Prescription and OTC GMP Training

This Drug GMP webinar will review the pharmaceutical GMP regulations and discuss how to avoid deviation from them, what to do when deviations do occur and what happens when the regulations are not followed. It is crucial that all employees involved in pharmaceutical quality be familiar with these regulations and review them on a regular basis.

Why Should You Attend:

Current Good Manufacturing Practice (GMP) regulations are the FDA regulations that describe the requirements for the manufacturing of all pharmaceutical products, both prescription (Rx) and over-the counter (OTC).

The course will cover all the sections of the FDA pharmaceutical GMP regulations. Preparing for FDA by self auditing, and how to correct errors found, will be discussed. How frequently to expect FDA inspections, how to handle FDA inspections and how to avoid FDA Enforcement Actions will also be covered. Examples from recent FDA inspection observations (483s) and Warning Letters will be discussed.