Compliance with GMP and GDP regulations is essential for medicinal product development, manufacturing and distribution companies. Despite the recent Memorandum of Understanding between FDA and EMA, the two major regulatory bodies have different legal structures, functions and regulatory emphasis. Understanding of these similarities and differences ensures success during regulatory inspections.
This webinar will discuss how the different GMP/GDP systems came about, the legal status of each system, the difference between an FDA ‘investigator’ and an EMA ‘inspector’, the sanctions for non-compliance, how to design a fully compliant Quality Management System and future changes following the signing of the US/EU MOI.
- Legal basis of FDA and EMA
- Structures of FDA and EMA
- Understanding regulatory compliance
- US vs EU – Differences in laws, regulations, standards and guidelines
- 21CFR and Eudralex
- US/EU Memorandum of Understanding – what does it mean for compliance inspections?
- Content covered in all regulations
- Total quality system concept
- FDA ‘six-systems’ quality model
- Designing a Quality Management System to meet all regulatory standards
- Research and Development Departments
- Quality Assurance Departments
- Quality Control Departments
- Manufacturing Departments
- Regulatory Affairs Departments
- Engineering Departments
- Supply Chain / Outsourcing Departments
- Warehousing Teams
- API Manufacturers
- GMP/GDP Compliance
- Contract Manufacturing Organizations
- Contract Testing Laboratories