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FDA's GMP Expectations for Phase I and First-in-Man Clinical Trials
Jul 27, 2017 - 09:00 AM - Jul 28, 06:00 PM
Link to Website
Hilton Garden Inn Philadelphia Center City 1100 Arch St, Philadelphia, PA 19107, USA,
Phone: 1 929 900 1853
Why should you attend:
Areas Covered in the Session:Seminar Day 1
Day 1 Schedule
Issues with research grade material used for laboratory and non-clinical testing
Optimizing manufacturing processes
Raw material requirements and process development
Assessing scalability of manufacturing
Planning the CMC for a potential IND
Study Essential elements of the CMC section of an IND
Characterization of the active ingredient and finished product
Various kinds of products: drugs, biologics, botanicals, diagnostics, medical devices
Manufacturing facility, personnel and equipment requirements
Core principles of GMP Regulatory requirements for different products: drugs to medical devices
Customizing regulatory compliance to a given product
Role of discussions with the FDA
Planning for the early stage with an eye towards large scale manufacturing
Raw material handling issues for early stage products
Manufacturing step development
Day 2 Schedule
The scope of the FDA guidance document
Acceptable practices and practical tips
GMP requirements for exploratory clinical studies
Specific requirements for drugs, biologics and combination products
Specific issues for various kinds of combination products
Combination products with one or more new components
CMC issues for 505(b)(2) products
GMP and QSR: which to follow for a combination products
Introduction to process validation for early stage manufacturers
Step by step instructions for process validation
Process validation reports and other documentation
Developing SOPs based on validation processes
Logistics of using contract manufacturing organizations for early stage products
Pilot scale manufacturing requirements GMP-grade and non-GMP grade manufacturing
Benefits and challenges with using local and international vendors
Peggy J. Berry
BUSINESS & MANAGEMENT CONFERENCES,
Keywords: fun, applications, Clinical , development , Fun , Health , healthy, implement, learn, Management
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