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21 CFR Part 11 Guidance for Electronic Records - 2018
Tuesday, June 12th at 10:00am PST
Online sale ends: 06/10/18 at 9:00am PST
Online
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.
Fremont, CA 94539
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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

Presented By

10:00am to 11:30am
Doors open at 12:00am

General Admission: $150.00

Age
All Ages

Online<br> 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA.<br> Fremont, 94539

18004479407

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