Josephine Azuka-Oganwu: Regulatory Affairs | Food Science | Quality & Compliance

Welcome to my professional e-portfolio, showcasing selected artifacts and learning outcomes from my Regulatory Affairs Capstone at Humber College.

This portfolio highlights my contributions to the development of draft Health Canada regulatory submission packages for Acetaminophen 500 mg Tablets and Sativex Oromucosal Spray. The selected artifacts demonstrate my development of regulatory writing, product documentation, labeling, document organization, and quality and compliance skills.

Capstone Role: Cover Letter and Product Information Lead

My Regulatory Affairs Capstone Projects

The capstone project involved developing draft regulatory submission packages based on Health Canada’s regulatory requirements and guidance. Our team worked on two projects, detailed below:

Acetaminophen 500 mg Tablets Project

This project focused on a proposed shelf-life extension and label update for Acetaminophen 500 mg Tablets. Explore the detailed regulatory considerations and documentation involved.

Sativex Oromucosal Spray Project

This project involved the development of a regulatory submission package for Sativex Oromucosal Spray, addressing specific Health Canada guidelines for cannabis-based medicinal products.

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