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Discussion Group

EVENTS

Watch this space for upcoming meeting announcements! We will continue sponsoring live and hybrid meetings in 2024

May 23, 2024, 3-5 pm, MEETING at Waters IMMERSE LAB in Cambridge

  • CHECK BACK IN A COUPLE OF DAYS FOR REGISTRATION DETAILS!
  • SPEAKER: Ernie Hillier, EJH Consulting
  • TITLE: Technological advances providing higher quality information for PAT process understanding leading to greater knowledge and management for continuous manufacturing.
  • ABSTRACT:
  • As we look back at 2004 and the FDA’s Guidance for Industry PAT – Framework for Innovative Pharmaceutical Development and Quality Assurance will start with a brief introduction. We'll start with quality by design parentheses (QbD) as the backbone/structure to process analytical technology (PAT) and how things have progressed over the last 20 years. We're going to break it down into four elements: sampling, chemistry, sensors, and software programs that are an integral part of the elements mentioned in addition to specialized software that has been developed to optimize the data specifically coming from the many types of sensors that are utilized at specific times in the workflow. In following the evolution of the existing core technologies as well as enhancements to those technologies as well as new technological solutions. Finally tying the QbD, PAT, and continuous manufacturing story with case studies in showing what is possible as well as the impact.

PAST EVENTS

  • "Metabolomics and lipidomics in Drug Discovery and Precision Medicine" by Dr. Dr. Jurre Kamphorst, October 12, 2023
  • "LC UV MS methods for the analysis of therapeutic oligonucleotides and mRNA" by Dr. Martin Gilar, May 25, 2023

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