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!

Avsnitt(63)

Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin

Episode 39: Clinical Inspection Readiness: The Closing Phase with Nathalie Bourgouin

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...

7 Juli 202021min

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

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

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 epi...

9 Juni 202036min

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

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

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...

31 Mars 202017min

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

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

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...

17 Mars 202025min

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

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

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 sh...

3 Mars 202020min

Episode 34: Artificial Intelligence from a Life Sciences' Perspective

Episode 34: Artificial Intelligence from a Life Sciences' Perspective

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 we...

18 Feb 202023min

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

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

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...

4 Feb 202037min

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

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

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 ep...

21 Jan 202026min

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