In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting.
Why should you Attend:
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.
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
Limitations of scope of inspection
Response to investigation findings
Who Will Benefit:
Any personnel who may have direct interaction with FDA officials
Quality system auditors
Jeff Kasoff , RAC, CMQ/OE is the Principal Consultant at Lean to Quality, LLC. He s has more than 30 years of experience in Quality and Regulatory management. Over that time, He has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue.
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