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You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

  • Training

  • 60 Minutes
  • Compliance Online
  • ID: 5974414
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

Why Should You Attend:

Due to increased scrutiny by the FDA and other regulatory agencies, companies must now determine how to reduce the risk if they find objectionable microorganisms. This webinar will provide an expert's insight into reducing this risk.

GMPs require that products be free of objectionable microorganisms and it is incumbent upon manufacturers to ensure their products meet these requirements. But just what is an objectionable microorganism? This webinar will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.

Areas Covered in the Webinar:

What is an objectionable microbe?
  • Pathogens vs. objectionables
  • Just how objectionable is it?
  • Consider the risk
  • Performing a risk assessment
  • Examples

Who Will Benefit:

All FDA regulated companies will benefit from this webinar - pharmaceutical, biotech, medical device companies and laboratories.
  • Quality system auditors
  • QA directors and managers
  • Information technology managers and personnel
  • Microbiology analysts and technicians
  • Consultants
  • Regulatory and Compliance Management
  • Microbiologists

Course Provider

  • Henry Urbach
  • Henry Urbach,