A2: Non-Sterile Drug Products: Microbial Risks

Moderator(s)

• 

  Pahala Simamora, PhD

  Division Director, OPQ, CDER
  U.S. FDA
  SIlver Spring, Maryland, United States

Panelist(s)

• 

  Andrew Dick, MS

  Vice President Global Hygiene and Microbiology
  KDC/One
  East Windsor, New Jersey, United States

Regulatory Panelist(s)

• 

  Sandra Boyd

  Drug National Expert
  U.S. FDA
  Milwaukee, Wisconsin, United States
• 

  Erika Pfeiler, PhD

  Supervisory Microbiologist, CDER
  U.S. FDA
  Silver Spring, Maryland, United States

Presentations:

• 13:30 – 13:53 EDT

  The Complex: Science, Policy, and Case Studies of the Burkholderia Cepacia Complex in Aqueous Nonsterile Drugs
  

  Regulatory Presenter: Erika A. Pfeiler, PhD – U.S. FDA
• 13:53 – 14:30 EDT

  Microbiological Contamination Controls for Nonsterile Manufacturing
  

  Presenter: Andrew Dick, MS – KDC/One
• 14:30 – 15:00 EDT

  Live Q&A (A2)
  

  Moderator: Pahala Simamora, PhD – U.S. FDA

  Panelist: Andrew Dick, MS – KDC/One

  Regulatory Panelist: Sandra A. Boyd – U.S. FDA

  Regulatory Panelist: Erika A. Pfeiler, PhD – U.S. FDA