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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


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 or call +1-301-230-6304