How to Prepare Yourself for FDA`s on-going Part 11 Inspection Program 2019

Topics

• FDA`s current inspection and enforcement practices
• FDA and international regulations and guidelines
• Strategy for cost-effective implementation of Part 11: A six step plan
• FDA`s new Part 11 interpretation: learning from FDA inspection reports
• Justification and documentation for the FDA and your management
• Recommended changes to existing Part 11 programs to reduce costs
• How to prepare your company for Part 11 Inspections
• Going through case studies from laboratories, offices and manufacturing

Who should Attend

Attendees from:

• Manufacturing engineers
• Laboratory managers and supervisors
• Analysts and technicians
• IT managers and personnel
• All users of computer systems used in regulated environments
• Quality assurance managers and staff
• Consultants