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, Italy

Apr
19

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

 
 Seminar/trade show (noCPF)

When:

  19 Apr 2022

Where:

  Online Event | United States

Website URL:

  https://www.complianceonline.com/risk-based-approach-csv-cfr-and-fda-compliance-webinar-training-706348-prdw?channel=Brownwalker

Sponsoring organization:

  Compliance Online

Categories:

  Medicine & Health - Pharmaceutical / Medicinal

Keywords:


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. Why Should You Attend: 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 valida... Read more

Posting date:

16 April 2022  |  304 views

Placement:

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