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 data integrity, 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, and topics 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.
| Member | Nonmember |
|---|---|
| US$145 | US$165 |
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For an enhanced learning experience, ISPE also offers these learning activities as live courses and gives you an opportunity to learn with a live instructor, ask questions, and participate in exercises. View upcoming courses
ISPE training is priced using Global Access Pricing, a model designed to reflect what a course actually costs in your country, not just what the US price converts to.
| Tier | Rate |
|---|---|
| Emerging Economy | $550 USD |
Global Access Pricing rates require an active ISPE membership.
