FDA GMP Inspection and For Cause Audit Training for Combination Products
This course will help you prepare your firm for FDA inspections and Notified Body (NB) audits. Using an interactive, hands-on approach, you will practice applying new knowledge and skills to the process end-to-end. You will use an FDA preparedness checklist to ready your site for inspection. During the course, you will establish and practice inspection management techniques and learn to communicate effectively with investigators. Learners will role-play investigation situations, such as preparing subject matter experts (SMEs) for answering investigator questions, front-room / back-room methodology, and opening and closing the inspection. You will gain the knowledge and practice to respond to observations or findings appropriately.