Preparation for FDA and EU Regulatory Inspections 2018

Topics

• 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

Who should Attend

• 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