Joe McCall, SM (NRCM) – Technical Service Specialist, STERIS Life Sciences

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    • Joe McCall, SM (NRCM) – Technical Service Specialist, STERIS Life Sciences's presentations

    Joe is a Technical Service Specialist with STERIS Life Sciences.  He specializes in microbial control, environmental monitoring, excursion investigation and cleanroom issues.  Joe has over 20 years of experience in the biopharmaceutical and medical device industries, specializing in aseptic processing, cleanroom qualification, environmental monitoring, and risk management.  He is based in South Carolina USA and provides global technical support and expert consultation services for Critical Environments.  Joe is an invited conference speaker on pharmaceutical microbiology topics at Pharmaceutical Microbiology Forum (PMF), PDA, A3P Belgium, and is an invited lecturer at the University of Tennessee’s Aseptic Processing Training course.  He has developed material and is an instructor for upcoming PDA courses on Cleanroom Disinfection and Investigation of Microbial Contamination.  Joe holds a BS in Biology, is one of only a small handful of professionals certified as a Specialist Microbiologist in Pharmaceutical and Medical Device Microbiology by the American Society for Microbiology, and is an ASQ certified Six Sigma Green Belt.

     

    Topic: Cleanroom Contamination – Principles and Strategies for Investigation of Microbial Contamination Events.

    Synopsis: The presentation covers the key elements required for successful investigation of microbial contamination events.  The session presents investigation strategies for microbial contamination of environments, in-process samples, finished product sterility testing, and aseptic process simulations (i.e. sterile media fills).  Regulatory expectations for microbial investigations will be covered, as well as discussion of common pitfalls to avoid.

 

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