How to Prepare for and Host an FDA Inspection and respond to 483's

Edwin Waldbusser Instructor:
Edwin Waldbusser 
Tuesday, June 21, 2022
10:00 AM PDT | 01:00 PM EDT
60 Minutes
Webinar ID: 500530

More Trainings by this Expert

Price Details
Live Webinar
$149 One Attendee
$299 Corporate Live
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded
Combo Offers
Live + Recorded
$299 $348 Live + Recorded
Corporate (Live + Recorded)
$599 $698 Corporate
(Live + Recorded)

Live: One Dial-in One Attendee

Corporate Live: Any number of participants

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Overview:

In this webinar you will learn how to prepare for an inspection and how to respond to a 483 or Warning letter if you receive one.

You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, and how personnel should conduct themselves during the inspection, the inspection process and how to respond to 483s and warning letters.

How to respond and when is critically important. Also covered will be the FDA’s rights during the inspection and documentation you are not required to show them.

Why you should Attend:
FDA will inspect you! Are you ready? FDA is required to conduct an inspection every two years.

A company that is prepared for the inspection is less likely to receive 483’s than a disorganized company. If a 483 is received knowing how to respond will lessen chances of receiving a Warning Letter.

Handout is inspection readiness checklist

Areas Covered in the Session:

  • Personnel Preparation
  • Procedure to follow during audit-what to do/ what not to do
  • Facility Requirements to support Inspection
  • Behavior during inspection-what not to sign
  • Internal/ Mock Audits
  • 483/ Warning Letter response

Who Will Benefit:
  • Engineering Personnel
  • Engineering Management
  • Quality/ Regulatory Management
  • Corporate Management
  • Manufacturing Management
  • Division Management
  • Legal Counsel


Speaker Profile
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 US and internationally 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 Reuters Expert Witness network.


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