Best Practices for Preparing for an FDA Inspection

Speaker

Instructor: Susanne Manz
Product ID: 706774

Location
  • Duration: 90 Min
Are you ready for the FDA to 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.
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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 a 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 Inspection. If you’ve had a recall, an increase in MDRs, or it’s been more than two years since your last inspection, you can benefit from this webinar.

Areas Covered in the Webinar:

  • FDA Inspectional approach
  • Inspection strategy and planning
  • Preparing
  • 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

Who Will Benefit:

  • Quality Engineers
  • Compliance Specialists
  • CAPA 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
Instructor Profile:
Susanne Manz

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.

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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.If you have any concern about the content of the webinar and not satisfied 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).

 

 

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