FDA`s New Enforcement of 21 CFR Part 11 - 2018

Topics

• FDA`s new interpretation: learning from FDA inspection reports
• FDA`s current inspection and enforcement practices
• Justification and documentation for the FDA and your management
• Strategy for cost-effective implementation of Part 11: A six step plan
• Case studies how to avoid or respond to Part 11 related observations with corrective actions to fix current issues and preventive actions to prevent reoccurrence of the same or similar issues
• Going through case studies from laboratories, offices and manufacturing with graphical workflow of records, step-by-step description, recommendations for individual Part 11 requirements with justifications and documentation for the FDA and your management
• How to prepare your company for Part 11 Inspections

Who should Attend

• QA Managers and Personnel
• QC Managers
• Analysts
• IT Administrators
• Training Departments
• Regulatory Affairs
• Consultants
• Documentation Department