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JUL 13, 2016 8:00 AM PDT

Particle counters must now be calibrated with ISO 21501-4: Do your instruments comply?

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

    July 13, 2016, 8:00am PT, 11:00am ET, 4:00pm GMT
     

    Changes in the classification standard, ISO 14644-1:2015, will have an impact on both the number of sample points needed to classify and on the quality and maintenance of the instruments needed to comply. The impact of the latest revision affects all cleanrooms users, even if you classify following Annex 1 from the EU GMP or PIC/s. It is also relevant to particle counters used in the EM program for routine monitoring or investigations.

    This webinar focuses on the key changes on the ISO 14644-1 standard with an emphasis on understanding the role of the calibration standard, ISO 21501-4, referenced in the latest revision.

    Make sure your methods and equipment for classification will comply!

    Learning Objectives:

    • Understand the key changes on the ISO 14644-1 standard with an emphasis on understanding the role of the calibration standard, ISO 21501-4, referenced in the latest revision.
    • Learn if your methods and equipment for classification will comply

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