Objectionable Microorganisms in an Aseptic Environment

Why Should You Attend:

In recent years the number of recalls that are related to microbiological causes has been on the rise. By looking at the enforcement data from FDA, the majority of the recalls cite the presence of objectionable microorganisms as the prevalent cause.

The FDA unfortunately is not clear on defining what constitutes “objectionable microorganisms,” and often it’s left up to the organizations themselves to make that determination. This session will review FDA regulations and guidance on aseptic processing and provide definitions of “objectionable microorganisms.”

This webinar is designed to help organizations focus not so much on an almost impossible task of preventing the presence of objectionable microorganisms in their aseptic environment, but, on the task of preventing trends and setting up an applicable risk assessment strategy.

Areas Covered in the Webinar:

• Review of recall data
• FDA regulations
• FDA guidance on Aseptic Processing
• ICH guidelines
• Definitions of “objectionable microorganisms”
• Risk assessment of the presence of microorganisms in the aseptic environment and its impact on product

Henry Urbach 

Henry, is a founder of GMP Training, Development and Consulting (GMP TDC) LLC, a New York-based consulting organization serving Life Sciences industries