Knock, Knock, Who's There? Preparing for an FDA Inspection
This webinar can help you manage inspections efficiently and effectively, 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.
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Are you ready for that knock on your door? 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 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.
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 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.
Areas Covered in the Session:
Who Will Benefit:
- FDA Inspectional approach
- Inspection strategy and planning
- How to manage an inspection
- Key roles during an inspection
- Training for SMEs (Subject Matter Experts) and other roles
- Do's and Don'ts
- Common mistakes to avoid
- How to respond to inspection observations
- Quality Engineers
- Compliance Specialists
- Compliance Managers and Directors
- Quality Managers and Directors
- 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
Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.
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 Certified Quality Auditor (CQA) certification 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.