Track: SUPPLY CHAIN & MANUFACTURING CHALLENGES

B2: Supplier Oversight

Moderator(s)

• KQ

  Keduo Qian, PhD

  Chemist, CDER
  U.S. FDA
  Bethesda, Maryland, United States

Panelist(s)

• 

  Mirko Gabriele, PhD

  Senior Director, Global Sterile Strategy Technology and Innovation
  ThermoFisher Scientific
  Ferentino, Lazio, Italy
• 

  John McShane, MBA

  Vice President, BIologics
  Lachman Consultant Services, Inc.
  San Francisco, California, United States

Presenter(s)

• 

  Mirko Gabriele, PhD

  Senior Director, Global Sterile Strategy Technology and Innovation
  ThermoFisher Scientific
  Ferentino, Lazio, Italy

  Presentation Handout
• 

  John McShane, MBA

  Vice President, BIologics
  Lachman Consultant Services, Inc.
  San Francisco, California, United States

  Presentation Handout

Regulatory Panelist(s)

• 

  CDR Tara Gooen Bizjak, MBS

  Director, Manufacturing Quality Guidance and Policy Staff, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

Presentations:

• 13:30 – 13:48 EDT

  Greenfield Site Biologic Drug Substance Licensure Preparation
  

  Presenter: John M. McShane, MBA – Lachman Consultant Services, Inc.
• 13:48 – 14:23 EDT

  Risk Management in Technology Transfer: The Receiving Site Perspective
  

  Presenter: Mirko Gabriele, PhD – ThermoFisher Scientific
• 14:23 – 15:00 EDT

  Live Q&A (B2)
  

  Moderator: Keduo Qian, PhD – U.S. FDA

  Panelist: Mirko Gabriele, PhD – ThermoFisher Scientific

  Panelist: John M. McShane, MBA – Lachman Consultant Services, Inc.

  Regulatory Panelist: CDR Tara Gooen Bizjak, MBS – U.S. FDA