At the conclusion on the webinar attendees will be able to:
1. Recall the historical development of USP <797>
2. Recognize the types of pharmaceutical preparations to which it applies
3. Differentiate between Category 1, 2, and 3 preparations
4. Recognize changes that apply to Personnel Management
5. Recognize changes that apply to Facility Management
6. Recognize changes that apply to Sterile Preparation Management
7. Recognize changes that apply to Quality Management
8. Describe how these changes can be applied to BUD of formulations
9. Evaluate variables involved in implementing change in their practice
10. Identify the testing requirements outlined in the new version of USP <797> for establishing and extending BUDs, and for batch release
11. Describe some of the microbiological, biological, and analytical tests utilized in the extension of BUDs for CSPs
12. Describe a stability study design where all design factors are tested at all time-points, and recognize where a reduced study design may be implemented.
13. Recognize the importance of testing the CSPs to ensure the safety and efficacy of the products through the BUD