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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Episode 63 - Qualification of Software Vendors with Masha Ivankovic (00:16:13)
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 (00:23:55)
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 (00:27:07)
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 (00:18:34)
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 (00:18:31)
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 (00:15:12)
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 (00:16:36)
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 (00:18:08)
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 (00:15:19)
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 (00:15:32)
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 (00:18:35)
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 (00:17:28)
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 (00:20:30)
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 (00:16:06)
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 (00:16:07)
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 (00:14:18)
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 (00:19:02)
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 (00:17:38)
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 (00:22:36)
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 (00:15:36)
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 (00:20:44)
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
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 (00:18:22)
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 (00:22:01)
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 (00:21:02)
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
