What to expect in an FDA Inspection: Compliance Program Guidance Manuals

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What to expect in an FDA Inspection: FDA’s Compliance Program Guidance Manuals

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Presenter: Cindy Lipton, Quality Assurance Consultant, MWA Consulting, Inc.

Understanding FDA’s expectations during an inspection is key to inspection readiness and maintaining a state of control for all your operations that are subject to the Federal Food Drug and Cosmetic Act (FFDCA) and the Public Health Service Act (PHSA) and the regulations and rules in place to enforce these Federal Laws.

The FDA performs risk-based inspections for products in development and those on the commercial market, whether they are manufactured in-house or outsourced to CMOs. FDA inspections ensure products comply with cGMP and that reliable data are submitted to demonstrate that drugs and devices are safe and effective.

The FDA has published CPGMs (Compliance Program Guidance Manuals) for FDA Inspectors to follow when conducting inspections of Drug and Device establishments

MWA Consulting will provide an overview of these manuals, where to find them and how to use them to prepare for FDA inspections of your facility or operations.

About the Presenter: During her over 20 years of experience in a regulated industry in small and large company settings, Cindy Lipton has managed Quality Systems development and implementation. In virtual company settings, Cindy implemented vendor management and audit programs. She has led the QA/QC functions for pharmaceutical development and manufacturing and has hosted FDA and various Health Authority inspections.

January 15, 2020 10:30 AM to 12:00 PM, One hour presentation followed by Q&A.

Dial-in number (US): (605) 313-5425

Access code: 261791#

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meeting ID: cindylipton

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