Dublin, Nov. 06, 2026 (GLOBE NEWSWIRE) -- "FDA Inspections: What to Expect, How to Prepare & Avoid 483 Observations (May 13th - May 14th, 2026)" has been added to ResearchAndMarkets.com's offering.
Research and Markets has made the recording of “FDA Inspections: What to Expect, How to Prepare & Avoid 483 Observations” available for on-demand purchase. The course, led by course provider Kelly Thomas, was held live on May 13-14, 2026. It prepares organisations for pre-approval, routine GMP and for-cause inspections, and shows how to respond effectively when findings are issued.
Key Event Facts
- Course: FDA Inspections: What to Expect, How to Prepare & Avoid 483 Observations
- Format: Recorded training, accessed online through a secure website
- Original live event: May 13-14, 2026 (EST)
- Duration: Two days, 10 hours of continuing education
- Certificate: Certificate of Completion
- Course provider: Kelly Thomas
Day 1: Inspection Readiness and Compliance Fundamentals
The first day sets out the FDA’s inspectional authority, the legal basis for inspections, and what is within the agency’s jurisdiction. Participants examine the FDA’s systems-based inspection approach and key reference documents, including the Investigations Operations Manual (IOM). Sessions then cover inspection readiness: quality system and organisational preparation, SOPs, inspection response teams, documentation, facility preparation and employee training. The day continues with managing the inspection itself, including investigator do’s and don’ts, FDA employee interviews and real-time scenarios. It closes with exit interviews, responses to Form 483 observations and warning letters, remediation, and the legal implications of non-compliance.
Day 2: Post-Inspection Compliance and Practical Application
The second day focuses on returning to compliance while minimising downtime. It covers proactive risk management and crisis management, the remediation lifecycle, root cause analysis, corrective actions and GxP strategy. Participants learn how to request and prepare for FDA meetings, including PDUFA and pre-submission meetings, and how to manage enforcement actions, from Untitled Letters to warning letter close-out. The course concludes with enforcement trends, lessons from past inspections and mock inspections, including a project to host a mock FDA inspection and prepare a response to a 483 or warning letter.
Why You Should Watch
- Understand how FDA inspections are conducted and what investigators look for
- Prepare your facility, documentation and team using a structured readiness strategy
- Handle investigator questions and FDA employee interviews with confidence
- Respond to Form 483 observations and warning letters, and implement corrective and preventive action (CAPA)
- Practise through role-play and a mock FDA inspection
Course Provider
- Kelly Thomas
Quality, regulatory and compliance professionals who want to strengthen inspection readiness can purchase the recording through Research and Markets. Access details are sent by email.
For more information about this training visit https://www.researchandmarkets.com/r/rnvqtx
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