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

  • Speaker:Edwin Waldbusser
  • Date: 17th December 2018 10:00 AM PST | 01:00 PM EST
  • Duration:90Min
  • Product Code:GRC-90504

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Recorded Session - How it works

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If you are unable to attend the meeting Live then you can opt in for the Live Recording instead. Access the recording of the webinar for 6 months. Contact our support for any questions. To prepare an invoice to pay by Check or Wire email us at support@grcts.com. 

Overview: 

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 

Handout:

  • FDA Inspection Readiness Checklist
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 Single: Attend the Live Meeting Online from any location

$169

2 Single Live Access: 2 people can attend the meeting Live from any location

$309

Recording: 6 Months Access to the Training which can be accessed from any location

$259

CD-DVD: Shipped within 2 working days

$359

USB - Shipped within 2 working days

$389

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

$289

Live + CD: Attend Live Meeting Online + Get the training CD shipped for free

$389

Live + USB - Attend Live online + Get the training USB shipped for free

$409

5 Member Group: 5 people can Attend the Live Online Meeting from any location globally

$559

10 Member Group: 10 people can Attend the Live Online Meeting from any location globally

$859

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