

21 CFR Part 11 Guidance for Electronic Records - 2018
Presented By Netzealous LLC DBA - Compliance4All
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 |
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10:00am to 11:30am
General Admission: $150.00
All Ages
50 18004479407 UPCOMING EVENTS
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