FDA Inspections - Do's and Don'ts

In this webinar speaker will define the steps necessary to prepare for an FDA inspection and discuss details surrounding the management of inspections from announcement to close out meeting.

Jeff Kasoff
Instructor:
Jeff Kasoff
Date:
Friday, March 22, 2019
Time:
10:00 AM PDT | 01:00 PM EDT
Duration:
60 Minutes

More Trainings by this Expert   Product Id : 502277

Price Details
$150 Live
$290 Corporate Live
$190 Recorded
$390 Corporate Recorded
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Live + Recorded
$289 $340 Live + Recorded
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Overview:

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're in charge of compliance, usually in the background, and NOW you're 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 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. Also contained in 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.

Areas Covered in the Session:

  • 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 scope of inspection
  • Response to investigation findings
  • FDA guidance documents used by their inspectors

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 personnel who may have direct interaction with FDA officials
  • Consultants
  • Quality system auditors


Speaker Profile
Jeff Kasoff ,RAC,CMQ/OE is the Principal Consultant at Lean to Quality, LLC. He has more than 30 years of experience in Quality and Regulatory management. Over that time, He has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.

Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.




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