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Instrument Qualification for a Quality Management System

C.E. Credits: P.A.C.E. CE Florida CE
Speaker

Abstract

For laboratories that operate within quality management systems for compliance with global standards such as ISO 9001, ISO 13485, ISO 17025, ISO 15189, GxP, etc. and other country-specific regulations, documented verification that laboratory instruments or equipment are installed, operating, and performing according to the manufacturer’s specifications for the design's intended use is a requirement. Developing and performing these tests on your own can be complex, time-consuming, costly, and challenging to complete. A properly planned and scoped compliance initiative and process validation engagement is more flexible than a reactive engagement due to non-compliance. By providing peace of mind through manufacture offered testing and documentation to help ensure that instruments and equipment are working and producing accurate data, qualifications are important to every laboratory, even those not operating in a regulated environment.

In this webinar, you’ll hear about the importance of qualification protocols as documentation, their value in process validation, and the importance of maintaining a quality system.


Learning objectives:

  • Summarize where a qualification comes from  
  • Explain what process validation is and how a qualification (IQ/OQ/PQ) fits
  • Discuss what qualifications (IQ/OQ/PQ) provide, how they are organized, and when they are required 
  • Review why instrument and equipment qualifications are important to process validation
  • Compare what is included in a qualification from Thermo Fisher Scientific and where they are applicable

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