Microbiological Risk: Do I Really Need to Test Raw Materials for Microorganisms?

20 January 2015, Palo Alto, United States

Why Should You Attend:
Raw materials are often the major source of microbial contamination that is introduced into the manufacturing process. Raw materials of natural origin, such as animal and plant source, support an extensive and varied microflora. Some of these pose a risk to the product and patient.
This webinar will address the regulatory and industry viewpoints on the subject of testing raw materials for microorganisms. Each organization, as part of its risk management program, should assess the hazard that the raw materials pose to its products and manufacturing processes. Ultimately, the focus should be on patient safety and not just a regulatory requirement.
Attendees will learn how to assess the risk between reliance on your processes to remove microbial contaminants and the risk of potential recalls and/or patient welfare. You will learn how to effectively manage the risk of contamination from raw materials.

Areas Covered in the Webinar:
What is a raw material?
Regulatory perspective
Industry view
Consequences of contamination
Risk management

Henry Urbach

Henry Urbach, is the founder of GMP Training, Development and Consulting, GMP TDC LLC, a New York-based consulting organization serving the life sciences industries. He has over 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 both a scientific and business insight. He is a member of the ASTD, ASQ, and GMP TEA, a national organization of life sciences training professionals.


Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

Note: Use coupon code 232082 and get 10% off on registration.
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Online Event, Palo Alto, Palo Alto, 94303, United States

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