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
Course Director: ROBERT HASLAM
Robert Haslam, Managing Director, Somerset House Consultants has over forty years of experience in Quality Assurance, Production, Development, Clinical Trials and Regulatory Affairs gained in multinational and start-up companies. He is the Managing Director of a consultancy providing quality assurance, manufacturing, development and training support to pharmaceutical companies worldwide. He is an EU ‘Qualified Person’ for marketed and investigational products, including steriles and non-steriles, generics, biopharmaceuticals, herbals. He is also an ISO-qualified Lead Auditor; experienced in EU & FDA Good Manufacturing Practice.
He has extensive experience in GMP audits of drug substance, drug product and Investigational Medicinal Product manufacturers; outsourced activities; supply chain risk management. He has a successful track record of strategic management, facility qualification, designing and implementing quality systems, managing quality remediation programs, product development and outsourcing. He has designed and delivered bespoke GMP training courses to companies worldwide. Expert witness in litigation involving GMP compliance.