Compliance for Computer Systems Regulated by FDA - 2017

What topics are covered by the course?

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: support@compliance4All.com

Who should attend?

Clinical Data Managers and Scientists
Analytical Chemists
Laboratory Managers
Automation Analysts

What will I be able to do on completion?

Netzealous LLC DBA - Compliance4All
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: support@compliance4All.com

How will I be assessed?

http://www.compliance4all.com/control/w_product/~product_id=501506LIVE?channel=coursesplus_Oct_2017_SEO

One Dial-in One Attendee

Price: US$150.00

Guide Price: $ 150


Lancaster
Wakefield
Outwood
Delivery: Online
Category: Health & Medical »
Duration: 90 Minutes
Qualification: N/A

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