21 CFR Part 11 Guidance for Electronic Records – 2018

Start Date : June 12, 2018
End Date : June 12, 2018
Time : 10:00 am to11:30 am

Phone : 800-447-9407
Email : support@compliance4All.com

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

Organized by

Organized by compliance4all14

Event Manager ,
161 Mission Falls Lane, Suite 216,

Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements. 

 

Compliance4All has a panel of acclaimed Experts whose professional trainings help regulatory professionals and organizations in a number of ways and take them to their goal of meeting regulatory requirements. Compliance4All offers path breaking professional training solutions to organizations that help them address pain areas and overcome the challenges and difficulties associated with meeting regulatory requirements.

Tel: 800-447-9407
Mobile: 8004479407
Email: support@compliance4All.com
Website: http://www.compliance4all.com/


Event Categories: Health & Nutrition.

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