Track 10: Regulatory CMC and Product Quality
The Regulatory CMC and Product Quality Track provides a comprehensive view of risk-based approaches across the product lifecycle. The track scope spans from the scientific understanding gained through product and process development to lifecycle expectations for Global Regulatory CMC submissions, CGMP, and Quality Systems. Sessions address the increasing regulatory complexity of development and manufacturing for worldwide markets, accelerated development timelines, new technologies, emerging regulations, and increased scrutiny of manufacturing operations and data.
Sessions in Regulatory CMC and Product Quality
Monday, June 15
Tuesday, June 16
Thursday, June 18
- Demystifying Global Device Requirements: High-Level Comparison of Current Expectations
- N-Nitrosamines Contamination Case Lessons Learned
- Quality Considerations for Complex Drugs
Who is This Track Designed For?
Professionals involved in: regulatory affairs, manufacturing, quality assurance, quality control, drug development and/or manufacturing for small molecule drugs, biologics, and vaccines.