NOV 05, 2019 8:00 AM PST

Validating a Pharmaceutical Total Organic Carbon Benchtop Analyser to ICH Q2

Speakers
  • 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 holds a Bachelor's Degree in Electrical & Electronic Engineering and is employed by Beckman Coulter Life Sciences as a Senior Marketing Manager.

      Experienced in water system TOC, conductivity and ozone analysis and cleanroom environmental monitoring as well as particle characterisation, Tony has spent the last fifteen years in applied metrology for the pharmaceutical and healthcare manufacturing industries. Prior to that, he worked for companies providing process control automation solutions for manufacturing industries.

      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 a well-known international speaker and has provided educational seminars on TOC, liquid particle counting, ozone sanitization for water systems and cleanroom monitoring in UK, France, Italy, India, Malaysia, China, USA, Scandinavia, Ireland, Hungary, Switzerland, Indonesia, Belgium, Greece, Switzerland, Turkey, Egypt, Denmark, Poland, Italy and most recently South Africa and Columbia.

    Abstract:
    DATE: November 5, 2019
    TIME: 8:00am PST
     
    The International Committee for Harmonisation issued their recommendations on validating an analytical instrument, ICH Q2, to support users of analytical equipment such as Total Organic Carbon (TOC) analysers. It covers all the important aspects of validating an analyser, including ensuring that it is suitable for the test conditions of the application and the random effects on intermediate precision caused when different technicians perform the same test, i.e. human error. This webinar explains the different aspects of ICH Q2 and how they apply to TOC analysers used in pharmaceutical applications.
     
    Learning Objectives:
    • Summarize how to interpret ICH Q2 for TOC analysers
    • Identify how to demonstrate compliance to ICH Q2 for TOC analysers
    • Explain the opportunities to improve TOC analysis data integrity in your QC laboratory
     
    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.

     


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