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 Speaker Profile: Carolyn (McKillop) Troiano Carolyn Troiano has more than 35 years of experience in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe, developing and executing compliance strategies and programs. Contact Detail: Compliance4All DBA NetZealous, Phone: +1-800-447-9407 Email: [email protected]