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Training Strategy & Consulting
How to Prepare for, Manage, and Follow-up to an FDA Inspection
Product Id: 600586
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Duration: 60 Minutes
Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Does the FDA call in advance or just show up at my door?
Where do I let the inspector go?
Do I give them a tour?
What should I let them see?
Who should I let them talk to? Are they ever going to leave?
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you're in charge of compliance, usually in the background, and NOW you're in the spotlight, and if your performance is not good, it is not the show that may close, it is YOUR COMPANY! However, adequate planning, training, composure, and understanding should result in many encore presentations!
This session will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection. Also contained in this session will be the limits of FDA's scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits.
Areas Covered in the Session:
How to prepare for an FDA inspection
Development and contents of an SOP for FDA inspection
Personnel training before inspection
How to behave during an inspection
What to show FDA during an inspection
Proper Post-inspection Follow-up
Limitations of scope of inspection
Response to investigation findings
FDA guidance documents used by their inspectors
Who Will Benefit:
Internal / External Auditors
Quality Assurance Professionals
Senior and mid-level Management
Quality System Auditors