HCR 577 Group 4 assignment 2
HCR 577 Group 4 assignment 2
Module 5: Group Assignment: Project Management Steps to Ensure a Successful Submission
- Due Apr 16 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
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