- Number of days: 1
- Experience level: Advanced
- Type: Generic, applicable to all instrumentation
- Teaching method: Face-to-face classroom with practical exercises
- Course venue: This course is run on demand - please contact us to book
- Onsite/offsite availability: Arrange this course just for you
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 a Reportable Value?
- 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?
- 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 moving into a GMP-regulated environment or into a Quality Assurance role, or for pharmaceutical regulators or 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 an advantage, but not essential.
Feedback from previous attendees
"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).
This course is run on demand - please contact us to book.