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LIVE Webinar: USP Quality Standards for Biologics
Course Information:
Course Description:
This webinar builds on the knowledge gained in the introductory course − USP Quality Standards for Medicines and focus on specific programs and activities of USP in the area of biologics.
Who Should Attend:
Scientists in QC/QA, regulatory affairs, analytical development, legal, and formulation/product development in biotech or biomanufacturing
Duration:
1 hour
Learning Objectives and Course Outline:
Learning Objectives
- Learn about USP Work Plan for biologics
- Learn about New USP standards for biologics
- Understand the importance of monographs and general chapters and what type of information and requirements are available for strength, quality, identity and purity of a biological product, API, or ancillary material
- Learn what information is enforceable by law and what information is meant for general guidance
- Learn USP initiatives to modernize certain biological monographs to include in-vitro cell based assays
- Learn about the standards USP intends to develop for therapeutic proteins, peptides, tissue products, cell and gene therapy products, ancillary materials, blood, and blood products
- Learn how you can become involved in the standard setting process in USP’s Biotech Standards Program
Contact Information:
Email PharmEd@usp.org or call +1-301-230-6304
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