UNPA Seminar: Mock FDA GMP Inspection

Seminar Program


8:00 – 8:30 am

8:30 – 9:00 am
Overview of Mock Inspection Role-Playing Process
Introduction of Faculty

Loren Israelsen, Executive Director
United Natural Products Alliance (UNPA)

9:00 – 10:00 am
MODULE I: Review of Critical Dietary Supplement GMP Requirements
• Elements and inspection risk factors
• What kind of inspections are there?

10:00 – 10:45 am

MODULE II: The Inspection Begins
• FDA inspection SOPs — put them in writing
• Receptionist training
• Personnel training
• FDA 482 — Notice of Inspection. Do you sign this?

10:45 – 11:00 am

Noon – 1:00 pm
MODULE III: The Back Room / Front Room
• Who should conduct the inspection?
• What if everyone is out of town?
• Presenting documents and records to the inspector
• How to “control” the inspector
• Photographs, talking to staff, sample taking: What do you do?

Noon – 1:00 pm

1:00 – 2:00 pm
MODULE IV: Common Mistakes and How to Avoid Them
• Conducting your own “internal” mock inspection
• Dealing with aggressive or unfriendly inspectors

2:00 – 3:00 pm
MODULE V: The Audit
• Answering inspectors’ questions: Who, When and How?
• What is a refusal, and should you ever do it?
• Subject matter experts (SME) — when do you put an employee in front of an FDA inspector?
• When do you request a “time out”?

3:00 – 3:15 pm

3:15 – 4:45 pm
MODULE VI: The Inspection Closeout
• When and what should you promise FDA?
• Presenting corrective information
• What inspection paperwork should be signed and by whom?
• What do you do if you think you have been treated unfairly by the inspector?
• Post-inspection correspondence: Who writes it? You or your lawyer?
• FOI requests and 483 forms

4:45 – 5:00 pm
Wrap-up and Review of Critical Issues
Distribution of Sample Inspections SOPs

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