Description

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

The Seminar on Phase I GMPs 2019 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