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FDA Inspections - Do's and Don'ts 2019


Overview: 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:
Executive/senior management
Regulatory management
QA management
Any personnel who may have direct interaction with FDA officials
Consultants
Quality system auditors

Speaker Profile:
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.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: [email protected]

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