21 CFR Part 11 & Electronic Records Essentials

This practical course provides an essential understanding of FDA 21 CFR Part 11 and its requirements for electronic records and electronic signatures in regulated environments. Participants will learn how electronic systems can be used to create, manage, review, approve, and retain trustworthy and reliable records while supporting regulatory compliance. The course covers key topics including electronic records, electronic signatures, audit trails, user access control, system security, record retention, data traceability, and computerized system controls. Practical examples demonstrate how these requirements apply to laboratory data, quality documents, approval workflows, and other GxP-regulated activities. Designed for professionals in pharmaceutical, biotechnology, medical device, quality assurance, quality control, laboratory, and regulatory environments, this course provides practical knowledge for understanding Part 11 requirements and evaluating electronic systems used in regulated operations.