Good Preparation Practices for FDA and Notified Body Audits

Good Preparation Practices for FDA and Notified Body Audits

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.

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. 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.

Areas Covered in the Session :
FDA Inspection Overview
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
Quality Managers
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

Susanne Manz 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. She 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.

Refund Policy

membership
  Go PRIME   🛈 $ 240 SELECT
  Personal Plan 🛈 $ 3000 SELECT
  Business Plan 🛈 $ 9000 SELECT
  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance