Special Topic 6: Risk Management of Non-Ingredient Suppliers

Moderator(s)

• 

  Mai Huynh, MS

  Supervisory Chemist, CVM
  U.S. FDA
  Silver Spring, Maryland, United States

Panelist(s)

• 

  Tiffany Baker, MBA

  Consultant
  ValSource Inc.
  Providence, Rhode Island, United States

Regulatory Panelist(s)

• 

  Renée Blosser, MS

  Microbiologist, CVM
  U.S. FDA
  Rockville, Maryland, United States
• 

  Patricia Hughes, PhD

  Senior Scientific Advisor, CDER
  U.S. FDA
  Silver spring, Maryland, United States

Presentations:

• 08:30 – 08:45 EDT

  Risk Management of Non-Ingredient Suppliers: Current Regulatory Concerns
  

  Regulatory Presenter: Patricia F. Hughes, PhD – U.S. FDA
• 08:45 – 09:05 EDT

  The Use of QRM to Ensure Process and Product Control During Non-Ingredient Material Shortage
  

  Presenter: Tiffany A. Baker, MBA – ValSource Inc.
• 09:05 – 09:30 EDT

  Live Q&A (ST6)
  

  Moderator: Mai X. Huynh, MS – U.S. FDA

  Panelist: Tiffany A. Baker, MBA – ValSource Inc.

  Regulatory Panelist: Renée S. Blosser, MS – U.S. FDA

  Regulatory Panelist: Patricia F. Hughes, PhD – U.S. FDA