Understanding Validation, GAMP 5, 21 CFR Part 11 and Data Integrity Training

This programme is ideal for professionals in the life sciences, including quality assurance, regulatory affairs, IT, and compliance, who seek to enhance their understanding of validation and regulatory frameworks.

Course Overview:

The Understanding Validation, GAMP® 5, 21 CFR Part 11, and Data Integrity Training Programme is a comprehensive three-day training designed to equip learners with essential knowledge and skills in validation, regulatory compliance, and data integrity management.

Participants have the flexibility to choose to attend individual courses or complete the entire programme over consecutive days.

Day 1: Understanding Validation Training
Delve into the foundational principles of validation, regulatory requirements, and the application of validation practices in real-world scenarios.

Day 2: GAMP® 5 Training - Fundamentals of GAMP® 5 Guidance
Explore GAMP® 5 guidance, the lifecycle approach to software validation, and the latest terminology relevant to quality assurance and regulatory compliance.

Day 3: Interpreting 21 CFR Part 11 and Data Integrity Training
Gain a thorough understanding of 21 CFR Part 11, including electronic records, electronic signatures, and the critical importance of data integrity in regulated environments.