# 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. --- ![1756829998899.jpeg](https://storage.googleapis.com/gks-blog-images/blog-images/d0555d45f02a4a2fb2cb65935c0df128.jpeg) **Access the recording by viewing our [webinar recap](https://mailchi.mp/8ce82220bec3/subscriber-newsletter-latest-updates-just-for-you-243) and claiming the [Zoom recording or slides](https://mailchi.mp/8ce82220bec3/subscriber-newsletter-latest-updates-just-for-you-243).** --- ## Speakers ### Thank you to our Speakers: ### [Bill Levinson](https://www.linkedin.com/in/williamalevinson/) ![1516307014067.jpg](https://storage.googleapis.com/gks-blog-images/blog-images/fa7ebe2ac2e3441ba682853f373ed1cd.jpg) > “A very large proportion of warning letters arise from failure to take corrective and preventive action.” > > “Prevention is better than detection.” ### [Daniel Barreto](https://www.linkedin.com/in/daniel-barreto-021827b4/) ![1732291102966.jpg](https://storage.googleapis.com/gks-blog-images/blog-images/04065c95d65346528ebf4b8ccd058c47.jpg) > “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.” ### [Ligia Zubik, Ph.D., ASQ-CQA](https://www.linkedin.com/in/ligia-zubik/) ![1740453704044.jpg](https://storage.googleapis.com/gks-blog-images/blog-images/419bf1c6d0a446d28399be0bd19b2f8a.jpg) --- ## What’s next - **September Warning Letter Wednesday**, Decoding FDA Warning Letters: Keywords, Analysis & Insight - [Register Here](https://luma.com/fgucwsan) : [https://luma.com/fgucwsan](https://luma.com/fgucwsan) - See you at **ISPE Boston Product Show** on Oct 1. - Follow us on Linked-In: [https://www.linkedin.com/company/globalkeysolutions/](https://www.linkedin.com/company/globalkeysolutions/) --- ### Want to be part of future webinars or have questions? - **Contact**: hello@globalkeysolutions.net