March 8 - 12, 2015
Ernest N. Morial Convention Center
New Orleans, LA USA

Short Course of the Week.

Featured courses taught by industry experts.

What to Do During an FDA Inspection

Louise Harris
Nancy Karaszkiewicz

Alan Marnett
Course: Short Course #105

Length: 1 Day Course

Date: 03/12/2015 – Thursday

Fee: $500 ($710 after 2/20/15)

More Course Info

Target Audience

All Laboratory and Quality Assurance personnel involved in working for companies following Good Manufacturing Practice (GMP) and Good Laboratory Practices (GLP) need to be prepared for FDA inspections. This class will focus on employee preparation and conduct during inspections.

Course Description

The FDA is required to inspect manufacturers of FDA-regulated products, clinical study sites, and laboratories conducting studies that will be submitted for approval to the FDA. Scientists should be prepared to interact with FDA investigators. This course is designed to help you learn the Do’s and Don’ts of working with the FDA during an on-site FDA inspection. The experiences of the instructors will be shared, and participants will have the opportunity to be “inspected” in a mock FDA inspection.

Past Course Reviews

Great examples, very relevant topics
Good overview of impurities




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