While similarities dominate, some major differences still exist between EU and US regulations and regulatory expectations. Understanding this regulatory diversity and taking appropriate preemptive action is critical to achieving sustainable Quality Assurance and Control in each region.
This 90-minute interactive seminar will detail EU EMA Regulations and Annexes, plus US FDA Regulations and Guidance Documents, as a foundational starting point. You will then learn how to best prepare and execute your QA/QC compliance strategies and programs for operational and inspectional success.
Key differences you will learn include:
- Fundamental differences such as how GMP, QA, and QC are defined by regulators in both regions
- How innovator and biosimilar products are viewed, categorized, and handled in each region
- Differences in expectations during early-late clinical development
- Disparities in how post-marketing changes are viewed, regulated, and handled
- Divergence in inspectional emphasis