Extreme closeup of a latex gloved hand holding a single pill.

Pharmaceuticals

Pre- and Post-Approval FDA Drug Inspections

About the Course

This Food and Drug Administration (FDA) compliance course explores the pre-approval and post-approval stages of drug inspections. The pre-inspection discussion will focus on process and documentation showing equivalence of bio-clinical batches to the proposed commercial product. The post-approval discussion will focus on general Good Manufacturing Practices (GMP) compliance. Other key discussion points include evaluation of manufacturing processes and finished products.