Computer System Validation (CSV), Data Integrity and 21 CFR Part 11 Compliance

August 9 - 10, 2018 - GOA IN

Compliance Trainings

INFO@COMPLIANCETRAININGS.IN
Phone: +91-80-4170-0521

This new 2-day Seminar on Computer Systems Validation will explore proven techniques for reducing costs associated with implementing, using, & maintaining computer systems in regulated environments. The FDA performs GxP & Part 11 inspections, with an updated Annex 11 regulation, & companies must update their systems and processes to maintain compliance. Majority of inspection reports such as 483’s and Warning Letters quote issues with 21 CFR Part 11 and data integrity as deviations from GxP regulations. Only way to control and avoid warning letters is by receiving effective Training. Our presenter’s extensive years of experience in the field of third party audit can help your team to better understand & could help reduce your vulnerability of getting 483’s and warning letters, by great amount.

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