It is a fundamental expectation and requirement that the results delivered from laboratory analysis and test are both reliable and can be trusted to reflect the actual finding of the laboratory work. In the heavily regulated pharmaceuticals sector the integrity of quality control laboratory data has attracted significant regulatory scrutiny since the Able Laboratories scandal in 2005. Despite this, incidences of unreliable, untrustworthy and even fraudulent laboratory data are still being uncovered as evidenced by the number of warning letters issued by the US Food and Drug Administration and the Ranbaxy Consent Decree. A training Course on this subject is clearly needed.
Laboratory Data Integrity is an on line electronic learning course that seeks to achieve four objectives:
1. Discuss the practices that may gave rise to the unreliable data, including some actual case studies
This will identify the practices, factors and happenstances that can compromise the reliability of laboratory data. This will include a discussion of available information of actual incidences of submission of unreliable data, such as FDA 483 observations, Warning Letters and Establishment Inspection Reports.
2. Consider the consequences of unreliable analytical data
This section will look at some of the potential and actual consequences of a laboratory releasing unreliable data. This will include potential consequences for the patient, the company releasing the data and also for the individual laboratory and management staff involved.
3. Discuss how to assure the reliability of analytical data in the student’s laboratory
This section will look at the activities that should be performed by the student in their laboratory to provide a high degree of assurance that the results they deliver are reliable and trustworthy.
4. Discuss how to detect potentially unreliable scientific data
This section will discuss the steps that can be taken by the customer or client to detect potentially unreliable analytical data.
This course is primarily intended for all those who perform, manage or assure the quality of laboratory testing or analysis. 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