OVERVIEW

International Seminar on Corrective And Preventive Action In FDA Regulated Industry is organized by Biopractice and would be held on May 12, 2017.

Program Key focus are :
• Review of Regulations • Definitions • Where/When is CAPA Required • Elements of a Corrective Action Program • Essential SOPs and Other Documentation • Detection of nonconformance • Identification of cause (Investigation) • Review of Investigation • Determination of Corrective/Preventive Action • Performance of Corrective Action • Implementation of Corrective Action • Effectiveness of Corrective Action • A Tool for Timeliness • Common Misconceptions • Root Cause Analysis • Fun and Games with CAPA: A Mini-Workshop • Sources of, and Application of, CAPA • How FDA Trains its Investigators to Review CAPA, and Recommended Compliance Methods

SPECIALITIES

Quality Management