ComplianceOnline

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

Instructor: Henry Urbach
Product ID: 702964
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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
Instructor Profile:
Henry Urbach

Henry Urbach
Principal, GMP TDC LLC

Henry Urbach is a founder of GMP Training, Development and Consulting (GMP TDC) LLC, a New York-based consulting organization serving life sciences industries. He has over 20 years of life sciences experience having held positions of increased responsibility in training, QA, and QC microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of a post-regulatory action remediation, and developing an environmental monitoring training program. He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor (CQA). His technical education is further complemented by his BA degree in biology and MBA, which provide a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of life sciences training professionals.

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