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.

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.

What You Will Learn:

Day 1: Understanding Validation

• Introduction to Validation:
  Historical context, definitions, and regulatory expectations surrounding validation practices.

• Validation Process:
  Key stages of validation using the 'V' model approach, regulatory requirements, and implications of non-compliance through case studies.

• Real-World Applications:
  Engage with practical scenarios to determine suitable actions for workplace improvements and compliance.

Day 2: GAMP® 5 Fundamentals

• GAMP® Guidance Development:
  Insights into the development of GAMP® guidance and its relevance in regulatory compliance.

• Lifecycle and Phases:
  Understand the software lifecycle, including phases from concept to retirement, and the role of quality risk management.

• Operational Management:
  Explore security, change management, CAPA processes, and the relationship between GAMP® activities and qualification terminology.

Day 3: 21 CFR Part 11 and Data Integrity

• Understanding 21 CFR Part 11:
  Overview of the regulation, its requirements, and the differences between guidance and regulation.

• Key Terminology:
  Identification of essential terms and definitions related to document lifecycles, validation, and risk management.

• Data Integrity Focus:
  Delve into challenges, control measures, and the current regulatory landscape regarding data integrity as highlighted by FDA and EU GMP guidelines.