How to prepare for and host a FDA inspection and respond to 483’s

  • Speaker:Edwin Waldbusser
  • Date: 29th January 2018 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90197

$169

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

Why You should Attend:

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.

Areas Covered in the Session

  • Personnel preparation
  • Facility needed to support inspection
  • Behavior during inspection-what not to sign
  • Internal/ mock audits
  • 483 response

Who can attend:

  • Engineering personnel
  • Engineering management
  • Quality Management
  • Corporate Management
  • Manufacturing Management
  • Division management
Instructor
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 9 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.

Available Options

Live Meeting Access: Attend the meeting Live via Webex

$169

Recording: Access it for 6 months from any location

$239

CD: Shipped within 2 working days

$339

Live + Recording: Attend Live + Access the recording for 6 months

$289

5 Member Group: Access the Live Meeting online from any location globally

$789

10 Member group: Access the Live Meeting online from any location globally

$1,429

Live + CD: Attend Live + Get a copy of the CD of the webinar

$389
For discounts and offers call support

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