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21 CFR Part 11 Guidance for Electronic Records - 2018

Event Details

21 CFR Part 11 Guidance for Electronic Records - 2018

Time: June 12, 2018 from 10am to 11:30am
Location: Online
Street: 161 Mission Falls Lane, Suite 216,
City/Town: Fremont
Website or Map: http://www.compliance4all.com…
Phone: Event Manager
Event Type: webinar
Organized By: Netzealous LLC DBA - Compliance4All
Latest Activity: Apr 13, 2018

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Event Description

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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