FDA Inspection Masterclass

FDA Inspection Masterclass: Insider Guidance from a Former FDA Investigator

Get exclusive, behind-the-scenes insight into how FDA inspections really work—taught by someone who conducted them for over a decade.

This video masterclass delivers essential knowledge for pharmaceutical and biotech companies looking to ace FDA inspections, avoid costly enforcement actions, and ensure long-term compliance.

What You’ll Learn:

• How FDA investigators are trained to think—and what they’re really looking for
• The 3 biggest mistakes companies make (and how to avoid them)
• The difference between a 483, Warning Letter, and Consent Decree—and how to avoid all of them
• Practical, proven strategies to prepare your team, documents, and systems before the inspector shows up
• Real-world examples from inspections of API, oral solid dose, biologics, and sterile facilities
• Knowledge assessment (quiz) and certificates! ($10/person upon completing the test. Pay separately via PayPal. Contact devaughn@fdaid.org with participant name(s) and a PayPal invoice will be forwarded.

Who This Is For:

• Quality Assurance & Compliance professionals
• Manufacturing & Operations leads
• Regulatory Affairs teams
• Consultants and auditors
• Anyone who wants to be inspection-ready—before the knock at the door

Length: 43 minutes
Format: On-demand video (watch anytime)

"This course completely changed how we prepare for inspections. DeVaughn’s insider perspective as a former FDA Investigator gave us the confidence to revamp our entire audit readiness strategy. I would recommend this to anyone serious about compliance."

— Anita K., QA Director, Pharmaceutical Company (USA)

"Even after participating in multiple FDA inspections over my career, I learned critical new strategies in this masterclass. The real-world examples and step-by-step breakdowns made it easy to apply immediately. Every QA team should take this course."

— Rajesh P., Senior Manager, Quality Systems (India)

"I was completely overwhelmed thinking about our upcoming FDA inspection. After taking this course, I had a clear plan, knew exactly how to set up our front room and back room teams, and felt 100% more prepared. Absolutely worth every penny."

— Lily M., Regulatory Affairs Specialist (Australia)

"This masterclass is not just training — it’s a survival manual. DeVaughn doesn’t just teach the regulations; he shows you exactly what Investigators look for, what triggers citations, and how to stay in control. Outstanding course."

— Carlos S., QC Laboratory Manager (Brazil)

"The FDA Inspection Masterclass gave our leadership team the tools we needed to tighten our compliance program before the audit season. DeVaughn’s knowledge is unmatched, and the examples from real inspections made the training extremely practical."

— Elena D., Head of Quality Assurance (Germany)