21 CFR Part 11 Guidance for Electronic Records - 2018

MessageThis Webinar is over
Date Jun 12, 2018
Time 10:00 AM to 11:30 AM
Cost $ 150.00
Online
Overview:
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. This is critical in order to develop the appropriate 

validation strategy and achieve the thoroughness required to prove 

that a system does what it purports to do.

Areas Covered in the Session:
System Risk Assessment
GAMP 5 "V"Model
21 CFR Part 11
Electronic Records/Electronic Signatures (ER/ES)
Security, Access, Change Control and Audit Trail
Policies and Procedures

Who Will Benefit:
Information Technology (IT) Analysts
IT Developers
IT Support Staff
QC/QA Managers and Analysts

Speaker Profile:
Carolyn (McKillop) 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.

Event Fee: One Dial-in One Attendee Price: US$150.00

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com

 


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