About
This practical course provides a comprehensive understanding of Data Integrity principles in GMP-regulated environments. Participants will learn how to manage laboratory and manufacturing data throughout its lifecycle while meeting regulatory expectations and maintaining reliable, traceable, and compliant records. The course covers key concepts including ALCOA+, original data and metadata, audit trails, electronic records and signatures, user access control, data review, and computerized system requirements. Practical examples and real-world GMP scenarios will help participants identify common data integrity risks and apply appropriate controls in daily operations. Designed for professionals working in pharmaceutical, biotechnology, quality control, quality assurance, manufacturing, and laboratory environments, this course focuses on practical approaches that can be directly applied to GMP operations.
You can also join this program via the mobile app. Go to the app