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

 
  February 04, 2013  
     
 
ComplianceOnline, Online Event
2013-03-05


This webinar will cover the regulatory perspective in testing raw materials for microorganisms and how you can manage the risk of raw materials being the major source of microbial contamination in your medical product manufacturing process.

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.

Areas Covered in the Seminar:

  • What is a raw material?
  • Regulatory perspective
  • Industry view
  • Consequences of contamination
  • Risk management
 
 
Organized by: Complianceonline
Invited Speakers: Henry, is a 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 Training, QA, and QC Microbiology. His experience includes managing GMP compliance and quality systems training, implementing a training program as part of 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 Training and Education Association (GMP TEA).
 
Deadline for Abstracts: 2013-03-04
 
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702635?channel=Hummolgen
E-mail: referral@complianceonline.com
 
   
 
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