Seminar on Phase I GMPs 2019

The Seminar on Phase I GMPs 2019 is dedicated to the differences between GMP requirements for early & later stage clinical.

Topics

• 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

Who should Attend

• Managers
• Directors
• Manufacturing
• Supervisors in Regulatory Affairs