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Assessing Validation Data in Cannabis Testing Labs

Guest speaker: Halima Alli, Technical Program Manager-Medical/Quality Compliance Manager, Perry Johnson Laboratory Accreditation, Inc.

Regulations governing the cannabis industry vary from state to state, so testing labs have to walk a fine line when it comes to compliance and accreditation. Among the unique challenges these moving goal posts present is assessing validation data, particularly as it pertains to ISO/IEC 17025.

Although the performance and technology for commonly-used testing methods are well documented for a variety of applications, the data may not include the particular sample matrices encountered in laboratories performing cannabis testing. An existing method may require modifications to achieve the level of performance required for a particular regulation. Laboratories also have the flexibility to develop their own methods. In both instances, the lab needs to validate a testing method. When that lab is accredited to ISO/IEC 17025, that validation has to meet the requirements of the standard.

Takeaways:

  • Highlights of the ISO/IEC 17025 requirements for the validation of methods
  • Setting acceptance criteria based on the intended use of the results
  • Recording and analyzing results for test method validations
  • Documenting validation activities to demonstrate conformance to the standard
  • How an electronic QMS like Qualtrax can help

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About the Presenters

Halima Alli is the Technical Program Manager for the accreditation of clinical testing laboratories and lends her expertise to general testing program activities at Perry Johnson Laboratory Accreditation. She brings both clinical laboratory and medical device industry expertise to the PJLA technical program and quality management teams. As a medical technologist at the bench and providing technical and application support, strong quality systems and regulatory compliance programs were always central to success in the laboratory.

Karen Arrivillaga has been with Qualtrax since 2015, with a focus in the laboratory space. Karen has more than six years of experience selling technology solutions and is passionate about finding the best ways to use software to manage accreditation, simplify compliance, and inspire a culture of quality. She’s a proud member of the Qualtrax internal audit team, which recently assisted with our transition to ISO/IEC 9001:2015. Karen graduated from Virginia Tech with a Bachelor’s in Consumer Economics.

Category: Cannabis Labs