- TypeWebinar
- Location Aurora, Colorado, United States
- Date 24-10-2018
Engineering
Education/Teaching/Training/Development
Business Development
Medical/Healthcare/Hospital
OTHERS
OVERVIEW
In this webinar you will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the FDA 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 techniques for responding 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.
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 an FDA warning letter.
AREAS COVERED
LEARNING OBJECTIVES
Learn how to handle an FDA inspection efficiently. Also learn effective strategies to avoid 483s as well as for responding to an FDA warning letter.
WHO WILL BENEFIT
For more detail please click on this below link:
Email: [email protected]
Toll Free: +1-888-300-8494
Tel: +1-720-996-1616
Fax: +1-888-909-1882
Learn the strategies to prepare for and host an FDA inspection and also understand the value of mock audits. The webinar also discusses how to avoid 483s and respond to an FDA Warning Letter.
Training Doyens 26468 E Walker Dr Aurora, Colorado 80016
+1-720-996-1616