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

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

Contact Detail:

Compliance4All DBA NetZealous,

Phone: +1-800-447-9407

Email: compliance4all14@gmail.com

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.