How to Prepare for and Host a FDA Inspection and Avoid 483s

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Tue, Mar 21, 2017
Length
60 minutes
Product Description

Be Prepared for an FDA Inspection and Avoid 483s


The FDA is required to conduct an inspection every two years and a company can reduce the likelihood of receiving 483s by being organized and prepared for the inspection. If a 483 is still received, knowing how to respond will lessen chances of receiving a Warning Letter.

In this webinar with expert speaker Edwin Waldbusser you will learn about the types of FDA inspections, and how to prepare for the FDA inspections through activities such as assigning dedicated personnel to specific tasks for the inspection.

You will also understand what the facility requirements are to support the inspection (front room, back room); the value of mock audits; how personnel should conduct themselves during the inspection; and the inspection process itself. Edwin will discuss how to respond to 483s and warning letters, if you receive them from the FDA.

Session Highlights

  • Personnel preparation
  • Facility needed to support inspection
  • Behavior during inspection—What not to sign!
  • Internal/ mock audits
  • 483 and warning letter response

Who should attend?

  • Engineering personnel
  • Manufacturing personnel
  • QA
  • Regulatory affairs
  • Management

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

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About Our Speaker

Edwin Waldbusser

Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the areas of design control, risk analysis and software validation for the past 8 years. Mr. Waldbusser has a BS in Mechanical Engineering and an MBA. He is a Lloyds of London certified ISO 9000 Lead Auditor and a member of the Thomson...   More Info
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