Preparation for FDA and EU Regulatory Inspections 2018 is a workshop that covers topics such as:
- The requirements for an effective Quality Management System
- The legislation behind regulatory inspections and the different types of inspection
- How to prepare for a scheduled inspection
- What inspectors are looking for during an inspection
- Pitfalls and errors during an inspection
- What to look for in a pre-audit self-inspection
- How to respond to deficiencies during an inspection and the follow-up CAPA
- What to say, how to say it, what you should NOT say
Preparation for FDA and EU Regulatory Inspections 2018 brings together:
- Quality Control Departments
- Quality Assurance Departments
- Regulatory Affairs Departments
- Manufacturing Departments
- API Manufacturers
- Research and Development Departments
- Documentation Departments
- Production Departments
- Supply Chain / Outsourcing
- Warehousing
- Contract Testing Laboratories
- Contract Manufacturing Organizations
- Internal Auditors
