Training activity information
Details
Review a completed stability testing protocol for regulatory compliance and acceptability of risk-based approach including the allocation of shelf-life
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
- Method validation
- Duration of study
- Calculation of shelf-life
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 4 |
Outcome
Write specifications for routine quality control and stability assessment based on relevant standards and guidance. |
| # 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. |