3-hr Virtual Seminar: US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus 2013

Topics

• Where Inconsistencies Become a Problem: WHO, ICH, Countries
• U.S., EU and Japan GMPs - Status of Harmonization and Where We`re Heading
• Category reviews
• ICH GMP organization
• GMP Comparisons for APIs
• Compliance with ICH Guidelines for GMPs
• GMP Comparisons for Excipients, Sterile products, Biologics and Clinical Packaging
• GMP Comparisons for Finished Products
• Outsourcing Management
• Differences on Area GMP Inspections
• Auditing Your Facilities for Global Considerations

Who should Attend

• Quality Assurance
• Manufacturing
• Project Managers
• Senior management
• Regulatory Compliance
• Qualified Persons (QPs)
• Packaging Experts
• CMC Personnel
• Consultants
• Auditors and Staff