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.
Areas Covered in the Session :
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
Who Should Attend:
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