time in between those studies? 19:00 What would Steve recommend to students interested in the topic of RIM? 21:30 Thank you to our listeners! Contact us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 44: Good Machine Learning Practices for the Medical Devices Industry with Ben Locwin 15:36
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. The topic of today’s episode is good machine learning practices for the medical devices industry. Ben discusses some good machine learning practices (GMLP) and discusses the importance of standardizing those across the industry over time. Key Takeaways 01:00 Today’s topic is good machine learning practices for the medical devices industry 01:20 Introducing today’s guest: Ben Locwin 03:30 Ben introduces good machine learning practice guiding principles 06:43 How quickly will there be a set standardized framework for good machine learning practices (GMLP)? 11:10 Why this topic matters a lot 12:15 Will new competencies need to be developed for understanding the regulations and techniques in the field of machine learning? 14:36 Thank you to our guests and listeners!…
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Automating Quality

1 Episode 43: Artificial Intelligence and Machine Learning in the Medical Devices Industry with Ben Locwin 20:44
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. Today’s topic of discussion is artificial intelligence and machine learning. Ben delivers some background on those buzzwords, how they relate to the FDA’s action plan, how this will impact the medical device industry moving forward, and more! Key Takeaways 01:22 Introducing today’s guest Ben Locwin 03:26 Some background on artificial intelligence and machine learning 05:24 Common misunderstandings about those buzzwords 07:10 What is deep learning versus machine learning and AI? 08:43 How do these areas relate to the FDA’s action plan? 14:05 How will this impact the medical device industry moving forward? 18:40 Mandy thanks Ben for joining us on the show…
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Automating Quality

1 Episode 42: Gens & Associates' Quality Benchmark with Katherine Yang-Iott 25:46
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! In today’s episode, we will discuss the discoveries of the Quality Benchmark conducted by Gens & Associates in late 2021. Our guest today is Katherine Yang-Iott. She is a consultant and analyst for Gens and Associates and the study lead for the firm’s first Quality-focused benchmark. She’s had 2 decades of experience as a scientist and researcher. Gens & Associates is a Life Science advisory and benchmarking firm founded in 2005 with a focus on the regulatory domain and adjacent areas (quality, clinical, safety). Their respected research community includes active clients and members from over 140 organizations that have participated in one of their 38 benchmark studies. They expanded their benchmark capability into quality with a landmark study in 2021. Key Takeaways 01:32 Introducing today’s guest: Katherine Yang-Iott, an Analyst at Gens & Associates 03:07 Katherine introduces Gens & Associates and the context of this study 06:07 What were the key findings of this survey? 08:50 What is a QMS in the perspective of Katherine 11:12 What was the goal of the study in terms of information produced? 14:20 How the pandemic has increased companies’ focus on supplier management 20:00 Mandy mentions that CAPA is a quality process that companies still struggle to get right today 21:20 Philippe shares his thoughts on the benchmark’s key learnings 22:57 What are the next steps for G&A in the world of quality? 25:15 Mandy thanks our guest and invites listeners to share their feedback…
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Automating Quality

1 Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin 18:22
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. The topic of today’s discussion is the Real-World Evidence framework as defined by the FDA. We highly recommend listening to the previous episode on Real-World Data and Real-World Evidence before diving into this one. Key Takeaways 00:17 Mandy introduces Ben back to the show 01:13 Today’s topic is the Real-World Evidence framework 02:24 What is the FDA’s definition of Real-World Evidence? 06:50 What is being looked at for the framework? 09:16 What are the 4 Vs of data? 11:18 How do you define your hypotheses in advance when looking at data? 15:44 Mandy reflects on today’s discussion…
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Automating Quality

1 Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin 22:01
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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features a conversation with guest expert Ben Locwin. Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. The topic of today’s discussion is about defining what are Real-World Data and Real-World Evidence (RWD & RWE). Key Takeaways 01:13 Introducing today’s guest: Ben Locwin 03:03 Philippe discusses the link between Real-World Data and its connection with technology 05:05 Ben defines Real-World Data and Real-World Evidence 10:28 Philippe discusses the importance of the integrity of data gathered from different sources 12:18 The importance of looking at the data with a specific hypothesis in mind 15:45 There is a lack of standardizing in data that leaves some concern 17:07 What is the FDA looking for regarding Real-World Data and Real-World evidence? 20:00 Ben shares his closing thoughts on the topic Contact us at solabs-podcast@solabs.com…
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Automating Quality

1 Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin 21:02
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Welcome to the 39th episode of Automating Quality . Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! In today’s episode , Mandy Gervasio and Nathalie Bourgouin (the Vice President of Compliance at Skillpad), are continuing on the topic of clinical inspection readiness. This episode is the last in the four-part series. If you haven’t already tuned in to the previous three episodes, be sure to listen to those first before tuning into this one! In Part 1 Mandy and Nathalie discussed the Initiation phase, in Part 2 they discussed the Planning phase and in Part 3 they discussed Execution and Monitoring. This week, they are discussing the Closing phase of clinical inspection readiness! Nathalie discusses the importance of the close-out meeting, provides guidelines for responding to the inspector’s observations and suggests tips for making a useful internal inspection report. Key Takeaways: 0:36 – Mandy introduces today’s topic: GCP Inspection Readiness part 4: Closing the Inspection 1:54 – Nathalie details her background in pharmaceutical and biotech companies 3:45 – Nathalie recaps the first three phases: Preparation, Planning, Execute & Monitor 5:10 – Nathalie explains the key steps of the closing phase 6:45 –Nathalie discusses the importance of preparing for the Close-Out Meeting and what you should expect 9:45 – Nathalie provides some guidelines for responding to the inspector’s observations 13:05 – Nathalie shares her experience in regards to putting together the response 16:00 – Nathalie revisits the importance of the internal inspection report 19:29 – Mandy thanks Nathalie for being on the show and sharing her experience…
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Automating Quality

1 Episode 38: Data Integrity and Data Governance in a Remote Work Environment with Ben Locwin 36:07
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Welcome to the 38th episode of Automating Quality . Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode is a little different than usual. Philippe Gaudreau will be joining Mandy as a co-host in a conversation with guest expert Ben Locwin. Ben is the SVP of Quality at Lumicell and has been working in the life sciences industry for over 25 years. Among other things, he has trained FDA inspectors and participated in the design of the Global Quality Metrics Initiative for the FDA. This week, they are discussing Data Integrity and Data Governance in today’s landscape. Ben explains the difference between data integrity and data governance, discusses the challenges of remote work during COVID-19 from a GxP perspective and breaks down some tips for companies to incorporate work from home in their company culture in a safe and efficient way! Key Takeaways 0 :33 : Mandy introduces today’s co-host Philippe Gaudreau. 1:22 : Mandy introduces today’s guest, Ben Locwin. 2:15: Today’s topic is Data Integrity and Data Governance in today’s remote work culture. 3:02: Ben provides an overview of his background in Life Sciences. 9:15: Ben explains the difference between data integrity and data governance. 9:50: The guests discuss the unique challenges for handling work from home and COVID-19 from a GxP Data Integrity perspective? 11:57: Philippe details some of the dangers for data integrity with employees working from home and shares his opinion on the future of online security. 14:31: Ben stresses the importance of the Quality / Regulatory and IT / Security team members work hand in hand to ensure the integrity of data. 17:15: Ben discusses the delicate balance between ease of use and standardization of inputs and outputs within software. 20:14: The group discusses tips and tricks for remote workers to improve their efficiency. 23:39: Ben insists on the importance of having a routine on the human psyche. 26:10: Mandy insists on the importance of recording important meetings to keep track of information 27:28: Philippe gives some tips for companies to incorporate work from home in their company culture in the long term. 30:27: Mandy suggests reviewing data governance policies and ensuring that the team is comfortable with working from home. 31:55: Ben stresses the importance of having clear data governance policies in the future. 33:53: Mandy thanks Ben and Philippe and reflects on today’s learnings. Mentioned in this episode Ben Locwin on LinkedIn Mandy.Podcast@Solabs.com…
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Automating Quality

1 Episode 37: Clinical Inspection Readiness: the Execution and Monitoring Phase with Nathalie Bourgouin — Part 3 17:19
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Welcome to the 37th episode of Automating Quality . Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! In today’s episode , Mandy Gervasio and Nathalie Bourgouin (the Vice President of Compliance at Skillpad), are continuing last week’s topic on clinical inspection readiness. This episode is part three in the four-part series. If you haven’t already tuned in to the previous two episodes, be sure to listen to those first before tuning into this one! In episode one, Mandy and Nathalie discussed the initiation phase, and in episode two, they discussed the planning phase. This week, they are discussing the execution and monitoring phase of clinical inspectional readiness! Nathalie gets into the details of the various considerations and different stages of this phase and breaks down some of the most important key aspects. This phase is all about what to do once the inspector actually arrives — so don’t miss out on learning more about this crucial step! Key Takeaways: [:31] About today’s episode, the third part of the four-part series. [:45] Mandy recommends listening to the previous two episodes before tuning into this one. [1:00] Mandy welcomes Nathalie back on the podcast. [1:29] Mandy introduces the third phase: execute and monitor. [1:42] Mandy thanks Nathalie once again for joining the podcast! [2:08] Nathalie brings listeners up to speed on what was discussed in previous episodes. [2:34] Nathalie introduces the topic this week: the execution and monitoring phase. [3:04] Nathalie highlights the key tasks during the execution and monitoring phase. [4:43] Nathalie explains how to pull the necessary data together for the first task: gathering the known issues and the available intelligence. [6:11] Nathalie gives her advice regarding preparing a list of potential GCP issues. [7:44] The key documents that need to be prepared prior to the inspection. [10:56] Nathalie highlights some details regarding inspection expectations and shares what the day of the inspection will likely look like. [12:46] Nathalie gives best practice advice for making sure things move along as planned. [14:40] Nathalie provides further insight into monitoring progress and the identification of issues. [16:02] About the final episode in the four-part series covering the final phase: closing the inspection. [16:23] Mandy thanks Nathalie for sharing her insights in this episode and reiterates what the next and final episode in the series will be covering. Mentioned in this Episode: Nathalie Bourgouin’s LinkedIn Mandy.Podcast@Solabs.com…
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Automating Quality

1 Episode 36: Clinical Inspection Readiness: the Planning Phase with Nathalie Bourgouin — Part 2 25:31
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Welcome to the 36th episode of Automating Quality . Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! On today’s episode of Automating Quality, Mandy Gervasio and Nathalie Bourgouin, the Vice President of Compliance at Skillpad, are continuing last week’s topic on clinical inspection readiness. This episode is part two in a four-part series. In the previous episode, Mandy and Nathalie took a look at the initiation phase of GCP inspection readiness. This phased approach that Nathalie has put together has made it easy for listeners to synthesize this topic effectively. Mandy and Nathalie know how technical and challenging it can be to maintain expertise in various areas. So, if you are fairly new to the life sciences industry this series will be incredibly beneficial in learning more about inspection readiness planning! Be sure to tune in to the second part in this series as they focus on the planning phase of GCP inspection readiness and break down the key aspects. Key Takeaways: [:32] About today’s episode, the second part in a four-part series. [2:43] Mandy welcomes Nathalie back on the podcast. [2:50] Nathalie brings listeners up to speed on what was previously discussed. [3:55] Nathalie explains the project planning phase that follows the initiation phase. [5:00] Nathalie details the three main tasks in the planning phase: preparing the plan, execution, and monitoring. [5:50] Nathalie explains the goals of the inspection readiness plan. [7:00] Nathalie walks listeners through the typical paths of actions that should be outlined in the readiness plan. [10:45] Nathalie provides additional tips on key actions to consider when preparing your team for the inspection. [13:21] Mandy emphasizes that it is normal and expected to refer to procedure during the audit. You are not required to know everything by heart! [14:07] Nathalie gives her recommendations on general guidelines for interacting with inspectors. [16:34] The do’s and don’ts when interacting with an inspector. [18:43] Nathalie’s #1 piece of advice for interacting with an inspector. [20:42] Mandy and Nathalie highlight the importance of knowing when to ask for help. [23:02] Nathalie explains the last task of the planning phase: monitoring the deliverables. [24:02] Mandy wraps up this week’s episode by thanking Nathalie, reflecting on today’s learnings, and announcing the next show in the series: the monitoring phase. Mentioned in this Episode: Nathalie Bourgouin’s LinkedIn Mandy.Podcast@Solabs.com…
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Automating Quality

1 Episode 35: Clinical Inspection Readiness: the Initial Stage with Nathalie Bourgouin — Part 1 20:14
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Automating Quality

1 Episode 34: Artificial Intelligence from a Life Sciences’ Perspective 23:36
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Automating Quality

1 Episode 33: Case Study for Implementing an EQMS from a System Owner’s Lens 37:21
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Automating Quality

1 Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020 26:08
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