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ISO/IEC 17025:2017: New definitions for specifications, decision rules, & risk assessments for calibrations

ISO/IEC 17025 Webinar
Industrial Measurements
Life Science

The 2017 revision to ISO/IEC17025 includes better guidance on conformity and a new risk-based approach. In this webinar we discuss the revision in terms of temperature and humidity calibration in life science environments.

In this webinar you will learn:

  • How to decide if ISO 17025 is a requirement for your application, or if ISO 9001 calibration is sufficient.
  • How to deal with the revision’s new requirement for clear definitions for specifications and decision rules.
  • How to use risk assessment as a tool to decide which standard to follow for calibrations in regulated environments.

Presentation PDF

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Speakers

Daniel Soave

Daniel Soave

Daniel Soave
Technical Support Service Manager

Daniel Soave is a Process Quality Engineer and has been a Quality Manager for Vaisala. He is currently the Technical Support Manager for Vaisala’s continuous monitoring product in North America. Daniel is also responsible for developing, maintaining and improving the quality management systems in Vaisala’s Boston calibration lab, with special focus on ISO9001, ISO14001, OHSAS18001 and ISO17025.

Paul Daniel

Paul Daniel

Senior Regulatory Compliance Expert
Email
[email protected]

Paul Daniel is the Senior Regulatory Compliance Expert at Vaisala. He has worked in the GMP-regulated industries for over 20 years helping manufacturers apply good manufacturing practices in a wide range of qualification projects. His specialties include mapping, monitoring, and computerized systems.

At Vaisala, Paul oversees and guides the validation program for the Vaisala viewLinc environmental monitoring system. He serves as a customer advocate to ensure the viewLinc environmental monitoring system matches the demanding requirements of life science and regulated applications.

Paul also shares his GMP experience through regular blog contributions, webinars, and seminars around the world. Paul’s expertise in the demanding GxP world is applicable to any industry where measurement is critical to product quality. Paul is a graduate of University of California, Berkeley, with a bachelor's degree in biology.

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