Catalog
Learning Objectives:
• Understand the role of stimuli article as opposed to Official or Informational Chapters in the United States Pharmacopeia (USP).
• Describe the process used by the USP Expert Panel to identify existing tests, gaps and challenges involved in drug performance testing.
• Evaluate the findings of the Working Group on continuous manufacturing as presented in the stimuli article.
• Question and provide input to the findings of the Continuous Manufacturing Working Group.
Recently Added Items
About this item
In 2019 USP created an Expert Panel (New Advancements in Product Performance Testing) to do a gap analysis on the need for and possible creation of tests/standards for measuring the performance of drug products. The results of Working Groups within the Expert Panel have been presented in a series of articles in Pharmacopeal Forum and Dissolution Technology. The purpose of this webinar is to present to stake holders and interested members of the pharmacy community, the findings of the Working Group on continuous manufacturing and allow for questions and suggestion from participants for improvement/modifications for the Working Group’s findings.
Learning Objectives:
• Understand the role of stimuli article as opposed to Official or Informational Chapters in the United States Pharmacopeia (USP).
• Describe the process used by the USP Expert Panel to identify existing tests, gaps and challenges involved in drug performance testing.
• Evaluate the findings of the Working Group on continuous manufacturing as presented in the stimuli article.
• Question and provide input to the findings of the Continuous Manufacturing Working Group.
Speaker Information
Hanlin Li, Ph.D.
Hanlin Li, Ph.D. is a Senior Director of Manufacturing Operations at Vertex Pharmaceuticals, located in Boston, MA. Prior to joining Vertex, Dr. Li had worked at Pfizer Global R&D and together has 20 years of pharmaceutical industry experience in analytical development and product life cycle management. Dr. Li has a Ph.D. degree in analytical chemistry from Iowa State University and has worked on numerous Marketing Applications with QbD filing and is a member of multiple IQ consortium groups, ISPE group and a USP expert panelist. Dr. Li has publications, book chapters and conference presentations in the subjects of continuous manufacturing, dissolution and predictive stability.