When: |
10 Oct through 10 Oct 2017 | |
CFP Deadline: |
10 |
|
Where: |
Online Event | United States | |
Website URL: |
http://www.compliance4all.com/control/w_product/~product_id=501506LIVE?channel=brownwalker_Oct_2017_SEO | |
Sponsoring organization: |
Netzealous LLC DBA - Compliance4All | |
Categories: |
Education / Legal / Other - Education |
Keywords:
Event description:
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 M...
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Posting date:
24 August 2017 | 193 views
Placement:
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