FDA Inspections: What Regulators Expect and How to Prepare

This two-day course is a practical, hands-on program designed to provide pharmaceutical, biopharmaceutical, and biologics professionals with the information and tools they require to prepare for and manage an FDA inspection.  The course is ideal for Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. The course is designed to meet the objectives of preparing for – and surviving – an FDA inspection.  Participants will understand the guidelines, philosophy and practical approach of the FDA to inspections and visits, and develop a firm knowledge of the new FDA “systems approach” to inspections (QSIT), and the differences from the traditional “issues” approach.  Additionally, attendees will learn to develop strategies for preparing for and coping with FDA inspections and plan for self-audits.