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The FDA Inspection Process: From SOP to 483 - Webinar

  • ID: 4613357
  • Webinar
  • 60 Minutes
  • Online Compliance Panel
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This FDA Inspection process training will discuss how to prepare for the inspection, what to do during the inspection and the close-out interview, and how to respond to the inspection.

Objectives of the Presentation

  • How to prepare for an FDA inspection
  • Development and contents of an SOP for FDA inspection
  • Personnel training before inspection
  • How to behave during an inspection
  • Limitations of the scope of an inspection
  • Response to investigation findings
  • FDA guidance documents used by their inspectors

Why Should you Attend

Does the FDA call in advance or just show up at my door? Where do I let the inspector go? Do I give them a tour? What should I let them see? Who should I let them talk to? Are they ever going to leave?
The FDA inspection is the most nerve-wracking event in the life of a regulatory professional - you are in charge of compliance, usually in the background and now you are in the spotlight and if your performance isn’t good, it’s not the show that may close, it’s your company! However, adequate planning, training, composure, and understanding should result in many encore presentations! This session will be the limits of FDA’s scope during an inspection, including what documents you are not required to show them, and the permissibility of photographs and affidavits

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  • Jeff Kasoff Jeff Kasoff,
    Director of Quality ,
    Medivators


    Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

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Who will Benefit

This webinar will provide valuable assistance to all companies that market in the U.S., since they are by definition subject to FDA regulation, in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

  • Executive/senior management
  • Regulatory management
  • QA management
  • Any person who may have direct interaction with FDA officials
  • Consultants
  • Quality system auditors
  • Quality Engineers
  • Compliance Specialists
  • Compliance Leaders
  • CAPA Specialists
  • Management Representatives
  • Compliance Managers and Directors
  • Quality Managers and Directors
  • Consultants and Contractors
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