Developing a Strategic Approach to FDA Compliance for Computer System

Website https://worldcomplianceseminars.com/upcoming_webinar | Edit Freely

Category GMP, GCP, GLP, Regulatory, QA/QC, IT, Audits.

Deadline: March 12, 2020 | Date: March 12, 2020

Venue/Country: U.S.A

Updated: 2020-01-06 15:33:25 (GMT+9)

Call For Papers - CFP

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, tobacco and other FDA-regulated industries.

Overview:

This webinar will provide guidance for planning, executing and validating a laboratory computer system, and managing the system in a validated state through the end of the system life cycle.

We will take you through the validation process, indicating key aspects of the approach, including GAMP 5 System Classification, Risk Assessment and overall development of a sound validation strategy.

The webinar will also address roles and responsibilities, timing of phases and deliverables, business process reengineering, organizational change management, change control and audit trails, training and documentation. You will learn what is required not only to validate your laboratory system, but maintain it in a validated state until it is retired or otherwise no longer in use.