FEB 21, 2018 8:00 AM PST

WEBINAR: Automating Biopharma Quality Control to Reduce Costs and Improve Compliance

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: February 21, 2018
    TIME: 8:00AM PST, 11:00AM EST

    One report suggests that an average pharmaceutical manufacturing plant spends around €40M per year on quality control1. At the same time another report states that 79% of all 483 Warning Letters issued by the FDA in 2016 cited 21CFR part 11 data integrity issues2. Whilst re-training is a common response to an FDA 483 Warning Letter, this may be only part of the solution: was the problem simply that the worker(s) didn’t understand the SOP correctly, or was it really that the SOP is not robust enough to prevent future recurrences of the problem? Any process that automates the quality control SOP can potentially both reduce the impact of human error on data integrity issues and also bring welcome savings by reducing the time technicians need to devote to carrying out the SOP. This presentation takes a look at some common quality control procedures and how automation can help improve data integrity by reducing opportunities for human error, whilst at the same time potentially reducing operating costs.

    Learning Objectives:

    • Learn how automating quality control testing can reduce costs

    • Learn how 21CFR part 11 compliance can be improved by automating quality control testing

    • Learn how re-training is only part of a CAPA response to a regulatory inspection finding


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