Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar will help you create an inspection readiness plan so you are well prepared for an FDA inspection. This webinar can help you manage inspections efficiently and effectively. You’ll learn about the FDA’s inspectional approach, focus areas, and what documents they will be asking for. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.
Why Should You Attend:
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. But good preparation can ease the stress and lead to much more favorable results. This webinar can help you prepare a strategy and detailed plans to more successfully prepare for, manage, and respond to an FDA or Notified Body Inspection. If you’ve had a recall, an increase in MDRs, or it’s been more than 2 years since your last inspection, you can especially benefit from this webinar.Learning Objectives:
- FDA Inspection approach
- 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:
- Quality Engineers
- Compliance Specialists
- Compliance Managers and Directors
- Management Representative
- Quality Managers and Directors
- 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
Course Provider
Susanne Manz,
