Managing Documents, Records, and Data for FDA Inspections

Duration: 60 Minutes
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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. In this webinar, you will learn how to present documents, records, and data about your quality system in the most competent and professional manner.
FDA Inspection
Instructor: Susanne Manz
Product ID: 505867
Objectives of the Presentation
  • FDA Inspection basics
  • Inspection preparedness strategy and planning
  • Types of documents and data
  • Formats of documentation and data
  • Checklists for preparing
  • How to manage requests for documents during an inspection
  • Common mistakes to avoid
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. A strategy for managing documents, records, and data during an inspection is essential for success.

Areas Covered
  • Types of records, documents, and data that will be requested during an inspection
  • How to prepare, present, and manage information
  • Do’s and Don’ts of documentation
  • Documents the FDA is and is not allowed to see
  • Managing requests for live demonstrations of automated systems
  • How the FDA will analyze your data
Who will Benefit
  • Quality Engineers
  • Compliance Specialists
  • Compliance Leaders
  • CAPA Specialists
  • Management Representatives
  • Compliance Managers and Directors
  • Quality Managers and Directors
  • Consultants and Contractors
Topic Background
Every medical device manufacturer needs to be ready for an FDA inspection. It is not a question of if, but when you will be inspected. Good preparation and a plan for managing documents, records, and data are essential for success. The use of documents, records, and data is the proof necessary to show that you are complying with the medical device quality system regulations.

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Instructor Profile:
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 worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. 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 CQA (Certified Quality Auditor) 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.

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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