Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance

Event Details

Time: January 12, 2022 from 10am to 1pm
Location: online
Street: Compliance Online
City/Town: Palo Alto
Website or Map: https://www.complianceonline.…
Phone: 8887172436
Event Type: webinar
Organized By: Complianceonline
Latest Activity: Jan 1, 2022

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Event Description

FDA’s recent focus on data integrity during computer system validation inspections and audits has brought this issue to the forefront of importance for compliance of systems used in regulated industries. These include all systems that “touch” product, meaning they are used to create, collect, analyze, manage, transfer and report data regulated by FDA. All structured data, including databases, and unstructured data, including documents, spreadsheets, presentations, images, audio and video files, amongst others, must be managed and maintained with integrity throughout their entire life cycle. It is a risk-based approach that leads to the best results and compliance with FDA’s expectations.