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
The Seminar on Phase I GMPs 2019 brings together:
- Managers
- Directors
- Manufacturing
- Supervisors in Regulatory Affairs