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FEB 25, 2016 9:00 AM PST

WEBINAR: The revised ISO 14644-1 changes classification and monitoring methods: Are you prepared?

Speaker
  • Life Science Application Manager, Beckman Coulter, Particle Counting and Characterization
    Biography

      Currently the Life Science Application Manager at Beckman Coulter Life Sciences, PCC (Particle Counting and Characterization) (formerly part of Hach), Joe has been involved with the particle counting industry since 1984.  First joining Met One as an electronic design engineer, Joe has been involved in both airborne and liquid particle counter design, as well as multi-sensor systems for facility monitoring systems (FMS).  Joe has been involved in various standards involving particle counting in air and liquids.  He is part of the TC209 WG1 revision group on the main global cleanroom certification standard, ISO 14644-1 and -2, one of the two Americans on the committee. He is also involved with the ISO TC24/SC4 committees related to use and calibrations of various particle counting and characterization instruments.  In recent years, Joe has been giving information seminars in Asia, Europe and South America on particle counting and associated topics such as

      •    FDA enforcement
      •    Electronic Records and Signatures (21CFR Part 11)
      •    The change-over from FS 209E to ISO 14644-1 for room certification
      •    EU Annex I – controversies regarding airborne particle counting
      •    Changes to EP Injections regarding counting particles in final liquid injectables
      •    Determining Sampling positions in designing an FMS or fixed monitoring system
      •    Planning a strategy for Analytical Instrument Qualification (AIQ)

      Joe was originally a native of southern California, receiving a B.S.E.E. (Electrical Engineering) from UC Santa Barbara in 1976.  He has called southern Oregon home since 1981.


    Abstract

    February 25, 2016, 9:00am PT, 12:00pm ET, 5:00pm GMT

    This webinar, presented by one of the US members to the international revision group, discusses how the newly-revised ISO 14644-1 and -2 standard for counting airborne particles in cleanrooms may impact your classification and monitoring procedures. Classification is now discussed solely in the ISO 14644-1 section, detailing the methods to conduct the formal classification effort. In many cases, the revision requires an increase in the minimum number of locations needed for classification. The concept of the selection of positions as “representative” or “risk-based” are presented for the first time. The companion ISO 14644-2 section focuses on the design and characteristics of a monitoring strategy to support continued effective operation of a cleanroom or clean zone.

    This webinar will be helpful to all users of cleanrooms or clean zones (such as isolators, gloveboxes, BSC or filtered flow benches) and will provide useful information for plant managers, microbiologists, QA and QC managers as well as the persons actually executing the testing for airborne particles. All industries operating cleanrooms or clean zones will be impacted by this revision but additional commentary will be made on the relationship of these ISO documents and key biopharmaceutical documents such as the EU/PIC/s Annex 1. There will be a Q&A session at the end of the presentation.

    Learning Objectives:

    • Learn how the newly-revised ISO 14644-1 and -2 standard for counting airborne particles in cleanrooms may impact your classification and monitoring procedures
    • Learn useful information for plant managers, microbiologists, QA and QC managers as well as the persons actually executing the testing for airborne particles. 

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