Training activity information
Details
Audit the processes for handling of laboratory data and test results and make recommendations for improvements including the following:
- Creation of test reports
- Creation of Certificates of Analysis or Certificates of Conformity
- Data integrity, in particular the use of second checks
Type
Developmental training activity (DTA)
Evidence requirements
Evidence the activity has been undertaken by the trainee​.
Reflection on the activity at one or more time points after the event including learning from the activity and/or areas of the trainees practice for development.
An action plan to implement learning and/or to address skills or knowledge gaps identified.
Considerations
- Pharmaceutical quality system requirements
- Accreditation requirements
- Information governance
- Data integrity
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 5 |
Outcome
Investigate questionable laboratory results or out of trend results following quality system requirements, liaising with analysts, supervisor and customers where appropriate. |
| # 7 |
Outcome
Describe the requirements of data integrity related to quality control systems. |