AUG 12, 2020 10:00 AM PDT

GMP Cleanroom Routine Environmental Monitoring & 21CFR part 11 Data Integrity

  • Senior Marketing Manager, Beckman Coulter
      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.


    DATE: August 12, 2020

    TIME:  10:00am PT


    Routine Environmental Monitoring in GMP cleanrooms is a manual process and is usually complex, involving thousands of sample data points per month, manual data transcription and all too frequently data gaps and data integrity challenges. This webinar discusses the difference between cleanroom classification and routine environmental monitoring, outlines the FDA 21CFR part 11 ALCOA guidance and shows how the new MET ONE 3400+ non-viable air particle counter from Beckman Coulter Life Sciences can automate routine environmental monitoring programs to help manage data integrity challenges.


    Learning Objectives:

    • Why ISO 14644-1:2015 cleanroom classification sample locations should not be used for routine environmental monitoring of GMP cleanrooms
    • How the FDA 2018 updated guidance on 21CFR part 11 data integrity applies to GMP cleanroom routine environmental monitoring
    • How automating routine environmental monitoring SOPs inside the air particle counter itself to form interactive sampling maps helps to automate the process and reduce human error


    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 Education credit once you have viewed the webinar in its entirety.

    Show Resources
    Show Resources
    • See more