EU and US GMP/GDP Similarities and Differences 2019 is a webinar that covers topics such as:
- 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
EU and US GMP/GDP Similarities and Differences 2019 is intended for 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
