SEP 09, 2020 10:00 AM PDT

Classification and Routine Environmental Monitoring for GMP Cleanrooms

Speaker
  • Senior Marketing Manager, Beckman Coulter
    Biography
      Tony held the Convenorship of the ISO Working Group revising ISO 14698-1 & -2 for microbial control in cleanrooms and was the UK subject matter expert to the ISO Working Group who issued the 2015 revised versions of the ISO 14644-1 & -2 documents for cleanroom classification at the heart of the aseptic manufacturing chapters of both the European GMP and the USA cGMP documents. Tony was joint editor on the ISPE Guide to Ozone Sanitization of Pharmaceutical Water Systems and was also chief editor of the PHSS Best Practice Guide for Cleanroom Monitoring. Tony is employed by Beckman Coulter Life Sciences as a Senior Manager.

    Abstract

    DATE:  September 09, 2020

    TIME:   10:00am PDT, 1:00pm EDT

     

    The various GMP guidelines and International ISO standards around GMP cleanrooms are complex and often appear to give conflicting advice, leading to confusion and sometimes incorrect interpretation. In the case of Routine Environmental Monitoring, there is very little prescriptive advice and this lack of direct guidance leaves users struggling to know what to do and the temptation is to either create over-burdensome monitoring programs or to try to simply use the same monitoring plan as is used for classification. Both are incorrect. This webinar discusses the differences between GMP Cleanroom Classification and Routine Environmental Monitoring and explains how Beckman Coulter can help.

    The webinar will help cleanroom users understand the following:

    Learning Objectives:

    • The difference between cleanroom classification and routine monitoring.

    •  The differences between EU GMP and N America CGMP for aseptic manufacturing cleanroom contamination control.

    • How Beckman Coulter can help routine environmental monitoring managers address the confusion.

     

    Webinars will be available for unlimited on-demand viewing after live event.

     

    LabRoots is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E. ® Program. By attending this webinar, you can earn 1 Continuing


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