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Course Agenda

Day One (11:00 AM - 5:00PM) EST

11:00 – 12:00 PM: Lecture 1: Moving a Product out of R&D 

• 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

12:00 PM – 1:00 PM: Lecture 2: CMC Requirements for an 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

1:00 – 1.30 PM: Break

 1:30 – 3:30 PM: Lecture 3: GMPs for Phase 1 IND Products 

• 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
• Core principles of GMP

3:30 – 3.45 PM: Break

3:45 – 5:0 0PM: Lecture 4: Raw Material Management 

• Planning for the early stage with an eye towards large scale manufacturing
• Vendor management
• Raw material handling issues for early stage products
• Manufacturing step development

Day Two (11:00 AM - 5:00PM) EST

11:00 – 12:00 PM: Lecture 5: Process Validation in Early Stage GMP 

• Basic principles of process validation and process verification for Phase 1 GMP
• What needs to be validated and when
• Strategies for different processes
• Documentation and training expectations for Phase 1 products 

12:00 PM – 1:00 PM: Lecture 6: GMPs for Early Stage Medical Devices: QSR and GMP

• Devices for pilot testing
• Design control and documentation requirements.
• Up-scaling device manufacturing
• Specific issues with IDE and non-IDE clinical studies

 
1:00 – 1.30 PM: Break
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 1:30 – 3:30 PM: Lecture 7: Clinical Trials with Early Stage Products

• IRB issues with early stage and first-in-man clinical trials
• Informed consent requirements for early stage INDs
• Investigator’s brochure
• Investigational product management: supply, shipping and accountability

 
3:30 – 3.45 PM: Break
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3:45 – 5:0 0PM: Lecture 8: Outsourcing Early Stage Manufacturing 

• 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