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January 2025

Developing and Retaining an Engaged Workforce with Astellas Pharma's VP & Head of Quality Systems, Jill O'Mullane
A few actionable strategies for boosting employee engagement, development, and retention in 2025.
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The FDA Group
46:45
A Few Quick Tips for CAPA System Success in 2025
CAPA remains a top compliance concern year after year — one we see all the time in audits. Here are five practical steps you can take right now to…
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The FDA Group
When the QA Manager Leaves: A 5-Month Staff Augmentation Success Story
When a QA manager's sudden departure left critical systems in disarray, one experienced consultant stepped in to rebuild vendor management, implement…
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The FDA Group
RA/QA News Roll: Mid January 2025
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
The FDA Just Released a Ton of Guidance Documents
The agency is kicking off 2025 with a trove of new guidance just weeks before the new administration takes over. Here's a handy reference to what just…
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The FDA Group
Guidance Breakdown: The FDA Updates its GUDID Final Guidance
The update makes minor revisions from the previous 2014 guidance, including the removal of now-unneeded FDA Preferred Terms or codes from the database…
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The FDA Group
RA/QA News Roll: Late December 2024
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group

December 2024

[December 2024] Nitrosamine Control, Device Remanufacturing + Warning Letter Analysis
Watch now (17 mins) | This month we examine the FDA's evolving stance on pharmaceutical impurity controls and device remanufacturing requirements, while…
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The FDA Group
16:41
RA/QA News Roll: Mid December 2024 ❄️
Here's what's happening at FDA and across the broader life science RA/QA space.
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The FDA Group
Are You Ready for Your Next Data Integrity Audit?
Here's what our auditors look for and how to assess your own readiness heading into 2025.
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The FDA Group
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