FDA Inspection and Respond to 483 & How to Prepare them - 2017

MessageThis Webinar is over
Date Aug 8, 2017
Time 10:00 AM
Cost 150.00
Online
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.

Why should you 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 Will Benefit:
Engineering Personnel
Engineering Management
Quality Management
Corporate Management
Manufacturing Management
Division Management

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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

 


comments powered by Disqus
Create your own event
Turn your passion into a business.
Join our mailing list