Handling OOS Test Results and Completing Robust Investigations

Part of the GMP Laboratory Control Professional Certification

Duration: 90 Minutes
Course Instructor

Danielle DeLucy, M.S.

$ 295
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

It was the Barr Decision in the early 1990s that first coined the term Out-of-Specification (OOS). Since that landmark case, pharmaceutical companies, both drug and biologicals, have had to perform adequate investigations whenever an OOS result was obtained through laboratory testing. In the nearly 30 years since then, FDA continues to cite companies for not performing an adequate investigation.

This accredited course is designed to provide sound training on how to recognize and investigate atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.

Upon completion of this course, you will be able to:

  • List the responsibilities of Analysts and Supervisors
  • Explain what the FDA looks for in terms of Human Errors
  • Describe when a Full Investigation should be triggered
  • Describe the frequency for Re‐testing and Re‐sampling
  • Implement the corrective and preventive action plans (CAPA)

This training is one part of the 10-course series required for the GMP Laboratory Control Professional Certification Program. Attend this course as part of the certification process or as a stand-along course for personal career advancement and training.

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This course has been developed for professionals responsible for generating or evaluating test results in a regulated environment.

Lab Analysts, Supervisors and Managers in Pharmaceutical or Biological Laboratories, including Quality Control and Quality Assurance will benefit greatly from this training.

Course Instructor


Danielle DeLucy, M.S.

Owner, ASA Training & Quality Consulting LLC

Danielle DeLucy, M.S.’s Courses
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