Netzealous LLC DBA - Compliance4All, Online
2017-10-10
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.
Why should you Attend: This Webinar will help you understand in detail the application of FDA's 21
CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for
computer systems subject to FDA regulations.
Areas Covered in the Session: Validation Strategy System Risk Assessment GAMP 5 "V" Model 21 CFR Part 11 Electronic Records/Electronic Signatures (ER/ES) Security, Access, Change Control and Audit Trail
Who Will Benefit: Clinical Data Managers and Scientists Analytical Chemists Laboratory Managers Automation Analysts Manufacturing and Supply Chain Managers and Analysts Computer System Validation Specialists
Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: support@compliance4All.com
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