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Developing a Strategic Approach to FDA Compliance for Computer System Validation - Webinar


2017, November 30

Clinical » Webinar


OVERVIEW
This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating 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
• Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Validation Strategy that will take into account the system risk assessment process

LEARNING OBJECTIVES
• Learn about industry best practices related to compliance and computer system validation
• Learn about strategies for reducing the cost and complexity of compliance with FDA regulations
• Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process

WHO WILL BENEFIT
• Clinical Data Scientists
• QC/QA Managers
• Compliance Managers
• Laboratory Managers

SPEAKER
Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health and other FDA-regulated industries. She is currently managing a large, complex data migration, analytics and reporting program at a major financial institution.

For more details click on this link:
www.trainingdoyens.com


Venue

Internet - webinar

Organizer

Phone: +1-720-996-1616
Visit organizer website



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