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.
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 plan 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:
FDA Inspection basics
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
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.