Data Integrity (DI) has become a critical focus for regulatory agencies in the pharmaceutical industry. Data serves as the foundational evidence for every activity performed, from drug development to production. When data integrity is compromised, trust in the processes and products diminishes, directly impacting regulatory compliance and public safety.
This course provides a comprehensive introduction to data integrity principles and best practices, essential for meeting current regulatory standards. Participants will gain an understanding of guidelines from major regulatory bodies, learn the significance of data quality and reliability, and explore practical steps to implement data integrity principles within their organizations.
Key Topics Include:
- Fundamentals of data integrity and its importance
- Regulatory expectations from agencies such as the FDA, EMA, and WHO
- Best practices to ensure accurate, complete, and reliable data
- Practical strategies for implementing DI principles within manufacturing and quality assurance processes
By the end of this course, attendees will be equipped with the knowledge and tools necessary to uphold the highest standards of data integrity, ensuring compliance and building trust in their pharmaceutical processes.
