SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests

Automating Quality

Science EN ↓ 66 episodes

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.

Author

SOLABS, Mandy Gervasio, Philippe Gaudreau, and Guests

Episodes

Episode 41: Framework for the FDA's Real-World Evidence Program with Ben Locwin 02.08.2022 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...

Episode 40: What are Real-World Data and Real-World Evidence? With Ben Locwin 12.07.2022 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 trai...

Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin 07.07.2020 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-par...

Episode 38: Data Integrity and Data Governance in a Remote Work Environment with Ben Locwin 09.06.2020 36:07

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 i...

Episode 37: Clinical Inspection Readiness: the Execution and Monitoring Phase with Nathalie Bourgouin — Part 3 31.03.2020 17:19

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 f...

Episode 36: Clinical Inspection Readiness: the Planning Phase with Nathalie Bourgouin — Part 2 17.03.2020 25:31

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...

Episode 35: Clinical Inspection Readiness: the Initial Stage with Nathalie Bourgouin — Part 1 03.03.2020 20:14

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...

Episode 34: Artificial Intelligence from a Life Sciences' Perspective 18.02.2020 23:36

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...

Episode 33: Case Study for Implementing an EQMS from a System Owner's Lens 04.02.2020 37:21

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 i...

Episode 32: Major Trends in Automation for the Life Sciences Industry in 2020 21.01.2020 26:08

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...

Episode 31: Guest Tribute Show: 'Best of' Moments from the Last Two Seasons! 10.12.2019 27:45

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...

Episode 30: Inspection Readiness from a GCP and GMP Lens with Nathalie Bourgouin 26.11.2019 29:52

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...

Episode 29: Data Migration and Data Integrity with Philippe Gaudreau 12.11.2019 33:04

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 int...

Episode 28: Regulatory Convergence and Its Impact on the Life Sciences Industry 16.10.2019 13:57

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 S...

Episode 27: The LIR Process and Key Considerations for Robustness with Kathryn Landes 02.10.2019 26:43

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 c ritical elements to consider when...

Episode 26: Current Hot Trends in the Medical Device Industry 04.09.2019 16:52

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 take...

Episode 25: How to Leverage a Risk-Based Approach to Develop, Implement, and Maintain Your IT Programs, with Phil Becker 06.08.2019 31:31

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, wi...

Episode 24: All About the Quality Risk Management Lifecycle 09.07.2019 23:21

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. Alth...

Episode 23: Innovation to Retrovation: Maintaining GTP in a GxP World, with Jay Turner 25.06.2019 32:39

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...

Episode 22: Justin Lacombe on Quality by Design 11.06.2019 26:33

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 methodol...

Episode 21: Michael de la Torre on GMP Inspection Analytics 21.05.2019 26:02

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 inspe...

Episode 20: Investigation Deviations and Non-Conformances with Lisa Helmonds Vice President from MWA Consulting 07.05.2019 33:44

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...

Episode 19: Management Review and Quality Metrics with Lisa Helmonds from MWA Consulting 23.04.2019 24:39

Welcome to the 19th 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 bringing you the fifth part of the six-part series focused around quality culture, the virtual pharma environment, and supply chain management. As always, she is joined by her veteran guest o...

Episode 18: Quality Culture with Lisa Helmonds from MWA Consulting 26.03.2019 21:57

Welcome to the 18th 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! Mandy is excited to bring you the fourth part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space! As a reminder, Lisa is the Vice President of MWA Consulting and has o...

Episode 17: Quality Agreements with Lisa Helmonds from MWA Consulting 12.03.2019 27:44

Welcome to the 17th 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 will be the third part in the six-part series with Lisa Helmonds about virtual companies in the life sciences space. Lisa is the Vice President of MWA Consulting and has over 30 years of industrial traini...