Applied Out of Specification (OOS) Results Investigation

This live, instructor-led course provides a pragmatic and practical guide to the process of investigating atypical and out-of-specification results in a GMP-compliant laboratory.

The course covers how to systematically investigate atypical and out-of-specification results.

You will learn how to plan and undertake an investigation within the constraints of a GMP-regulated environment.

The course covers how to investigate a hypothesis, 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.

Duration: 6.5 hours over 2 days.
Virtual classroom course price: £510 + VAT per delegate.

This course is taught live in a virtual classroom and offers a fully interactive experience, with case studies to reinforce the knowledge and apply the topics learned. Delegates can ask live questions; either by using their microphone or by typing into the chat box.

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