When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence.
This course will provide a detailed walk through of how to conduct a laboratory investigation. We will explore events and circumstances that may trigger laboratory investigations, what steps you can take to identify the root causes and build an action plan for correcting and preventing further instances.
This course can be booked on an individual or group basis. If you are interested in training for you or your organisation, please contact training@towermains.com.
✔ Importance of laboratory testing specifications
✔ Identifying an issue and the need for an investigation
✔ How to conduct a good investigation
✔ Investigative tools
- Root Cause Analysis (RCA)
- Failure Mode and Effect Analysis (FMEA)
- Laboratory Investigation Checklist
✔ MHRA phases of investigation
✔ Corrective and Preventative Actions
This course would be beneficial for individuals who are:
✔ Laboratory staff who are responsible for – or interested in – troubleshooting unexpected data
✔ Managers who are responsible for running a laboratory, be it clinical, research or other
✔ QA staff or sponsors who are interested in understanding the investigative methods used by the laboratory
✔ Current and prospective laboratory staff wishing to extend their skill set
1 day
The course is delivered to groups of up to 20 learners and broken down into four modules:
Topic 1: Importance of laboratory specifications
- The importance of laboratory testing specifications
- Recognising laboratory related problems
- Identifying the need for an investigation
Topic 2: Conducting a good investigation
- What controls are in place?
- Who is responsible?
- Who are the stakeholders?
- Communication
- Critical and balanced thinking
- Investigative tools
- Laboratory investigation checklist
- Root cause analysis
- Failure mode and Effect Analysis
Topic 3: MHRA phases of investigation
- Phase I
- Phase II
- Phase III
- Examples of real-life investigations
Topic 4: Action plan
- Corrective and Preventative actions
- Collaboration and Communication
- Documenting and reporting
These modules consist of a mixture of presentations and individual and interactive group exercises.
An electronic certificate of attendance will be issued to each delegate.
If you are interested in booking a future course, please contact Erin Bell to register your interest.
Testimonials
“Easy to follow, very clear explained, entertaining, which is very helpful because the subject is sometimes heavy to digest.”
“I enjoyed the course immensely, the anecdotes made us laugh and helped make the content memorable. The experience and expertise of the presenters were clear and they promoted a friendly, open discussion where everyone was able to ask questions.”
“Really lovely style, laidback, friendly, informative. Great tutor.”
“Andrew Waddell has a very good relationship between him and us as audience. He was able to capture my interest during the whole course. Thank you.”
