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Workshop

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

07 Jul 2020

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Join Risk-Based Approach to CSV, 21 CFR for a discussion of the webinar 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.


Timings

09:00 AM-06:00 PM (expected)
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Participants

upto 100
Delegates
Based on previous editions

Category & Type

Workshop
IT & Technology

Editions

07 Jul 2020


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Organizer

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WCS Consulting Inc.

USA 31 Total Events / 4 Upcoming Events

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