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

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 60 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

"Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems"

How to respond to 483s and warning letters

Description

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, 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.

Areas Covered

•      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

Industries who can attend

This 60-minute online course is intended for professionals in the Pharmaceutical, Clinical Data Management SaaS companies, and medical device companies . Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.


Speaker Profile

Edwin Waldbusser

Edwin Waldbusser retired from industry after 30 years in management of development of medical device products and development of company Quality Systems. Products included IVD devices, kidney dialysis systems and inhalation devices. 

His QS experience includes design control, risk analysis, CAPA, software validation, supplier qualification/control and manufacturing/non-conforming product programs.

Ed has a B.S. Mechanical Engineering from NYU and a M.B.A from Drexel University. He is certified by Lloyds of London as an ISO 9000 Lead Auditor and is a member of the Thomson Reuters Expert Witness network. He has 5 issued patents.

Back to Top