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

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

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!

Episoder(63)

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

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

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, s...

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

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

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 e...

26 Nov 201929min

Episode 29: Data Migration and Data Integrity with Philippe Gaudreau

Episode 29: Data Migration and Data Integrity with Philippe Gaudreau

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 ...

12 Nov 201933min

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

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

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 e...

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

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

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 ...

2 Okt 201926min

Episode 26: Current Hot Trends in the Medical Device Industry

Episode 26: Current Hot Trends in the Medical Device Industry

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 s...

4 Sep 201916min

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

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

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 ep...

6 Aug 201931min

Episode 24: All About the Quality Risk Management Lifecycle

Episode 24: All About the Quality Risk Management Lifecycle

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 ep...

9 Jul 201923min

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