21 CFR Part 11 Guidance for Electronic Records - 2018

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Category Electronic Records and Electronic Signatures, System Development Life Cycle, Clinical Data Managers and Scientists, Tobacco Industries, Life Sciences, regulatory compliance training

Deadline: June 10, 2018 | Date: June 12, 2018

Venue/Country: Online, U.S.A

Updated: 2018-04-18 15:35:28 (GMT+9)

Call For Papers - CFP

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: supportcompliance4All.com