EU and US GMP/GDP – Similarities and Differences 2019

Topics

• Structures of FDA and EMA
• Legal basis of FDA and EMA
• US vs EU – Differences in laws, regulations, standards and guidelines
• Understanding regulatory compliance
• US/EU Memorandum of Understanding – what does it mean for compliance inspections?
• 21CFR and Eudralex
• Total quality system concept
• Content covered in all regulations
• Designing a Quality Management System to meet all regulatory standards
• FDA ‘six-systems’ quality model

Who should Attend

Attendees from:

• Quality Assurance Departments
• Research and Development Departments
• Manufacturing Departments
• Quality Control Departments
• Engineering Departments
• Regulatory Affairs Departments
• Warehousing Teams
• Supply Chain / Outsourcing Departments
• GMP/GDP Compliance
• API Manufacturers
• Contract Testing Laboratories
• Contract Manufacturing Organizations