HCR 577 Summary Group 4 Project 2
HCR 577 Summary Group 4 Project 2
Summary Module 5: Group Assignment: Project Management Steps to Ensure a Successful Submission
- Due Thursday by 11:59pm
- Points 100
- Submitting a file upload
- Available Mar 18 at 12am – Apr 17 at 11:59pm
Your team (same groups as the country presentation) is responsible for the project management of the submission your company’s NDA to FDA. The market for your drug is highly competitive therefore meeting the timelines is critical. Prepare a timeline and assign roles and responsibilities to specific team members, as listed.
- Quality Control
- Validation Engineering
- Formulation
- Manufacturing
- Regulatory
- Quality Assurance
- Facilities
- Logistics
For Week 5, prepare a presentation to share with the development team. Show in the slides how this approach would be successful.
Provide 3-5 topics / questions where the FDA may request additional information and how you would manage this request.
Summary
Prepare a 1 page summary, ADA style, for your proposal to be submitted with your presentation. Submission to FDA: Dec 2027
Rubric
Group PowerPoint & Summary (1)
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Criteria
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Ratings
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Pts
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This criterion is linked to a Learning OutcomePowerPoint
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50 ptsExcellentPowerPoint presentation has a cover sheet, 1 slide with recommendation, 3-4 slides discussion, 1 slide conclusion, 1 slide with references.
35 ptsGoodany 1 of these missing: PowerPoint presentation has a cover sheet, 1 slide with recommendation, 3-4 slides discussion, 1 slide conclusion, 1 slide with references.
15 ptsNeeds Improvement2 or more missing: PowerPoint presentation has a cover sheet, 1 slide with recommendation, 3-4 slides discussion, 1 slide conclusion, 1 slide with references.
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50 pts
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This criterion is linked to a Learning OutcomeSummary Format
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20 ptsExcellentFollows APA format, spelling and grammar correct with no more than 2 errors.
10 ptsGoodFollows APA format, spelling and grammar appropriate with no more than 3 – 5 errors.
5 ptsPoorDoes not do or does not following instructions and does not meet requirements.
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20 pts
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This criterion is linked to a Learning OutcomeSummary Content
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30 ptsExcellentProvides a detailed summary of product and supports with 3 or more references, one of which must be from the ASU library. Meets 1 page requirement.
15 ptsGoodGeneral description that covers points, includes at least 2 references, one must be from the ASU library. Meets 1 page requirement.
0 ptsPoorDoes not do or work turned in does not meet assignment requirements. Does not meet 1 page requirement, either too long or too short.
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30 pts
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Total Points: 100
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