FDA Considers New Quality Metrics

FDA Seeking Industry Input on Quality Metrics to Help Rationalize Its Review and Inspection System | IPQ Newsletter:

"Based on its review of all the responses submitted on the metrics issue, FDA has chosen three that it is considering using and is seeking additional feedback on:

• batch failure rate
• right first time, and
• out-of-specification (OOS)/laboratory failure investigation rates"

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ISO 17025: Calibration Laboratories - Onsite Training Class

If you need to understand the expectations of a metrology lab from the global perspective, and not just from the US perspective, then you need this course:

 ISO 17025: Calibration Laboratories - live on-site training by SkillsPlus International Inc.

In this class, you'll learn the details of ISO 17025 as it relates to calibration laboratories. This class is instructor-led, and taught on-site in-plant, at client locations.

Upon class completion, students will be able to:

1. Explain the rationale for ISO 17025. 
2. Explain the management requirements from a regulatory perspective. 
3. Explain the technical requirements from a regulatory perspective.

For more information, and to view a list of the topics covered, visit:

 ISO 17025: Calibration Laboratories - live on-site training by SkillsPlus International Inc.

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• 2012 Onsite cGMP & QSR Compliance Courses by SkillsPlus Intl Inc. (skillsplusinfo.blogspot.com)