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
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.
• 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.