It sometimes happens during laboratory testing that out of specification, unexpected and suspect results are obtained or an event occurs which causes a deviation from established laboratory procedures.
These occurrences must be handled in an appropriate manner, which normally includes a documented investigation and appropriate follow up actions which should be documented and approved.
For an investigation to be meaningful it must be thorough, timely, unbiased, well-documented, and scientifically defensible.
In this course on laboratory investigations, we will cover what you need to know about handling out of specification, atypical/suspect test results, and deviations from established laboratory procedures.
What are the Objectives of this Course?
On completion of this course you will be able to:
- Explain the elements of a meaningful laboratory investigation
- Define commonly used terms related to laboratory investigations
- Discuss the applicable cGMP/cGLP regulations and guidance related to laboratory investigations
- Explain the details and significance of the Barr Decision as it relates to laboratory investigations in acGMP/cGLP environment
- Explain the detailed procedure for all phases of conducting and documenting a laboratory investigation
Who Should Take This Course?
The target audience for this program are those who are employed in regulated (current Good Laboratory Practice and current Good Manufacturing Practice) or accredited (ISO 17025) [speak ISO seventeen zero two five] laboratories.
It is recommended that this course forms a component of the core syllabus of the training program for all laboratory staff and managers, and quality assurance personnel; and should be studied during initial induction and periodically thereafter.
Course Modules
This course is divided into 5 modules:
- Module 1: Meaningful Investigations Defined
- Module 2: Regulatory Requirements and Guidance
- Module 3: Barr Decision
- Module 4: Conducting a Laboratory Investigation
- Module 5: Documenting a Laboratory Investigation
