FDA Inspection Readiness
Instructor:
Susanne Manz
Product ID: 706450
- Duration: 90 Min
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 stress 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 especially benefit from this webinar.
Learning Objectives:
- FDA Inspection approach
- 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 and Directors
- Management Representative
- Quality Managers and Directors
- 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
President and Principal Consultant, Manz Consulting Inc
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, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. Susanne is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.
Refund Policy
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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
