Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes leading to 483s and even warning letters. This webinar can help you be more professional and polished during an inspection. You will learn how to present information about your quality system in the most competent and professional manner.
An FDA inspection can be a very stressful and challenging experience. These stresses can lead even experienced people to make very costly mistakes during an inspection. Good preparation can ease the stresses and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plan to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection.
Areas Covered in the Session :
FDA Inspection Overview
Inspection preparedness strategy and planning
Key roles during an inspection
SME (Subject Matter Expert) training
Checklists for preparing
How to manage an inspection
Common mistakes to avoid
How to respond to inspection observations
Who Will Benefit:
Consultants and Contractors
Business Leaders wishing to present a professional and compliant organization
Cross-functional leaders wanting to make sure their organizations are well prepared
Anyone involved with an FDA or NB inspection