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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. 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.
Key Learning Objectives
- 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
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Susanne Manz
Quality and Compliance Expert / Auditor for Medical Devices
Susanne 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.
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