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Course Agenda
Day One (8:30 AM - 3:30PM) EST

8:30 – 10:30 AM: 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

10:30 – 10:45 AM: Break

10:45 – 12:00 noon: 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

12:00 – 12:45 PM: Lunch

 12:45 – 2:15 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

2:15 – 2:30PM: Break

2:30 – 3:30PM: 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 (8:30 AM - 3:30PM) EST

8:30 – 10:00 AM: 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 

10:15 – 10:15 AM: Break

10:15 – 12:00 noon: 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
 
12:00 – 12:45 PM: Lunch

12:45 – 2:15 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
 
2:15 – 2:30 PM: Break

2:30 – 3:30 PM: 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