Topics
- FDA`s new interpretation: learning from FDA inspection reports
- FDA`s current inspection and enforcement practices
- Recommended changes to existing Part 11 programs to reduce costs
- Strategy for cost-effective implementation of Part 11: A six step plan
- 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
- Justification and documentation for the FDA and your management
- How to prepare your company for Part 11 Inspections
- 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
Who should Attend
Senior attendees involved or interested in all personnel / companies in the API, Pharmaceutical, Medical device, Contract laboratories, CROs, Clinical testing and IT consulting fields., including:
- QA managers and personnel
- IT managers and system administrators
- Validation groups
- Analysts and lab managers
- Validation professionals
- Software developers
- Documentation department
- Training departments
- Consultants
