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Compliance for Computer Systems Regulated by FDA - 2017

Du Mardi 10 Octobre 2017 au Mardi 10 Octobre 2017 à CA
A partir de: 10:00
Secteurs concernés: Biotechnologie -
DESCRIPTION
Overview:
The Webinar will focus on the importance of ensuring that electronic record/electronic signature (ER/ES) capability built into FDA-regulated computer systems meets compliance with 21 CFR Part 11. 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.

Areas Covered in the Session:
Validation Strategy
System Risk Assessment
GAMP 5 "V" Model
21 CFR Part 11
Electronic Records/Electronic Signatures (ER/ES)
Security, Access, Change Control and Audit Trail

Who Will Benefit:
Clinical Data Managers and Scientists
Analytical Chemists
Laboratory Managers
Automation Analysts
Manufacturing and Supply Chain Managers and Analysts
Computer System Validation Specialists

Speaker Profile:
Carolyn (McKillop) Troiano Carolyn 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.

Contact Detail:
Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
PUBLIC, SECTEURS, ACCREDITATION
Accréditations : 0
Public concerné: Tous
Audience: Régionale
Visiteurs/Participants: 100
Conférenciers: 1
Exposants: n.r
Type d'événement: Conférences en ligne
Secteur principal: BIOTECHNOLOGIE
Secteurs concernés: Biotechnologie -
ORGANISATEUR / ANNONCEUR

COMPLIANCE4ALL

161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congrès, formations ou conférences médicales REF #28-7580
Compliance for Computer Systems Regulated by FDA - 2017
Publié sur congres-medical.com le : 2017-10-12 11:45:34
Congrès, formations ou conférences médicales en BIOTECHNOLOGIE
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