Global Key SolutionsWebinar
GKS August Warning Letter Wednesday Recap
By Dr. Ligia Zubik, Zephaniah Odidika · Published September 2, 2025
https://www.keypedia.com/media/c7908633-f40a-4c9b-97f7-3623d2f0250d
Webinar
GKS August Warning Letter Wednesday Recap
By Dr. Ligia Zubik and Zephaniah Odidika
September 2, 2025
GKS August Warning Letter Wednesday Recap
Summary (TL;DR)
- Prevention & Correct: robust CAPAs and a living FMEA are crucial to fewer 483s and Warning Letters.
- Inspection lifecycle: Deep coverage of the FDA inspection lifecycle.
- GKS eLibrary: Updates on trend citations,mapping keywords & violation codes, and turning insights into leadership-ready KPIs.
Access the recording by viewing our webinar recap and claiming the Zoom recording or slides.
Speakers
Thank you to our Speakers:
“A very large proportion of warning letters arise from failure to take corrective and preventive action.”
“Prevention is better than detection.”
“Even when companies don't get a 483, that doesn't necessarily mean the company is actually in good shape.”
“If you did not provide an adequate response… There is a very high probability that you'll be issued a warning letter.”
What’s next
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September Warning Letter Wednesday, Decoding FDA Warning Letters: Keywords, Analysis & Insight
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See you at ISPE Boston Product Show on Oct 1.
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