Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Why Should You Attend:

The topic of “objectionable microorganisms” has been occupying minds of biopharmaceutical manufacturers for some time. Unfortunately, regulations are rather vague on the subject. The US drug regulations in 21 CFR211 state that drug producers must have procedures and appropriate testing to ensure that drug products are free of objectionable microorganisms, unfortunately, nothing in them helps us to understand what exactly is an “objectionable microorganism;” the interpretation is left to the organizations themselves to decide.

This lack of clear guidance from the regulators has not stopped the agency from placing a great burden upon the biopharmaceutical industry to ensure medicines are free from objectionable microorganisms. This is clearly evidenced by the recent recall data that show an increase in microbiologically-related causes. Objectionable microorganisms are especially prevalent in the recalls of non-sterile drug products. Drug manufacturers need to be concerned about the presence of objectionable microorganisms not only because of potential health hazards they may pose for patients but also due to the fact that their presence may lead to product spoilage and deterioration, which further places increased pressures on the bottom line. It is incumbent upon organizations to achieve two goals: ensure their products meet regulatory standards, and to ensure their stakeholders that they can be profitable. Mitigating the risk of presence of objectionable microorganisms in medicinal products ensures both.

Areas Covered in the Webinar:

• Review of recent recall data
• Definitions of Objectionable Microorganisms
• What is the risk if you find one?
• How bad the microorganism is depends on where you found it
• Examples of Objectionable Microorganisms
• Setting up an applicable risk assessment strategy

Who Will Benefit:

All Pharmaceutical and Biotechnology companies will benefit from this webinar. The titles are:

• Manufacturing
• Quality system auditors
• QA directors and managers
• Microbiology analysts and technicians
• Consultants
• Regulatory and Compliance Management

Henry Urbach
Principal, GMP TDC LLC

Henry Urbach, is the founder of GMP Training, Development and Consulting, GMP TDC LLC, a New York-based consulting organization serving Life Sciences industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in GMP Training and QC Microbiology. His experience includes managing and implementing CGMP compliance and quality systems training, for major pharmaceutical and biotechnology organizations. He is a dynamic speaker specializing in FDA and ICH compliance. He is a Certified Quality Auditor. 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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