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Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing.


                                             Carl Patterson
Carl Patterson, M.S. is Keynote Speaker at Compliance key Inc. He has completed twelve (12) plus years in the biotechnology, pharmaceutical manufacturing, and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. 
 Webinar Id: LSHCACP003
 10:00 AM PT | 01:00 PM ET
 10/12/2017
  Duration 60 mins 
Overview
The seminar provides a comprehensive overview of auditing for microbiological aspects of pharmaceutical and biopharmaceutical manufacturing. The use of cleanrooms to manufacture drug products has been done for years. Microbiological aspects of manufacturing have been incorporated into the manufacturing process. By understanding the microbiological aspect, auditors can understand whether the manufacturing facility is under control. There are international and federal regulations that describe what aspects should be considered during manufacturing. This webinar will go into detail on those regulations and how they apply to pharmaceutical and biopharmaceutical manufacturing.
Why should you attend this webinar?
The microbial aspect of pharmaceutical / biopharmaceutical manufacturing is a key component of the overall manufacturing process. Understanding this component is vital in ensuring a pharmaceutical product meets the expectations of a regulatory agency. If this component of the manufacturing process is not well understood, consequences to be harmful to the patient and subsequently the company producing the product.  
Areas Covered in the Session:
  • International regulations (ISO)
  • Federal regulation (FDA, USP) 
  • Room classifications and how applied to manufacturing
  • Auditing company environmental programs for effectiveness
  • Reviewing of documents in relation to microbial aspects
  • Sources of common microorganisms
  • Identify root causes for many microbiological excursions
Who can Benefit:
All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported.
Compliance Key INC
717-208-8666
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Location: United States

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