Global Key SolutionsWebinar
May Warning Letter Wednesday
By Dr. Ligia Zubik, George Kwiecinski, Zephaniah Odidika · Published May 30, 2025
https://www.keypedia.com/media/may-warning-letter-wednesday/
Webinar
May Warning Letter Wednesday
By Dr. Ligia Zubik, George Kwiecinski and Zephaniah Odidika
May 30, 2025
Discuss this article with AI
May Warning Letter Wednesday Recap
Data Integrity & Validation
Hosted by Global Key Solutions
Featured Speakers
(Left)Dr. Ligia Zubik and (Right)Robert Perks, Director of Digital Solutions, Performance Validation.
Focus Topic: Data Integrity and Validation
May’s session focused on rising enforcement around data integrity violations and validation failures. With increasing regulatory scrutiny on digital systems, teams must prioritize readiness.
Covered in the session:
- FDA expectations on data controls and audit trails
- Best practices for computer system validation (CSV)
- Examples from recent FDA Warning Letters
- Strategies to improve inspection readiness
Presented as part of our monthly Warning Letter Wednesday series on FDA regulatory trends and compliance strategy.
© Global Key Solutions · globalkeysolutions.net · Printed July 21, 2026
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