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.
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.
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