Seminar on Phase I GMPs

The Seminar on Phase I GMPs is dedicated to the differences between GMP requirements for early & later stage clinical.

The Seminar on Phase I GMPs covers topics such as:

  • Optimizing manufacturing processes
  • Issues with research greade material used for laboratory and non-clinical testing
  • Assessing scalability of manufacturing
  • Raw material requirements and process development
  • Study Essential elements of the CMC section of an IND
  • Planning the CMC for a potential IND
  • Various kinds of products: drugs, biologics, botanicals, diagnostics, medical device
  • Characterization of the active ingredient and finished product
  • Core principles of GMP regulatory requirements for all different products… durgs to medical devices
  • Manufacturing facility personnel eqquipment and requirements
  • Role of discussions with the FDA
  • Customizing regulatory compliance to a given product
  • Vendor management
  • Planning for the early stage with an eye toward large scale manufacturing
  • Manufacturing step development
  • Raw material handling issues for early stage products
  • Acceptable practices and tips
  • The scope of the FDA guidance
  • Specific requirements for drugs, biologic, and combination products
  • GMP requirements for exploratory clinical studies
  • Combination products with one or more new components
  • Specific issues for various kinds of combination products
  • GMP and QSR: which to follow for a combination product
  • CMC issues for 505(b)(2) products
  • Step by step introductions for process validation
  • Introduction to process validation for early stage manufacturers
  • Developing SOPs based on valiidation processes
  • Process validation reports and other documentation
  • Pilot scale manufacturing requirements GMP-grade and non-GMP grade manufacturing
  • Logistics of using contract manufacturing organizations for early stage products
  • Benefits and challenges with using local and international vendors

The Seminar on Phase I GMPs brings together:

  • Managers
  • Directors
  • Manufacturing
  • Supervisors in Regulatory Affairs

Past Events

   Seminar on Phase I GMPs 2019  16-17 Apr 2019, Philadelphia, PA, United States (83433)

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