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21 CFR Part 11 Guidance for Electronic Records - 2018

Du Mardi 12 Juin 2018 au Mardi 12 Juin 2018 à CA
A partir de: 10:00
Secteurs concernés: Acupuncture -Informatique médical -
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

PUBLIC, SECTEURS, ACCREDITATION
Accréditations : 0
Public concerné: Tous
Audience: Internationnale
Visiteurs/Participants: 50
Conférenciers: 1
Exposants: n.r
Type d'événement: Conférences en ligne
Secteur principal: INFORMATIQUE MEDICAL
Secteurs concernés: Acupuncture -Informatique médical -
ORGANISATEUR / ANNONCEUR

COMPLIANCE4ALL
161 Mission Falls Lane, Suite 216,
94539 Fremont
UNITED STATES

COMMENT
REFERENCE
Congrès, formations ou conférences médicales REF #28-8026
21 CFR Part 11 Guidance for Electronic Records - 2018
Publié sur congres-medical.com le : 2018-04-30 16:46:34
Congrès, formations ou conférences médicales en INFORMATIQUE MEDICAL
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