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SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests

Automating Quality

A Life Sciences , Science and Technology podcast

#101 in Life Sciences · 🇩🇰 #124 in Life Sciences · 🇸🇪
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About the show

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.

Newest episodes

Episode 69 - AI and FMEA: The Dynamic Between Automation and Human Judgment with Dr. John Salvato

24 min

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. In Part 2 of this two-part series, Philippe Gaudreau continues the conversation with Dr. John Salvato, founder of Design Quality Services and an ISO 13485 lead auditor with more than 30 years of experience in medical device and automotive engineering. Having covered the foundations of design controls and FMEA in Part 1, the conversation now turns to where artificial intelligence fits into risk management and design documentation, and where it does not. Salvato distinguishes what AI can responsibly accelerate in FMEA from what it cannot. Once a methodology is structured around clear rubrics, he explains, AI can apply it almost instantly. Weighing the benefit of a device against its residual risk, however, remains a human judgment shaped by each organization's own risk tolerance, not something AI can determine. He also warns against "AI slop," content that looks polished and authoritative in design file generation but may not hold up to scrutiny. To guard against it, Salvato recommends building skill documents, akin to work instructions, that teach an AI tool a defined methodology, paired with the subject-matter expertise needed to recognize whether the output is sound. As AI takes on drafting work once done by junior engineers, Salvato frames the professional's role as shifting toward reviewing, distilling, and ultimately approving what the tool produces. Evaluating an AI-generated DFMEA or safety risk analysis, he stresses, demands the same depth of training and experience organizations have always needed to sign off on that work. AI can speed up the paperwork of risk management, but it cannot own the judgment behind it. Key Takeaways 0:00 Looking back at Part 1 and introducing today's topic: AI and FMEA 1:45 Reintroducing guest John Salvato, founder of Design Quality Services 4:35 Where AI can responsibly...

Episode 68 - From Stethoscopes to Smart Devices: FMEA in a Complex Device Landscape with Dr John Salvato

24 min

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. This is the first installment of a two-part series on design controls and risk management in medical device development with guest Dr. John Salvato, founder of Design Quality Services and an ISO 13485 lead auditor with over 30 years of experience in medical device and automotive engineering. Together with our host Philippe Gaudreau, they argue that as devices grow more connected and AI-enabled, foundational tools like design controls and FMEA matter more, not less. John traces FMEA's origins from the U.S. military in the 1940s to NASA's Apollo program and Ford's automotive use in the 1970s. He contrasts legacy devices like stethoscopes, with their handful of known failure modes, against today's wearable and connected devices, where added functions and data flows multiply the failure modes engineers must account for. The conversation turns to new risks from connectivity and embedded AI/ML models, and to "thin data,". The episode's throughline is that design controls and FMEA, far from outdated paperwork, remain the engineering backbone that novel, complex devices depend on. Key Takeaways 01:19 Introducing today's topic: design controls and FMEA 02:33 Introducing today's guest, Dr. John Salvato 06:27 The origins of FMEA, from military use to NASA and automotive 10:44 Why design fundamentals matter more as devices grow complex 16:49 New risk categories from wearable and connected devices 20:53 The concept of "thin data" in novel device risk estimation 24:14 The QMSR change and the end of legacy device exemptions Contact us at solabs-podcast@solabs.com Contact Dr John Salvato: https://www.linkedin.com/in/john-salvato-ph-d-987b1b6/

Episode 67 - Leveraging AI for Proactive Quality with Niyati Patel

30 min

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. In the third and final episode of this series, Philippe closes out the conversation with Niyati Patel, Strategic Quality and Compliance Advisor, returning to explore how life sciences organizations can shift from reactive to proactive quality as AI adoption matures. Niyati distinguishes reactive quality, asking what went wrong after the fact, from proactive quality, asking what pattern signals a problem before it occurs. Drawing on a CDMO case, she shows how AI can connect deviations that look unrelated in isolation, such as operator error, equipment malfunction, and process inadequacy, into an actionable trend. The conversation turns to the industry's move toward integrated architectures connecting ERP, EQMS, and LIMS. Niyati illustrates this with a supplier quality example, then explains how a CSA approach to system interfaces shifts validation focus from exhaustive test scripts toward risk-based confidence in a system's intended use. Returning to AI, Niyati outlines five factors to weigh before moving a tool from experimentation to operational use: business value, risk, data quality, human oversight, and scalability. She walks through validating an AI tool built to accelerate investigation research, applying the same risk-based, CSA-style rigor used for any GxP system. AI can accelerate the pace of quality work, but the judgment behind every decision remains with the quality professional. Key Takeaways 00:22 Introducing today's topic: from reactive to proactive quality 01:20 Reintroducing guest Niyati Patel and catching up since Parts 1 and 2 05:34 What separates reactive quality from proactive quality 06:32 Case example: connecting unrelated deviations into a single trend 10:36 The shift toward enterprise-wide, integrated system architectures 14:55 Case example: integrating ERP and EQMS for supplier...

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All episodes

Episode 69 - AI and FMEA: The Dynamic Between Automation and Human Judgment with Dr. John Salvato

24 min

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. In Part 2 of this two-part series, Philippe Gaudreau continues the conversation with Dr. John Salvato, founder of Design Quality Services and an ISO 13485 lead auditor with more than 30 years of experience in medical device and automotive engineering. Having covered the foundations of design controls and FMEA in Part 1, the conversation now turns to where artificial intelligence fits into risk management and design documentation, and where it does not. Salvato distinguishes what AI can responsibly accelerate in FMEA from what it cannot. Once a methodology is structured around clear rubrics, he explains, AI can apply it almost instantly. Weighing the benefit of a device against its residual risk, however, remains a human judgment shaped by each organization's own risk tolerance, not something AI can determine. He also warns against "AI slop," content that looks polished and authoritative in design file generation but may not hold up to scrutiny. To guard against it, Salvato recommends building skill documents, akin to work instructions, that teach an AI tool a defined methodology, paired with the subject-matter expertise needed to recognize whether the output is sound. As AI takes on drafting work once done by junior engineers, Salvato frames the professional's role as shifting toward reviewing, distilling, and ultimately approving what the tool produces. Evaluating an AI-generated DFMEA or safety risk analysis, he stresses, demands the same depth of training and experience organizations have always needed to sign off on that work. AI can speed up the paperwork of risk management, but it cannot own the judgment behind it. Key Takeaways 0:00 Looking back at Part 1 and introducing today's topic: AI and FMEA 1:45 Reintroducing guest John Salvato, founder of Design Quality Services 4:35 Where AI can responsibly...

Episode 68 - From Stethoscopes to Smart Devices: FMEA in a Complex Device Landscape with Dr John Salvato

24 min

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. This is the first installment of a two-part series on design controls and risk management in medical device development with guest Dr. John Salvato, founder of Design Quality Services and an ISO 13485 lead auditor with over 30 years of experience in medical device and automotive engineering. Together with our host Philippe Gaudreau, they argue that as devices grow more connected and AI-enabled, foundational tools like design controls and FMEA matter more, not less. John traces FMEA's origins from the U.S. military in the 1940s to NASA's Apollo program and Ford's automotive use in the 1970s. He contrasts legacy devices like stethoscopes, with their handful of known failure modes, against today's wearable and connected devices, where added functions and data flows multiply the failure modes engineers must account for. The conversation turns to new risks from connectivity and embedded AI/ML models, and to "thin data,". The episode's throughline is that design controls and FMEA, far from outdated paperwork, remain the engineering backbone that novel, complex devices depend on. Key Takeaways 01:19 Introducing today's topic: design controls and FMEA 02:33 Introducing today's guest, Dr. John Salvato 06:27 The origins of FMEA, from military use to NASA and automotive 10:44 Why design fundamentals matter more as devices grow complex 16:49 New risk categories from wearable and connected devices 20:53 The concept of "thin data" in novel device risk estimation 24:14 The QMSR change and the end of legacy device exemptions Contact us at solabs-podcast@solabs.com Contact Dr John Salvato: https://www.linkedin.com/in/john-salvato-ph-d-987b1b6/

Episode 67 - Leveraging AI for Proactive Quality with Niyati Patel

30 min

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. In the third and final episode of this series, Philippe closes out the conversation with Niyati Patel, Strategic Quality and Compliance Advisor, returning to explore how life sciences organizations can shift from reactive to proactive quality as AI adoption matures. Niyati distinguishes reactive quality, asking what went wrong after the fact, from proactive quality, asking what pattern signals a problem before it occurs. Drawing on a CDMO case, she shows how AI can connect deviations that look unrelated in isolation, such as operator error, equipment malfunction, and process inadequacy, into an actionable trend. The conversation turns to the industry's move toward integrated architectures connecting ERP, EQMS, and LIMS. Niyati illustrates this with a supplier quality example, then explains how a CSA approach to system interfaces shifts validation focus from exhaustive test scripts toward risk-based confidence in a system's intended use. Returning to AI, Niyati outlines five factors to weigh before moving a tool from experimentation to operational use: business value, risk, data quality, human oversight, and scalability. She walks through validating an AI tool built to accelerate investigation research, applying the same risk-based, CSA-style rigor used for any GxP system. AI can accelerate the pace of quality work, but the judgment behind every decision remains with the quality professional. Key Takeaways 00:22 Introducing today's topic: from reactive to proactive quality 01:20 Reintroducing guest Niyati Patel and catching up since Parts 1 and 2 05:34 What separates reactive quality from proactive quality 06:32 Case example: connecting unrelated deviations into a single trend 10:36 The shift toward enterprise-wide, integrated system architectures 14:55 Case example: integrating ERP and EQMS for supplier...

Episode 66 - From Framework to Practice: Governing AI in GxP Environments with Niyati Patel

20 min

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. In Part 2 of this three-part series, Mandy and Philippe continue the conversation with Niyati Patel, Strategic Quality and Compliance Advisor, shifting from theory to execution: how organizations are operationalizing AI in GxP environments. This episode dives into the practical realities of AI governance, focusing on lifecycle management, data boundaries, and the human role in processes involving AI. The discussion unpacks how organizations can structure AI frameworks around intended use, risk classification, data governance, and continuous monitoring, highlighting that AI success is driven less by the model and more by people, policies, and control systems. The conversation also explores what can and cannot be shared with AI tools, outlining clear distinctions between acceptable, restricted, and prohibited use cases. From SOP generation to critical quality decisions, Niyati breaks down how leading organizations are defining guardrails to enable safe adoption. Finally, the episode emphasizes that AI is an assistant, not a decision maker.   Key Takeaways 01:22 Looking back at part 1 02:00 Introducing today's guest Niyati Patel 05:00 How do organizations safely use AI right now? 07:55 Continuous monitoring is critical for systems that evolve over time 10:10 Which data must be protected when giving access to data to your AI? 11:30 How do you get comfortable using AI as an organization? 15:51 What are some good use cases for AI use in regulated industries?   Please contact us at solabs-podcast@solabs.com if you have questions or comments. Mandy Gervasio Niyati Patel Philippe Gaudreau

Episode 65 - From CSV to CSA: Rethinking Validation in the Age of AI with Niyati Patel

25 min

Welcome to Automating Quality, the life sciences–focused show exploring how quality, risk, and technology intersect to modernize regulated environments. In this episode, Mandy and Philippe are joined by Niyati Patel, Strategic Quality and Compliance Advisor with 20+ years of experience across pharma, biotech, medtech, and regulated digital implementations. Niyati specializes in the intersection of quality, validation, and digital transformation. Together, they unpack how validation is evolving in the transition from Computer System Validation (CSV) to Computer Software Assurance (CSA). The discussion challenges common misconceptions, emphasizing that the real shift is toward risk-based thinking, lifecycle control, and deeper system understanding rather than documentation-heavy compliance. The conversation then moves into AI. Niyati outlines how organizations should rethink validation frameworks to focus on boundaries, governance, and human oversight, positioning AI as decision support rather than decision-making. Through practical examples and real-world use cases, this episode sets the foundation for understanding how quality leaders can responsibly adopt AI while maintaining compliance, control, and trust.   Key Takeaways 01:09: Introducing today's topic 03:24: Niyati's background 05:43: What is CSV (and its limitations) 09:06: What CSA actually changes 10:41: Validation rigor is NOT reduced 14:00 Why AI breaks traditional validation 16:23: Why AI must be used for decision support, not autonomous decision making 19:13: Example of AI validation framework 23:40: What validation now proves Please contact us at solabs-podcast@solabs.com if you have questions or comments. Mandy Gervasio Niyati Patel Philippe Gaudreau

Episode 64: Compliance in the Biotech Industry with Paul Michel

23 min

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In this episode, our host Philippe welcomes Paul Michel, Senior Consultant at SkillPad, with over 27 years of experience in the pharmaceutical and biopharmaceutical industries, including more than two decades in manufacturing. Paul specializes in GMP training, compliance readiness, and supporting organizations through the complexities of product development and commercial manufacturing. Together, they explore the realities of GxP compliance in biopharma manufacturing — from the scientific complexity of biologics and evolving regulatory expectations to the growing demand for specialized quality skills and the expanding role of CDMOs. The conversation highlights how automation, digital maturity, and strong quality foundations are becoming essential to sustain growth in this fast-evolving sector.   Key Takeaways 02:11 Why biologics manufacturing is fundamentally more complex than small molecule production 04:10 How living cell systems introduce variability and demand tight process control 05:29 Why scale-up in biomanufacturing is scientifically challenging and risk-prone 10:00 The role of ICH Q5 guidelines and comparability studies in biologics compliance 13:06 The growing demand for advanced quality skills in biologics and digital environments 17:18 How modern CDMOs enable faster development from DNA to IND through platform approaches 20:47 Why automation and digitalization are critical to closing the CDMO capacity gap   Contact Paul Michel on LinkedIn here: Paul Michel (He/Him) | LinkedIn Contact us at solabs-podcast@solabs.com for questions or feedback!

Episode 63 - Qualification of Software Vendors with Masha Ivankovic

16 min

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In this episode, our host Philippe welcomes Masha Ivankovic, President and Owner of Monbel Consultants. With more than 15 years of experience supporting pharmaceutical and biotech companies, Masha has led complex engineering, validation, and regulatory projects across highly regulated environments. Together, they explore the increasingly critical topic of qualifying software providers, why it matters, when it should start, and how proper qualification streamlines software validation and long-term compliance. Masha breaks down practical risk-based strategies, key questions to ask vendors, and how to align expectations early to ensure smoother implementations.   Key Takeaways 00:41 Introducing today's guest, Masha Ivankovic from Monbel Consultants 01:25 Masha's background and the services Monbel Consultants provides 02:37 Why qualifying a software provider is now essential in regulated industries 04:47 When vendor qualification should begin vs. when it usually does 06:30 How risk-based thinking shapes software provider qualification 07:40 Examples of risk criticality 09:19 Key qualification criteria and questions to assess provider maturity 11:10 How strong vendor qualification improves software validation success 13:13 What triggers re-qualification and typical lifecycle expectations 15:10 Closing thoughts and where to learn more about Monbel Consultants   Contact solabs-podcast@solabs.com for suggestions or inquiries. For direct inquiries, Masha can be reached at: masha.ivankovic@monbeltech.com

Episode 62: Leveraging Internal Audits with Jim Ferguson

23 min

Welcome to Automating Quality, the life sciences–focused show that bridges the gap between automation and quality management. In today's episode, our host Philippe welcomes Jim Ferguson, President and Owner of NuQual Consulting. With over 25 years of experience in the life sciences industry, Jim brings deep expertise in supplier quality and compliance. Together, they dive into the world of internal audits — how they can be used not only to maintain compliance but also to proactively identify and resolve potential observations before a regulatory inspection takes place.   Key Takeaways 01:22 Introducing today's guest, Jim Ferguson from NuQual Consulting 02:18 What quality-focused events has Jim been attending lately? 04:30 How can internal audits help organizations prepare for regulatory inspections or other types of audits? 07:25 What is the value of outsourcing internal audits? 08:35 How can companies ensure that audit findings actually lead to meaningful changes? 12:57 What does a strong response to internal audit findings look like? 17:30 What are some common pitfalls organizations tend to overlook during internal audits?   Contact Jim at https://nuqualconsulting.ca/ Contact us at solabs-podcast@solabs.com

Episode 61: Value Added Quality with Ed Siurek

27 min

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

Episode 60: Investigative Methods with Michael Tyo

18 min

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

Episode 59: Introduction to Investigations with Michael Tyo

18 min

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

Episode 58: Discovering AIBOM and the Future of SBOM with Joseph Silvia

15 min

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

Episode 57: Introduction to the Software Bill of Materials with Joseph Silvia

16 min

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

Episode 56: Tips and Tricks for Maintaining Inspection Readiness with Caroline Guay-Adam

18 min

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!

Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam

15 min

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?

Episode 54: Risk Management Tools and Techniques with Michael Tyo

15 min

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

Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo

18 min

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

Episode 52: Supplier Quality Management w. Mandy Gervasio

17 min

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?

Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio

20 min

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

Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve

16 min

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

Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve

16 min

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

Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia

14 min

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!

Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia

19 min

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

Episode 46 - Defining Data Quality with Steve Gens

17 min

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

Episode 45 - The World Class RIM Benchmark by Gens & Associates Featuring Steve Gens

22 min

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

Episode 44: Good Machine Learning Practices for the Medical Devices Industry with Ben Locwin

15 min

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!

Episode 43: Artificial Intelligence and Machine Learning in the Medical Devices Industry with Ben Locwin

20 min

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

Episode 42: Gens & Associates' Quality Benchmark with Katherine Yang-Iott

25 min

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

Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin

18 min

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

Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin

22 min

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

Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin

21 min

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

Episode 38: Data Integrity and Data Governance in a Remote Work Environment with Ben Locwin

36 min

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...

Episode 37: Clinical Inspection Readiness: the Execution and Monitoring Phase with Nathalie Bourgouin — Part 3

17 min

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] Nathali...

Episode 36: Clinical Inspection Readiness: the Planning Phase with Nathalie Bourgouin — Part 2

25 min

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...

Episode 35: Clinical Inspection Readiness: the Initial Stage with Nathalie Bourgouin — Part 1

20 min

Welcome to the 35th 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 show is pretty exciting! Mandy is going to be revisiting a topic that Automating Quality covered a bit last season around the GCP space. Joining her to discuss this topic is a veteran guest of the show who previously introduced the GCP topic — Nathalie Bourgouin! Nathalie is the Vice President of Compliance at Skillpad, which is a sister company of SOLABS. With nearly 30 years of experience in pharmaceuticals and biotech in North America and Europe, Nathalie is a leader in compliance, quality, and project management, with a solid background in risk-based quality assurance processes, training, and auditing. She has planned and audited many GMP and GCP vendors, as well as numerous clinical sites in local and global studies.   Nathalie is kicking off this episode as the first in a four-part series around GCP inspection readiness from a phased approach perspective. Each of the four episodes will take a look at inspection readiness from four different stages, with the first one being the 'Initiation' phase.   For those that have yet to be involved in an inspection or in inspection readiness planning, this episode will be especially beneficial!   Key Takeaways: [:33] Mandy introduces this episode's topic. [1:18] Nathalie Bourgouin introduces herself and provides a background of her career. [2:29] Nathalie further explains the topic for today's episode and the content the full four-part series will cover. [3:07] Nathalie explains what inspection readiness truly refers to. [5:04] What are the first steps you should take when a regulatory agency comes knocking at the door? [7:09] Nathalie further defines the Initiate stage and explains why it is so critical. [8:37] How is an inspection "confirmed"? [10:11] Nathalie breaks down the Initiation stage from a task persp...

Episode 34: Artificial Intelligence from a Life Sciences' Perspective

23 min

Welcome to the 34th 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 this week's episode, Mandy Gervasio is bringing you a fascinating and timely topic to discuss: Artificial Intelligence or AI. This technical niche and hot industry trend of adoption is quite fascinating and you've probably been hearing this term a lot — especially in the last year or two!   She's going to discuss the impact of AI on the life sciences industry as well as some considerations from a regulatory lens. She's going to shed light on some of the key tools that are setting precedents in the industry as well as considerations from a regulatory compliance perspective.  From the veteran with 10+ years of experience to those who are just newly entering the industry, this episode will surely provide key insights that will be of benefit to both!   Key Takeaways: [:38] About today's episode: artificial intelligence from the life sciences' perspective. [2:04] Mandy starts off the episode by defining the term artificial intelligence, or AI. [2:59] Mandy speaks about the research and development phase (or R&D phase) of a product development life cycle and the adoption they're starting to see with regards to AI tools. [4:48] Mandy shares some examples of how AI technology is driving changes in life sciences and making significant impacts on public health. [6:07] Mandy discusses where she's seeing more rapid adoption of AI technology and how it is driving positive change in the life sciences landscape, starting by focusing on the R&D phase. [10:06] Mandy highlights another key trend they're seeing for AI deployment as it relates to clinical trial design. [11:09] Mandy discusses some key challenges that life sciences are faced with in light of this cutting-edge technology. [13:44] Mandy stresses the importance of developing and deploying a clear vision prior to adopt...

Episode 33: Case Study for Implementing an EQMS from a System Owner's Lens

37 min

Welcome to the 33rd 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, Mandy is joined by her co-host, the CEO and founder of SOLABS, Philippe Gaudreau, to bring you a bit of a different episode than usual! They're going to be walking listeners through a case study that is incredibly relevant to their friends and partners in life sciences in terms of system ownership. These are the things that you may encounter and should consider as part of a case study related to implementing a new EQMS system from the system owner's lens within the quality function.    Philippe will be playing the role of Mandy's guest expert as well as the QA Director who will be owning this initiative in the case study. Together, Mandy and Philippe will be walking listeners through what they feel are some of the most important things that you'll face if you have not yet engaged in this type of initiative.    Key Takeaways: [:33] Mandy Gervasio welcomes Philippe Gaudreau to the podcast and introduces today's subject: a case study for implementing a new EQMS from the system owner's perspective. [2:55] Mandy explains the roles that she and Philippe will be taking for the case study. [3:29] Mandy explains the case study format/situation they will be exploring in today's episode. [6:06] Philippe starts by providing his first (of three) recommendations for beginning the implementation process. [7:00] Philippe highlights the areas and roles where you need different people in this process. [9:18] Philippe stresses the importance of having a steering committee involved. [10:07] Philippe continues explaining other important and key roles in this process. [12:36] Mandy highlights some other fantastic episodes related to today's subject for listeners who want to dive deeper and learn more. [14:07] Philippe provides his second recommendation for the implementation process...

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

26 min

Welcome to the 32nd 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 kicking off season 3! Mandy is joined by her co-host, the CEO and founder of SOLABS, Philippe Gaudreau. Together, they will be discussing some of the major trends in automation for the life sciences industry in 2020.    If you want to know about the upcoming hot topics and trends to be aware of and prepare for in order to stay current and competitive in this ever-changing business landscape, be sure to tune in! These hot trends will be sure to add value to your current and future roles in the space of life sciences.   Key Takeaways: [:25] About today's episode! [1:13] Mandy thanks listeners for tuning in through seasons 1 and 2. [1:49] Philippe joins in to thank listeners as well, and speaks a bit about what to expect for today's episode. [3:13] Hot topic areas that are increasing visibility and growth for the life sciences. [6:28] Mandy elaborates on the notion of data analytics. [7:33] Philippe shares his perspective on big data and data analytics and where it's headed in terms of driving changes within life sciences. [11:41] The way technology is shifting in life sciences. [13:16] Progress in mobile med device apps and wearable tech. [14:50] Philippe's thoughts on mobile med device apps and wearable tech. [17:54] What blockchain technology is and how it is entering the life sciences. [19:29] An upcoming hot trend (to be discussed in a future episode): serialization. [20:11] Wrapping up the show, Philippe gives some thoughts on another hot trend: single sign-on solutions. [24:35] Mandy wraps up the show and thanks listeners for tuning in as always!   Mentioned in this Episode: Automating Quality Ep. 21: "Michael de la Torre on GMP Inspection Analytics" Automating Quality Ep. 29: "Data Migration and Data Integrity with Philippe Gaudreau"...

Episode 31: Guest Tribute Show: 'Best of' Moments from the Last Two Seasons!

27 min

Welcome to the 31st 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! And today, she is joined by her co-host, Philippe Gaudreau, the founder and CEO of SOLABS.   Today's show is dedicated to all the SOLABIAN friends who have tuned in for each episode and have supported Automating Quality's journey for the past two seasons! Mandy and Philippe have been on this thought leadership mission for one and a half years now, partnering with life sciences subject matter experts to bring relevant industry trends and best practices to the forefront.   In this episode, they will be taking a look back at the last two seasons, highlighting some of the best clips from previous episodes. Mandy and Philippe have covered so many topics over the past two seasons — from automated system best practices such as validating your cloud solutions and maintaining data integrity, to various best practices areas like inspection readiness and global inspection trends; as well as current hot topics. For new listeners, this could be a great episode to tune into to find out which episodes you want to go back and listen to next!   So sit back, relax, and enjoy this episode dedicated to all of you — Automating Quality's listeners!   Key Takeaways: [:32] Mandy opens up today's episode by thanking guests and listeners for tuning in for the past two seasons! [1:54] Philippe thanks Mandy, the guests, and listeners of Automating Quality, and reminisces on their podcast journey. [3:23] About today's special 'best of' episode! [4:42] In this first clip, Rachel Fountain speaks about implementing a change management process from episode 1. [5:29] Jay Turner speaks about optimizing compliance from episode 2. [5:55] In this episode 3 clip, Mary Senica speaks about evaluating and implementing a software solution. [6:38] Alan Greathouse speaks about measuring operational effectivenes...

Episode 30: Inspection Readiness from a GCP and GMP Lens with Nathalie Bourgouin

29 min

Welcome to the 30th 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 all about inspection readiness and distinguishing what that looks like from both the GMP side and the GCP side. And joining Mandy today is return guest, Nathalie Bourgouin! Nathalie is the Vice-President of Compliance at Skillpad — a sister company of SOLABS — where she leads the Compliance Consulting Group, with a focus on clinical trials and research compliance. She's a very well-rounded, highly experienced expert in the space with more than 25 years of experience in pharmaceuticals and biotech!    In this episode, Nathalie highlights the key concepts regarding GxP inspection readiness, compares the differences between GMP and GCP inspection readiness programs, explains how a company can better prepare for an inspection, and even highlights some of the issues she often sees coming up in inspections.   Whether you are new to the life sciences space or are a veteran with many years of experience, you will gain something of value in today's episode!   Key Takeaways: [:28] About today's episode! [2:35] Mandy welcomes Nathalie to the podcast! [2:46] Nathalie highlights key concepts regarding GxP inspection readiness. [4:14] Nathalie compares GMP vs. GCP inspection readiness programs. [5:05] How can a company get ready for an inspection? [7:59] Nathalie highlights some of the issues that she commonly sees coming up in GMP regulatory inspections. [12:42] How GCP inspections differ from GMP inspections as well as some of the key differences in the inspection process between the United States and Canada. [18:59] Nathalie provides some key tips for preparing for an inspection. [21:23] Nathalie's tips for preparing individuals on your team for an inspection. [24:45] Nathalie stresses the importance of identifying who your key people will be for the in...

Episode 29: Data Migration and Data Integrity with Philippe Gaudreau

33 min

Welcome to the 29th 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 is a really fun episode! Mandy is joined by her co-host, founder and CEO of SOLABS, Philippe Gaudreau. And they're partnering together in this episode to discuss data migration as it relates to data integrity.   This topic has risen to the top in relevancy in the GMP world, so today, Mandy and Philippe will be highlighting some of the best practices and strategies to consider when implementing these key concepts into your organization!   Mandy explains the link between data migration and data integrity; defines the concept of data migration and the key phases that should be considered for inclusion when developing a migration strategy; and then, from a regulatory compliance perspective, highlights what must be considered with regards to data migration. Later on, Philippe explains what has changed in the data migration area over the years and suggests methods for creating efficient migration projects.   Key Takeaways: [:28] About today's special episode! [2:50] Jumping right into it, Philippe first asks Mandy to describe the importance of data migration in the Life Sciences space and to define the key phases of data migration. [9:24] Mandy explains the link between data migration and data integrity. [13:29] From a regulatory compliance perspective, what must be considered with regards to data migration? [15:27] Philippe explains what has changed in the data migration area over the years from his perspective. [18:55] Philippe suggests methods to create efficient migration projects. [23:56] What are the international standards related to data migration? [26:18] What are some qualification approaches and strategies to ensure data integrity? [29:32] Mandy shares a personal experience with data migration processes. [30:23] Mandy wraps up this week's episode and...

Episode 28: Regulatory Convergence and Its Impact on the Life Sciences Industry

13 min

Welcome to the 28th 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 all about regulatory convergence! In the world of globalization, it makes sense that we're finally starting to see extensive shifts in philosophy and regulations as they apply to the Life Sciences industry, which are setting new quality standards for drug and device manufacturers. It's a very exciting topic as there have been some incredibly notable changes in the last 5 years!   In this episode, Mandy will be highlighting some of the key pieces to consider when thinking about the concept of regulatory convergence and explains how it is driving extensive shifts in the Life Sciences space.   Key Takeaways: [:28] About today's episode. [1:00] Mandy explains what the term 'regulatory convergence' refers to. [2:38] What is the Mutual Recognition Agreement (MRA) and how is it related to the concept of regulatory convergence? [5:22] Mandy highlights some of the key benefits impacting public health that stem from regulatory harmonization. [8:25] Mandy speaks about the two major international standard bodies that are playing a vital role in regulatory harmonization (or convergence) and highlights the technical areas that they are affecting. [12:59] Mandy wraps up this week's episode and thanks listeners for tuning in!   Mentioned in this Episode: World Health Organization (WHO) The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Mandy.Podcast@Solabs.com

Episode 27: The LIR Process and Key Considerations for Robustness with Kathryn Landes

26 min

Welcome to the 27th 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 on the podcast, Mandy is bringing you a topic that has yet to be discussed in-depth on the show, and that is Laboratory Investigation Reports (also known as LIRs) and critical elements to consider when designing or implementing enhancements to the quality management process. Ensuring that your LIR process is robust is critical to your business operation and will help set you up for success if scrutinized during an inspection. All-in-all, it is a key part of the QMS.     Joining Mandy today is Life Sciences veteran and Quality expert, Kathy Landes, to provide expert feedback on this topic! Kathryn has more than 20 years of experience and is an absolute wealth of knowledge in this space! As someone who has spent many years developing and managing QC laboratories as part of her career as a quality professional and knows the LIR process inside and out, Kathy sheds light on some of the key areas to consider, breaks down some of the processes to their fundamental parts, and highlights many important considerations related to LIR.   Key Takeaways: [:30] About today's episode. [1:22] Mandy welcomes Kathryn Landes to the podcast! [1:57] Kathryn gives an overview of her background in the Life Sciences space. [4:10] What is the intent of the LIR process? And what are the key elements that must be included as part of a robust process? [8:13] What are some common issues or barriers related to the LIR process that are often scrutinized by regulatory agencies? [14:27] Kathryn recommends some best practices for companies that are new to implementing this process as part of their QMS infrastructure as well as those who are focused on improving their existing process. [19:22] What steps should be taken when the root cause of an issue cannot be pinpointed through the LIR process...

Episode 26: Current Hot Trends in the Medical Device Industry

16 min

Welcome to the 26th 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 show is focusing on a topic that has yet to be discussed on the show thus far, and that is the medical device industry and current hot trends from a regulatory perspective! Automating Quality has taken a look at regulatory trends from a broader perspective, but this is the first time they will be diving deep into the current happenings in the device space.    This episode will shed light on some key areas in FDA shift and focus; provide information on innovating trends that are transforming this niche; as well as changes to medical device regulations, setting new precedents that the industry is being held accountable for adopting.   Key Takeaways: [:29] About today's episode! [1:20] Mandy explains how the FDA is using science to help innovate and accelerate the medical device industry, as well as why the FDA is so invested in pioneering enhancements to this specialized area of the life sciences industry. [3:30] The context of use on MDDT tools. [4:30] The types of categories that fall under the MDDT Program and how these categories are assessed. [7:55] Have new regulations been implemented that impact the medical device manufacturers? [10:52] Mandy explains some of the key impacts of these new regulations. [15:02] Mandy thanks listeners for tuning in! [16:10] If you have any questions or suggestions for future episodes, you can contact Mandy at Mandy.Podcast@Solabs.com.   Mentioned in this Episode: FDA MDDT Program Mandy.Podcast@Solabs.com

Episode 25: How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil Becker

31 min

Welcome to the 25th 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 all about leveraging a risk-based approach to develop, implement, and maintain your IT programs, extending to GxP controls and critical infrastructure. Guest industry expert, Phil Becker, will be joining Mandy today to discuss this topic and to provide guidance!   Phil has over 30 years of experience in the IT field. He's an industry thought leader who's held various strategic leadership roles, including Vice President of IT at Acculogix and Fisher Clinical Services, where he was Chief Architect and Developer of the first truly integrated 21 CFR part 11 compliant electronic batch record in the pharmaceutical supply industry. Phil has also developed the industry's first web-based reporting software integrated solution. His vast experience in the space includes software application development, architecture, design for manufacturing, and regulatory compliance.   With Phil's extensive background in the IT space and pharmaceutical arena, he will be providing some incredible guidance on what listeners should consider in terms of IT controls, which risk management tools and approaches you should be taking a look at, and other tactical considerations that will help with the developments and enhancements of your IT program and critical process controls.   Key Takeaways: [:35] About today's episode. [1:50] Mandy welcomes Phil to the podcast! [2:49] How can a risk-based approach be leveraged to develop and implement an IT control strategy to support GxP business systems? [7:52] What are some risk management tools and approaches that are effective to assess the types of critical controls and the level of robustness that's appropriate for business systems? [17:47] In regards to business continuity, what are some of the key inputs that should be considered for...

Episode 24: All About the Quality Risk Management Lifecycle

23 min

Welcome to the 24th 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 focusing on quality risk management — the process for systematically identifying, assessing, and controlling risk to the quality of pharmaceutical products across the product lifecycle. Although the Automating Quality Podcast talks about risk quite often, this episode will be specifically zoning in on the concept of quality risk management (or QRM), how it is implemented, the four key phases that define the QRM lifecycle, and many other important additional elements. Mandy Gervasio will be breaking down this topic in today's solo's episode, highlighting the most foundational key elements of QRM!   Listeners that are new to the industry and veterans alike will get plenty of value from today's episode. So be sure to tune in to brush up on the fundamentals of leveraging a QRM methodology!   Key Takeaways: [:30] About today's episode. [1:35] What is QRM? And where is this methodology most often leveraged? [4:23] How is QRM implemented? And what are some key benefits? [5:26] How ICH Q9 has impacted the pharma industry, as well as transformed past precedences. [10:40] Mandy outlines the four key phases that define the QRM lifecycle. [14:31] Mandy highlights an important element to the QRM lifecycle: risk communication. [16:02] How ICH Q9 has been the catalyst for a significant paradigm shift in traditional GMP processes and benchmark standards. [20:05] Mandy wraps up the episode by summarizing what QRM is. [20:43] What to look forward to in future episodes! [21:09] Mandy thanks you all for tuning in for this week's episode. If you want to get in touch with her, you can contact her at Mandy.Podcast@Solabs.com.   Mentioned in this Episode: Quality Risk Management (QRM) Quality by Design (QBD) ICH Q9 Mandy.Podcast@Solabs.com

Episode 23: Innovation to Retrovation: Maintaining GTP in a GxP World, with Jay Turner

32 min

Welcome to the 23rd 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, Mandy is joined by her co-host, Philippe Gaudreau, and return guest from episodes two and ten, Jay Turner! Jay is the CEO and founder of EduJay LLC., and he is a self-proclaimed learning and development ninja! He has devoted his career to improving people, processes, and programs to produce business results. This includes everything from implementing learning management systems, to designing staff development and leadership development programs, to providing executive coaching.   In this episode, Mandy and Jay are discussing innovation to retrovation — an interesting concept about maintaining GTP (AKA Good Training Practices) in a GxP world. Jay gives his expert feedback on the concepts of GTP, explains what he means by "retrovate" and how it applies to training, gives his top three favorite GTPs and how they can be leveraged in the quality space, and also explains how we can effectively innovate in training when we know it's needed. The feedback that Jay provides in this episode will be incredibly beneficial for listeners who are considering enhancements to their current training and professional development programs. So tune in to get all of his valuable insight on today's topic!   Key Takeaways: [:32] About today's episode with return guest, Jay Turner! [2:37] Mandy welcomes Jay back to the show! [2:49] What does Jay mean by "retrovate" and how does it apply to training? [7:12] Jay lists his top two out of three GTPs and how they can be leveraged in the quality space. [14:20] Jay speaks about moving beyond required training and empowering staff members to become a part of the learning function in the organization. [17:50] Jay explains his third favorite GTP. [21:26] How can we effectively innovate in training when we know it's needed? [28:07] Mandy thanks...

Episode 22: Justin Lacombe on Quality by Design

26 min

Welcome to the 22nd 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!   This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Justin Lacombe. Justin has a depth of experience in pharmaceutical development and implementing methodologies founded in Quality by Design (QbD). He is a Chemical Engineer and got his PhD in Chemical Engineering from Rutgers University. He has been spending the past 12 years in the inhalation part of life sciences and pharmaceutical development. He has gotten involved in the area of QbD in the last 4-5 years to try and understand how they can better their development on their products at Experic, where he serves as Director of Pharmaceutical Development and Manufacturing Services.   Today they are going to be discussing Quality by Design — a really important and hot topic in pharmaceuticals! In the past decade, there has been rapid adoption of QbD on the pharmaceutical side of the life sciences industry. So tune in to learn all about what QbD is, what the overall process looks like, the phases and approach of a formalized QbD process from a pharmaceutical development perspective, the relationship between QbD and experimental design, how QbD can help design an effective product development plan, and much more.   Key Takeaways: [:14] About today's episode. [1:49] About today's featured guest, Justin Lacombe. [2:08] Justin introduces himself and gives some background about his career. [4:05] Justin explains what QbD is and what the overall process looks like. He then goes a bit deeper, explaining the phases and approach of a formalized QbD process from a pharmaceutical development perspective. [9:01] Justin explains the relationship between QbD and experimental design, and how this all ties into controlled strategy for manufacturing. [15:18] Justin outlines how critic...

Episode 21: Michael de la Torre on GMP Inspection Analytics

26 min

Welcome to the 21st 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!   This week, Mandy is joined by her co-host, Philippe Gaudreau, the CEO of Solabs, as well as their guest, Michael de la Torre. Michael is Chief Executive Officer of Govzilla — the leading platform for GxP inspection analytics. As a company, they are leveraging the power of Big Data and Machine Learning to make government data accessible, usable, and valuable to everyone who needs it.   As the life sciences industry continues to evolve, with regulatory compliance remaining a critical factor for success, inspection trends are a tool to help companies to develop and enhance their quality management systems. Additionally, being aware of these current trends is a key factor for developing a robust audit readiness program. If you or your industry colleagues are seeking a good tool to enhance your understanding of inspection trends, you do not want to miss this week's episode!   Key Takeaways: [:29] About today's episode. [1:20] Michael introduces himself, his expertise background, and his company, Govzilla. [3:29] Michael speaks about the most important recent FDA inspection and enforcement trends. [7:49] What are the top items cited by the FDA in human drugs? And have there been any changes in the last couple of years? [12:22] Michael speaks about changes in the inspection scope since the issuance of the data integrity guidance in 2018. [16:11] Michael's take on Cloud-based solutions for the life sciences industry. [18:15] What impact has the FDA had on the market with their efforts on being more open and transparent with their inspections and enforcement data? [22:53] How Govzilla could be incredibly useful for your organization! [23:18] Mandy and Philippe thank Michael for joining them this episode. [25:02] How to get in touch with Michael de la Torre and Mandy Gervas...

Episode 20: Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting

33 min

Welcome to the 20th 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!   This week, Mandy is wrapping up the six-part series focused around quality culture, the virtual pharma environment, and supply chain management; with Lisa Helmonds, the Vice President of MWA Consulting. She is also joined by her co-host, Philippe Gaudreau, the CEO of Solabs.   In this week's episode, they discuss investigation deviations and non-conformances. Lisa provides many excellent tips to keep in mind as you become familiar with the investigation and deviation management process. These tips will surely help listeners enhance their quality programs! This is a wealth of information for those new to the industry and veterans alike!   This episode officially wraps up the six-part series with Lisa Helmonds! Be sure to subscribe to the podcast for more great episodes on quality management.   Key Takeaways: [:22] About today's episode. [1:22] Lisa Helmonds introduces herself and provides some background on her career. [2:40] About today's topic: investigation deviations and non-conformances. [3:21] Why are investigations of deviations and non-conformances so important in the industry? [4:52] Are these investigations required by regulatory agencies or voluntary? [5:57] Is there a difference between a deviation and a non-conformance? [9:50] What is a root cause analysis? [10:12] Tools that can be used in the investigation and the root cause analysis process. [12:23] What do you do after the root cause is identified? [18:17] What a full investigation report entails. [22:46] What constitutes a well-written investigation report. [27:00] From an audit perspective, what do investigators looks for during inspection regarding deviations? [29:08] Mandy recommends further listening. [30:17] Mandy thanks Lisa for joining her for this six-part series. [31:41] Mandy reca...

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