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GAMP Microlearning: Data Integrity and 21 CFR Part 11

GAMP® Microlearning: Data Integrity and 21 CFR Part 11

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on DI and Part 11. The "Data Integrity and 21 CFR Part 11" section of the GAMP® Basic Principles (T45) training course provides a comprehensive overview of regulatory expectations for electronic records and electronic signatures in GxP environments. Drawing from FDA guidance, MHRA definitions, and the ISPE GAMP® Records and Data Integrity Guide, the module emphasizes the importance of complete, consistent, and accurate data throughout its lifecycle. Participants explore the scope and application of Part 11, including predicate rules, audit trails, access controls, authority checks, and signature manifestations. The course highlights common inspection findings, risk-based compliance strategies, and the role of organizational culture and leadership in fostering data integrity. Learners gain the knowledge to assess systems for Part 11 applicability, define audit trail requirements, and implement compliant electronic signature controls.
165.00