This 90-minute webinar provides an overview of the key principles for assuring data integrity in GXP-regulated organizations and provides detailed examples of the foundational principles of Good Documentation Practices and how to apply these to both paper and electronic records. Examples will be presented for GMPs (laboratory and production), GCPs, GLPs, and Medical Devices. This webinar provides 15 minutes for Q&A.
Example topics include:
• What is “Data Integrity”?
• Regulatory Update & Focus
• Key Quality Management System Controls
• Data Life Cycle
• Paradigm Shift—paper to electronic
• 21 CFR Part 11 as “Good Documentation Practices for Electronic Data”
• US FDA & EU Observations