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SEP 05, 2017 8:00 AM PDT

WEBINAR: 21 CFR Part 11 Data integrity for On-Line TOC instrumentation

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 5, 2017

    TIME: 8:00AM PT, 11:00AM ET

    A recent report indicates that circa 79% of 483 warning letters issued by the FDA to the biopharmaceutical industry in 2016 cited deficiencies in data integrity. The FDA outlines their expectations for quality critical instrumentation in the GMP environment in their 21 CFR Part 11 ruling. This webinar takes a look at how quality-critical on-line Total Organic Carbon (TOC) and conductivity instrumentation can be configured to help companies comply with the FDA’s expectations on data integrity, including the use of Microsoft Active Directory and PDF data export.


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