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SEP 08, 2016 8:00 AM PDT

Optimizing Quality Control Electronic Records for 21 CFR Part 11 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 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:  September 8, 2016
    TIME:  8:00am PST, 11:00am EST


    The FDA’s 21 CFR Part 11 guidance on the use of electronic records for data retention or submission is clear. With manually implemented Standard Operating Procedures for Quality Control testing and manual transcription of the test results still common practices in the pharmaceutical QC world, the resultant opportunities for human error raises concerns over the integrity of the data in the final electronic record, no matter how safely the record is stored.

    This Webinar describes how Quality Control instruments can be optimised for pharmaceutical use, helping to improve the integrity of the data in electronic records.


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