Training activity information
Details
Evaluate the departments ongoing stability testing strategy against regulatory guidance and suggest improvements
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
Considerations are suggestions about what may be useful for the trainee to think about while undertaking a training activity. They should not be considered as a mandatory checklist. Trainees should not be expected to demonstrate or provide evidence for each of the considerations listed.
- Quality risk management principles
- Appropriateness of sampling and testing strategies
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 |
Outcome
Apply the principles of good manufacturing practice (GMP) to the development of new products. |
| # 6 |
Outcome
Apply the principles of quality risk management to the manufacturing process. |