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Friday, December 07, 2018
9:00 AM - 12:00 PM
9:00 AM - 12:00 PM See all dates and Times
https://www.traininng.com/webinar/3-hour-virtual-seminar---best-practices-to-help-you-pass-an-fda-computer-system-validation-audit--200397live?upcomin
Overview FDA requires that all computer systems used to produce, manage and report on 'GxP' (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules.This webinar will help you understand the FDA's current thinking on computer systems that are validated and subject to inspection and audit.
It will also take into account areas where FDA will likely focus their effort, including on the higher-risk systems. As a 'GxP' system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed.
It will also take into account areas where FDA will likely focus their effort, including on the higher-risk systems. As a 'GxP' system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed.
