Understanding and Preparing for FDA's on-going Part 11 Inspection Program

Overview: 

FDA continues to enforce Part 11 through its ongoing Part 11 inspection and enforcement program.  Just in the last 24 months FDA issued more than 30 warning letters with citations Part 11 violations.  Citations are related to inadequate integrity, security and availability of electronic records but also related to validation of software and computer systems.

Areas Covered in the Session:

• FDA's current inspection and enforcement practices
• FDA's new interpretation: learning from FDA inspection reports
• Part 11 and the new EU Annex 11: similarity and differences
• Strategy for cost-effective implementation of Part 11: A six step plan
• Recommended changes to existing Part 11 programs to reduce costs
• Justification and documentation for the FDA and your management
• 6 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.
• 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.
• How to prepare for Part 11 Inspections

Who Will Benefit:

• IT managers and system administrators
• QA managers and personnel
• Analysts and lab managers
• Validation groups
• Software developers
• Validation professionals
• Training departments
• Documentation department
• Consultants