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Which data and systems are subject to Part 11

Du Mardi 16 Janvier 2018 au Mardi 16 Janvier 2018 à CA
A partir de: 10:00
Secteurs concernés: Biotechnologie -Informatique médical -
DESCRIPTION
Overview: 
This webinar details the regulation and how it applies to computerized systems. Learn exactly what is needed to be compliant for all three primary areas: SOPs for the IT infrastructure, industry standards for software product features, and the 10-step risk-based validation approach.

Areas Covered in the Session:
Which data and systems are subject to Part 11
What Part 11 means to you, not just what it says in the regulation
Avoid 483 and Warning Letters
Explore the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
Ensure data integrity, security, and protect intellectual property

Who Will Benefit:
IT
QA
QC
Laboratory Staff
Managers
GMP, GCP, GLP Professionals

Speaker Profile:
Edwin Waldbusser is a consultant retired from industry after 20 years in management of development of medical devices (5 patents). He has been consulting in the US and internationally in the areas of design control, risk analysis and software validation for the past 8 years.

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

COMPLIANCE4ALL

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

COMMENT
REFERENCE
Congrès, formations ou conférences médicales REF #28-7700
Which data and systems are subject to Part 11
Publié sur congres-medical.com le : 2017-11-14 13:45:18
Congrès, formations ou conférences médicales en BIOTECHNOLOGIE
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