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Compliance for Computer Systems Regulated by FDA - 2017

 
  August 09, 2017  
     
 
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
 
 
Organized by: Event Manager
Invited Speakers:
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.
 
Deadline for Abstracts: 2017-10-09
 
Registration:
Full Details & Registration Link:
 
E-mail: support@compliance4All.com
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