Best Practices for Managing an FDA Inspection
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and six sigma. She has worked at industry-leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices including roles as Executive Business Consultant, World Wide Director of Product Quality, and Director of Corporate Compliance. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Susanne is the author of Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, available on Elsevier and Amazon.
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 can help you prepare for and manage inspections efficiently and effectively. 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.
Learning Objectives
- FDA Inspection approach
- Inspection preparedness strategy and planning
- Inspection readiness checklists
- How to manage an inspection
- Key roles during an inspection
- SME (Subject Matter Expert) training
- Common mistakes to avoid
- How to respond to inspection observations
Who Should Attend
- Quality Engineers
- Compliance Specialists
- Compliance Managers and Directors
- CAPA specialists and managers
- Complaint Handling Unit specialists and managers
- Quality Managers and Directors
- Management Representatives
- 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
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 a good preparation can ease the stresses 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 benefit from this webinar.
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