How to Manage an effective FDA Inspection

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:

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

Who Will Benefit:

Quality Engineers
Compliance Specialists
Compliance Managers
Quality Managers

Speaker and Presenter Information

Susanne Manz

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.