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51
Automating Quality

SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests

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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 ...
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Episode 55: Inspection Readiness Strategies with Caroline Guay-Adam 15:19

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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, we discuss a topic key to the heart of most quality professionals: inspection readiness! Our guest Caroline Guay-Adam discusses inspection readiness and how to reach and maintain an inspection-ready …
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Episode 54: Risk Management Tools and Techniques with Michael Tyo 15:32

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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo joins Philippe Gaudreau in a discussion on risk management tools. They discuss the importance of a risk plan and a risk assessment SOP, plus the FDA’s expectations regarding the use…
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Episode 53: Leveraging the FDA's Warning Letters with Michael Tyo 18:35

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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. In this episode, guest Michael Tyo discusses how warning letters can be leveraged as a source of information on the FDA’s current areas of focus and how monitoring them can help avoid the FDA’s attention. Key Takeawa…
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Episode 52: Supplier Quality Management w. Mandy Gervasio 17:28

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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS, and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma. In this episode, Mandy and Philippe discuss supplier management from establishing a relation…
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Episode 51: Takeaways from 2023 Quality Conferences with Mandy Gervasio 20:30

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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. This show is hosted by Philippe Gaudreau, CEO at SOLABS and Mandy Gervasio, VP of QA and Compliance at Comanche Biopharma. In this episode, we explore Mandy’s takeaways from recent quality conferences she attended, f…
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Episode 50: Analytics for GMP Floor Environment with Jamie Villeneuve 16:06

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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this very special 50th episode! We are joined today by Jamie Villeneuve, CEO and Head of Software Development at NexGen Analytics. Jamie will discuss the common chall…
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Episode 49: Designing Analytics for the Life Sciences Industry with Jamie Villeneuve 16:07

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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! We are joined today by Jamie Villeneuve, Owner and Head of Software Development at NexGen Analytics. Jamie will discuss the design of analytics from est…
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Episode 48 - Supplier Management Quality for the Medical Devices Industry with Joseph Silvia 14:18

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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! We are joined today by return guest Joseph Silvia, Director, Software Quality Training, and Instructor at Oriel STAT A MATRIX. In this episode, Joe shar…
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Episode 47 - Overview of the Draft Guidance for Computer Software Assurance with Joseph Silvia 19:02

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Welcome to Automating Quality, the Life Sciences centric show that bridges the gap between automation and quality management systems. Philippe Gaudreau, CEO at SOLABS is your host for this episode! Our guest today is Joseph Silvia, Director, Software Quality Training and Instructor at Oriel STAT A MATRIX. Joe shares his expertise on the Case for Qu…
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Episode 46 - Defining Data Quality with Steve Gens 17:38

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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features Steve Gens, Managing Partner at Gens & Associates. We will define data quality, what happens if the confidence in data quality is low, and provide some recom…
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Episode 45 - The World Class RIM Benchmark by Gens & Associates Featuring Steve Gens 22:36

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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today's episode features Steve Gens, Managing Partner at Gens & Associates. We will discuss the World Class RIM Benchmark conducted by Gens & Associates, how it came into being, and …
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Episode 44: Good Machine Learning Practices for the Medical Devices Industry with Ben Locwin 15:36

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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. A…
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Episode 43: Artificial Intelligence and Machine Learning in the Medical Devices Industry with Ben Locwin 20:44

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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. A…
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Episode 42: Gens & Associates' Quality Benchmark with Katherine Yang-Iott 25:46

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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! In today’s episode, we will discuss the discoveries of the Quality Benchmark conducted by Gens & Associates in late 2021. Our guest today is Katherine Yang-Iott. She is a consultant …
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Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin 18:22

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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features guest expert Ben Locwin! Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry for over 25 years. A…
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Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin 22:01

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Welcome to Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode features a conversation with guest expert Ben Locwin. Ben is the VP of Project Solutions at Black Diamond Networks and has been working in the life sciences industry …
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#pertanyaanpsikolohih starring Tante Mona ❤💋🔥 - Ep. 1 18:29

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"Haiii sayang 🔥💋❤, #tantemona di sini. Silakan #pertanyaanpsikolohih -nya" . Tante-tante satu ini adalah paporit kengkawan handai taulan, penuh empati, getar, gelora. Sampaikan #pertanyaanpsikolohih kalian via IG @masbrmntyo dan Tante Mona akan menjawab penuh getar membahana. Salam sayang 🔥💋❤
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Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin 21:02

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Welcome to the 39th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! In today’s episode, Mandy Gervasio and Nathalie Bourgouin (the Vice President of Compliance at Skillpad), are continuing on the topic of clinical inspection readi…
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Episode 38: Data Integrity and Data Governance in a Remote Work Environment with Ben Locwin 36:07

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Welcome to the 38th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! Today’s episode is a little different than usual. Philippe Gaudreau will be joining Mandy as a co-host in a conversation with guest expert Ben Locwin. Ben is the …
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Episode 37: Clinical Inspection Readiness: the Execution and Monitoring Phase with Nathalie Bourgouin — Part 3 17:19

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Welcome to the 37th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! In today’s episode, Mandy Gervasio and Nathalie Bourgouin (the Vice President of Compliance at Skillpad), are continuing last week’s topic on clinical inspection …
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Episode 36: Clinical Inspection Readiness: the Planning Phase with Nathalie Bourgouin — Part 2 25:31

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Welcome to the 36th episode of Automating Quality. Mandy Gervasio is your host, and she’s on a mission to bring you hot industry topics with her fellow life sciences partners and friends! On today’s episode of Automating Quality, Mandy Gervasio and Nathalie Bourgouin, the Vice President of Compliance at Skillpad, are continuing last week’s topic on…
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Episode 31: Guest Tribute Show: ‘Best of’ Moments from the Last Two Seasons! 27:45

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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…
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Episode 30: Inspection Readiness from a GCP and GMP Lens with Nathalie Bourgouin 29:52

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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 retu…
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Episode 29: Data Migration and Data Integrity with Philippe Gaudreau 33:04

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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 di…
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Episode 28: Regulatory Convergence and Its Impact on the Life Sciences Industry 13:57

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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 philosop…
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Episode 27: The LIR Process and Key Considerations for Robustness with Kathryn Landes 26:43

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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…
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Episode 26: Current Hot Trends in the Medical Device Industry 16:52

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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 regul…
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