How to Prepare Yourself for FDA`s on-going Part 11 Inspection Program 2019 is a webinar that covers topics such as:
- 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
How to Prepare Yourself for FDA`s on-going Part 11 Inspection Program 2019 is intended for 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