GKS August Warning Letter Wednesday Recap

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.

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

• September Warning Letter Wednesday, Decoding FDA Warning Letters: Keywords, Analysis & Insight

• Register Here : https://luma.com/fgucwsan

• See you at ISPE Boston Product Show on Oct 1.

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