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. In addition, for those interested, this webinar offers an additional 30 minutes for Q&A upon completion of the webinar, from 12:30pm-1:00pm ET.
Example topics include:
• What is “Data Integrity”?
• Regulatory Update & Focus
• Key Quality Management System Controls
• High Level Overview of Data Life Cycle & Data Governance & Management Governance
• Paradigm Shift—paper to electronic
• 21 CFR Part 11 as “Good Documentation Practices for Electronic Data”
• US FDA & EU Observations