Applied Out of Specification (OOS) Results Investigation

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Course summary

  • Duration: 1 day for face-to-face | Total of 6.5 hours for Virtual Classroom course
  • Experience level: Advanced
  • Type: Universal, applicable to all disciplines
  • Teaching method: Face-to-face OR online via live video, with case studies
  • Scheduled course venue: The Open University | Other venues | Virtual Classroom
  • Online/onsite/in-house/offsite availability: Arrange this course just for you
  • Scheduled course price: £510 + VAT per delegate
  • Course discount: RSC and CAMS members receive a discount on this course*

What will you learn on this course?

This is a pragmatic and practical guide to the process of investigating atypical and out-of-specification results in a GMP-compliant laboratory.

  • What is the difference between Out of Specification, Out of Trend, and Atypical results?
  • How do you systematically investigate Out of Specification results?
  • What is the consequence of not following the prescribed systematic procedure?
  • How do you investigate a hypothesis?
  • How do you assign a root cause?
  • What action do you take?

Learning outcomes

  • You will learn how to plan and undertake an investigation within the constraints of a GMP regulated environment
  • You will understand the need for a pre-defined, sequential, investigation process
  • You will understand the adverse consequence of not following the pre-defined process
  • You will be able to plan and conduct an investigation into an OOS result
  • You will be able to propose and test hypotheses, assign a root cause, and propose and implement appropriate corrective and preventative actions

Who is this course for?

This course is ideal for laboratory analysts who are interested in practical ways to comply with GMP requirements, or for compliance managers who want a broad understanding of laboratory QA systems. Although this course is not technique-specific, and applies to both chemical and microbiological analysis, the worked examples assume knowledge of the principles of gas chromatography or liquid chromatography (or have attended the Complete GC & GC-MS or the Practical Essentials of GC & GC-MS; or the Complete HPLC & LC-MS or the Practical Essentials of HPLC & LC-MS) and familiarity with common laboratory terminology. Previous experience of working to GMP is not essential.

How to book this course

Feedback from previous attendees

"It felt personal and friendly! (The most interesting topic was the) Phase II investigation stage." Laboratory Manager (Bespoke training, December 2023).

"Great! (I enjoyed) all."  Mohammed Alharbi, Senior Pharmacist, Saudi Food & Drug Authority, Saudi Arabia (Bespoke training, December 2018).

"(I enjoyed) the course discussions."  (Bespoke training, December 2018).