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 [email protected]

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!

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

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

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 [email protected]

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

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

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

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