Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

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    Speaker: Carl Patterson

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    Duration: 60 Minutes
    Product Code: 50312
    Level: Intermediate


The webinar 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.


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.


  • 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


  • Provide background information on what microbiological aspects to audit for.
  • What international regulations should be referenced. 
  • ISO classification of rooms and how it should be applied
  • Product bioburden and why bioburden is important.
  • Validation and qualification of bioburden and manufacturing suites. 
  • Key sources of microorganisms and why this is important
  • What the source means in terms of root cause


All personnel who work for pharmaceutical manufacturing and contract manufacturing organizations where microbiological aspects are monitored and reported.


Carl Pattersonis a seasoned Pharmaceutical Manufacturing, Aseptic Processing, and Quality Assurance Professional who is based in San Diego, California. As soon as he discovered the importance of biotechnology in the area, he was inspired to enter the pharmaceutical manufacturing industry. However, his avid interest in all things biology, microbiology, and biochemistry officially began when he served in theU.S. Army as a Preventative Medicine Specialist and a Licensed Vocational Nurse.

Carl holds various degrees and certifications, includingan M.S. in Biomedical Quality Systems from San Diego State University, a Microbiology from the University of Texas, and Specialized Certificates in QA/QC & Biotechnology from UCSD.

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