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Learning objectives

Dosage Form Design II PR3102 Self-Directed Learning Component Department of Pharmacy National University of Singapore. Learning objectives. To research, appreciate, and critique topics relevant to aseptic manufacturing Develop skills on literature evaluation and oral presentation

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Learning objectives

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  1. Dosage Form Design IIPR3102Self-Directed Learning ComponentDepartment of PharmacyNational University of Singapore

  2. Learning objectives • To research, appreciate, and critique topics relevant to aseptic manufacturing • Develop skills on literature evaluation and oral presentation • Cultivate teamwork

  3. Approach • Number of Students: 125 • Number of Projects: 7 • Number of Students per group: 6* • 3 groups presenting on each topic • Allocation • Group members • Project title • Presentation sequence within each topic

  4. Assessment • 2,000 word report • ALL groups to submit by 8 Oct 2010 • 15min Presentation + 5 min Q&A • Review by subject matter experts • Continuous assessment on ALL 7 topics • MCQ or short questions • 9 Nov 2010

  5. Dosage Form Design II Lectures

  6. Presentation • Slides made available to class • Presentation and division of workload • Number of speakers • Coherence! • Criteria for assessment • Clarity of presentation • Accuracy of information • Ability to convey relevant knowledge • Presentation skills

  7. Group report • Coverpage • word count, title of the project, names and contribution of the group members • Division of workload • Coherence! • Basis of CA2 • Plagiarism • http://www.cit.nus.edu.sg/plagiarism-prevention • Consequences

  8. Topics Topic 1: Aseptic Facility Design Design considerations in the structural components in the aseptic facility Topic 2: Packaging of vaccines Container-closure system: selection and consideration Rubber closures: Tests and standards Topic 3: Sterilization indicators Overview of sterilization indicator, comparisons between types of indicators and its uses Topic 4: Validation of Aseptic Manufacturing Overview of validation of aseptic operations, purpose and concepts Topic 5: Validation of Aseptic Room Garments Purpose, tests used in validation Topic 6: Facility Monitoring: Viable Particles Purpose/principles, methods for monitoring Topic 7: Facility Monitoring: Non-viable Particles Purpose/principles, methods for monitoring

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