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Why I should test raw materials for microbial presence: Microbiological and business risks

 
  August 06, 2013  
     
 
ComplianceOnline, Online Event
2013-08-16


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. That is why regulators from around the world have established bioburden limits, and call for absence of certain microorganisms, such E. coli, Pseudomonas spp., and Salmonella.

This webinar will address the regulatory and industry viewpoints on microbial presence in raw materials. You will learn how to implement a risk management program that assesses the hazard that raw materials poses to your products and manufacturing processes. Ultimately, the focus should be on patient safety and not just a regulatory requirement. The presenter will provide specific examples, from his experience, during the course to help you better understand and control microbial contamination in raw materials arriving at your facility.

Areas Covered in the Webinar:

  • What is a biopharmaceutical Raw Material?
  • Risks associated with raw materials
  • What are the contaminants?
  • Do you know where your raw materials come from?
  • Manufacturing Processes and control of microbial contamination
  • Establishing microbial limits for your raw materials
  • Consequences of microbial contamination
  • Mitigating the risk
 
 
Organized by: ComplianceOnline
Invited Speakers: Henry, is the founder of GMP TDC LLC, a New York-based training, development and consulting organization serving Life Sciences industries. He has 20+ years of Life Sciences experience having held positions of increased responsibility in Training, QC Microbiology and QA. 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: 2013-08-16
 
Registration: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703058?channel=hummolgen
E-mail: referral@complianceonline.com
 
   
 
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