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Trends in FDA Compliance and Enforcement for Regulated Systems

March 3 @ 10:00 am - 11:00 am CST

$150

Overview:

Upon completion of this session, attendees will have an understanding of FDA compliance and enforcement as it relates to computer system validation.

They will understand how to develop the most robust computer system validation compliance program, focusing on the critical areas of interest to FDA. The attendees will have a good grasp of how to identify potential weaknesses and findings, as well as how to make recommendations for addressing and remediating them through risk mitigation.

In particular, we will focus on best practices for validating computer systems regulated by FDA and meeting compliance with electronic records and electronic signatures (21 CFR Part 11). We will also provide current FDA trends, including a focus on data integrity issues in industry, which will be illustrated through industry examples.

Organizer

compliance4All
Phone:
18004479407
Email:
compliance4all14@gmail.com
Website:
http://www.compliance4all.com

Venue

Online
Compliance Key,364 E Main Street, Suite 1009
Middletown, DE 19709 United States
+ Google Map
Phone:
7172088666
Website:
https://www.compliancekey.us/webinarDetails?industryId=4&webinarid=1562&speakerid=232&source=CC_LN