Larry Spears
Instructor Larry Spears
Product Id 601449
Duration 60 Minutes
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Medical Device Registration & Listing, and Inspection Follow


Companies need to remain vigilant in understanding and applying current FDA law and regulation pertaining to the marketing of their devices in the US. Failure to do this raises their regulatory risk and hampers their ability to stay competitive in the rapidly advancing technological world of medical device manufacturing and marketing. The stakes are made even higher as device regulatory authorities around the globe are harmonizing their regulatory standards and requirements while increasing their collaborative efforts to ensure product safety.

This webinar will explore key concepts in helping your company stay ahead of the regulatory curve by understanding FDA operations and developing effective mitigations to reduce risk, wherever your devices are marketed around the globe.

Why should you Attend: Many companies struggle with understanding how FDA makes decisions on how to regulate medical devices that are being marketed. This includes not understanding how FDA uses registration and listing data for inspection planning to not knowing how they assess CAPA and complaint problems. In some cases, companies fail to manage inspections to reduce the risk of adverse findings, and they fail to address key issues in response to 483s and Warning Letters.

Here is your chance to better understand how FDA thinks and operates and what their key areas of focus and priority are from a former Compliance insider.

Areas Covered in the Session:

  • Registration and Listing regulatory requirements, process, and how FDA uses this data will be discussed.
  • CAPAs and complaints are key focus areas during Good Manufacturing Practice (GMP) inspections and this webinar will review the ins and outs of how to manage these systems and effectively address questions FDA will likely raise.
  • FDA strategic direction and how decisions are reached in developing inspection and compliance plans and how compliance actions are developed in response to violations encountered in inspections will be discussed.

Who Will Benefit:
  • VPs and Directors in Regulatory Affairs and Quality Assurance departments
  • Regulatory Affairs managers and professionals
  • Quality Managers and professionals
  • Small business owners

Speaker Profile
Larry Spears,/b> is a former CDRH Office of Compliance Director and Manager with over 20 years experience in administering regulations for the medical device industry and is currently an independent consultant to the medical device and pharmaceutical industries. His expertise in the exports area is derived from his years at CDRH where he made regulatory decisions that impacted the export program and the industry governed by it.

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