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]

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