The Data Quality Journey – Focus on Environmental Monitoring Systems

Previously Aired on June 22nd, 2022

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Overview

This webinar will guide you into the journey of data, with a specific focus on Environmental Monitoring Systems for pharmaceutical cleanroom.

We will dig into the design, implementation and validation of an EMS as essential steps to ensure generation of meaningful data, then we will describe best practices to enable data to become “information”, and support improvement or correction decision.

What You'll Learn:

  • How to ensure your Environmental Monitoring System is properly designed and validated, with specific reference to the selection of sampling point and risk based approach
  • How to properly configure alert and action limits, and ensure a continuous adjustment/improvements of them, according ISO standards
  • How to make multidimensional analysis of data, to identify contamination root cause and generate CAPA
Who should attend:

All Pharmaceutical cleanroom users, especially those working in the following departments:

  • Quality Assurance
  • Quality Control
  • Information Technology
  • Engineering
  • Production

Presenters

Presenter
Daniele Pandolfi
(Presenter)
Product Line Manager Systems,
Particle Measuring Systems
View Biography
Presenter
Mike Auerbach
(Moderator)
Editor-in-Chief,
American Pharmaceutical Review