Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions. This session provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection.
09/12/2017 10:00 AM09/12/2017 04:00 PMTraining Topic: Do's and Don'ts During FDA InspectionsInstructor: Jeff Kasoff
Objectives of the Presentation
Understand the FDA inspection process and approach
What to do before, during and after the Inspection?
Responding correctly to the Investigator's questions
Tips for handling a FDA inspection the right way
Why the exit interview and close-out is an important part of handling an inspection
FDA policies regarding pre-announced inspections
Develop procedures for managing Inspections
Establish an inspection management team
Consider Inspection logistics in advance
Conduct the exit interview and close-out meeting with FDA very carefully
Possible Inspection outcomes
Why Should you Attend
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 isn't good, it's not the show that may close, it's 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.
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
Operations and Manufacturing
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