Ensuring your Site is Ready for an FDA Inspection

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.
Instructor: Susanne Manz
Product ID: 501086
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
Why Should you Attend
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.

Areas Covered
  • 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 can Benefit
  • 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
$375
Recorded Session for one participant
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How it works
Live Session - How it works
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  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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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