Compliance for Computer Systems Regulated by FDA - 2017

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]