Electronic Data Auditing Techniques

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This training will help viewers to learn about a Brief introduction of the topic and scope of electronic data review in the pharmaceutical industry, FDA Citations, Regulatory Expectations, Approach to Part 11 requirements, What and How to Review Electronic Data Brief on Audit Trail Review - Contents of Audit Trail, Practical way for implementation, Training requirements, Probability of Errors and Mitigation Plan and finally References are shared.
During this training session, some practical examples are shared with are identified during different inspections/audits.