Track: QUALITY ASSURANCE & QMS

A5: Aging Facilities vs. Modern Facilities

Moderator(s)

• 

  Patricia Hughes, PhD

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

Panelist(s)

• 

  Maik Jornitz, MSEng

  CEO
  G-CON Manufacturing, Inc.
  Manorville, New York, United States
• 

  Susan Schniepp

  Distinguished Fellow
  Regulatory Compliance Associates Inc.
  Las Vegas, Nevada, United States

Presenter(s)

• 

  Maik Jornitz, MSEng

  CEO
  G-CON Manufacturing, Inc.
  Manorville, New York, United States

  Presentation Handout
• 

  Susan Schniepp

  Distinguished Fellow
  Regulatory Compliance Associates Inc.
  Las Vegas, Nevada, United States

  Presentation Handout

Regulatory Panelist(s)

• 

  Rick Friedman, MS

  Deputy Director, OMQ, OC, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

Presentations:

• 13:45 – 14:05 EDT

  Case Study: Aging Facilities
  

  Presenter: Susan J. Schniepp – Regulatory Compliance Associates Inc.
• 14:05 – 14:30 EDT

  Impact of Aging Facilities on the Issue of Drug Shortage
  

  Presenter: Maik W. Jornitz, MSEng – G-CON Manufacturing, Inc.
• 14:30 – 15:15 EDT

  Live Q&A (A5)
  

  Moderator: Patricia F. Hughes, PhD – U.S. FDA

  Panelist: Maik W. Jornitz, MSEng – G-CON Manufacturing, Inc.

  Panelist: Susan J. Schniepp – Regulatory Compliance Associates Inc.

  Regulatory Panelist: Rick L. Friedman, MS – U.S. FDA