|Thursday, October 20, 2016, 9:00AM - 3:30PM
Sheraton Clayton Plaza Hotel St. Louis
7730 Bonhomme Avenue, St. Louis, MO 63105
Assessment of Criticality of Quality Attributes for Biotherapeutics
The CASSS Midwest Discussion Group is committed to bringing job-relevant education and regulatory trends to CASSS members through meeting programs. The fall discussion group will focus on understanding criticality of quality attributes and their role in demonstrating bioprocess control and overall assurance quality. The discussion will include content from other regional, national or international forum organized by CASSS and speakers from industry and regulatory agencies. The program will also provide a platform for networking with both peers and regulatory authorities.
1. Discuss current FDA expectations for critical quality attributes selection criteria and assessment approaches
2. Learn industry practices and global implications of established CQAs
3. Understand phase appropriate CQA analysis
a. Evaluation of manufacturing experience
b. Statistical analyses
c. Determination critical vs non-critical
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