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Automating Biopharma Quality Control to Reduce Costs and Improve Compliance

Presented by:
Tony Harrison - Senior Marketing Manager, Beckman Coulter

Speaker 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.

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

Abstract:
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

Sponsored by:
Beckman Coulter

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