Ensuring your Site is Ready for an FDA Inspection

  • Product Id : MD2626
  • Category : ,
  • Presenter :
  • Scheduled On : June 03 2019 1:00 pm
  • Duration : 90 Minutes

An FDA inspection can be a stressful and challenging experience. This webinar will help you understand the basics of FDA inspections so you can be well prepared. We will discuss how to prepare for an inspection, what to do during an inspection as well as common mistakes to be avoided.

The FDA continues to write 483 and Warning Letters to Medical Device Companies. Although an effective Quality System should always be “inspection ready”, many companies make simple mistakes leading to costly compliance issues. This webinar will help you prepare to competently respond during an inspection. You will learn how to best present information about your Quality System in a competent and factual manner. You will learn how to prepare your Subject Matter Experts (SMEs) to respond during an inspection. MD2626

Objectives of the Presentation :

  • Understand the basics of an FDA Inspection
  • Creating an inspection preparedness plan
  • Preparing your team and SMEs
  • Checklists for preparedness
  • How to manage an inspection at your facility
  • How to respond to an inspection
Areas Covered in the Session :

  • General Information about Inspections
  • Common mistakes
  • Planning for an inspection
  • Pre-inspection activities
  • When the inspection is announced
  • Checklists by area
  • During the inspection
  • After the inspection
  • Guidance for a 483 response
Who Should Attend:

  • Individuals new to Medical Device companies
  • Managers in functions outside of Quality wanting to prepare their organizations for an FDA inspection
  • Individuals that may be called in as subject matter experts during inspections
  • Compliance Personnel who will be the key contact during an FDA 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.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
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  • 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
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