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21 CFR Part 11 Compliance for Computer Systems Regulated by FDA

August 12 @ 8:00 am - 2:00 pm CDT

$445

Overview

 

The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11.  This includes development of a company philosophy and approach, and incorporating it into the overall computer system validation program and plans for individual systems that have this capability.

FDA’s 21 CFR Part 11 was enacted in the late 1990s and implementation success across the pharmaceutical and other regulated industries has been mixed.  There are very specific limitations that arise when using ER/ES capability, such as the elimination of print capability to prevent users from making decisions based on a paper record as opposed to the electronic record.  It also requires very specific identification of users that ensures the person signing the record is the same person whose credentials are being entered and verified by the system.

Organizer

Planurevents
Phone:
+1-800-447-9407
Email:
planurevents2020@gmail.com
Website:
https://www.planurevents.com/

Venue

Online Event
Compliance Key,364 E Main Street, Suite 1009
Middletown,DE,USA, DE 19709 United States
+ Google Map
Phone:
+1 7172088666
Website:
https://www.compliancekey.us/webinar/1707/filing-irs-form-1099-nec-w-9-update/source_ccln