Description
Programme Pathway / Structure
The programme integrates core taught modules (24 credits) with a capstone research project or thesis (6–9 credits). All requirements are completed within two intensive terms over 6–9 months.
| Code | Course Title | Credits | Content Summary |
| CBA 701 | Pharmaceutical Quality Systems & GMP Compliance | 3 | Overview of Health Canada, EMA, and FDA GMP frameworks; documentation and process validation. |
| CBA 702 | Regulatory Affairs & Product Registration | 3 | Global regulatory submissions (NDS, ANDA, CTA) and ICH Q-series guidelines. |
| CBA 703 | Manufacturing Technology & Process Validation | 3 | Sterile/non-sterile manufacturing, process design, cleaning validation, and continuous improvement. |
| CBA 704 | Analytical Quality Control & Risk Management | 3 | Application of ICH Q9 risk management and analytical method validation. |
| CBA 705 | Auditing, Inspection, & Compliance in Pharma | 3 | Internal/external audits, data integrity, CAPA, and mock inspections. |
| CBA 706 | Biopharmaceuticals & Advanced Therapies Regulation | 3 | Regulation of biologics, vaccines, ATMPs, and gene therapies. |
| CBA 790 | Research Methods & Applied Data Analysis | 3 | Research design, data interpretation, scientific writing, and regulatory documentation. |
| CBA 799 | Master’s Thesis / Industry-Based Research Project | 6–9 | Applied research on QA or regulatory issues; includes thesis and oral defense. |
Credit Distribution Summary
| Component | Credits |
| Taught Modules (6–7 Courses) | 21–24 |
| Research Methods | 3 |
| Master’s Thesis / Project | 6–9 |
| Total | 30–36 |
Delivery & Schedule
- Full-Time Accelerated Mode: 6–9 months (2 intensive terms)
- Format: Blended (on-campus + online components)
- Learning Methods: Lectures, case studies, regulatory simulations, lab demonstrations, and capstone projects
| Term | Courses | Credits |
| Term 1 (Months 1–4) | CBA 701, CBA 702, CBA 703, CBA 704 | 12 |
| Term 2 (Months 5–9) | CBA 705, CBA 706, CBA 790, CBA 799 (Research Project) | 18–24 |
Entry Requirements
- Honours Bachelor’s degree (minimum GPA 3.0/4.0) in Pharmacy, Chemistry, Biotechnology, or Life Sciences.
- Applicants with 3+ years of relevant industry experience may also be considered.
- English Proficiency: IELTS 6.5 (no band below 6.0), TOEFL iBT 90+, or an equivalent proficiency examination.
- Documents Required: Statement of Purpose, Academic Transcripts, Two References, and Updated CV.
Key Features / Advantages
- Accelerated completion (6–9 months) for working professionals.
- Aligned with Health Canada, FDA, and EMA regulatory frameworks.
- Practical focus on QA systems, auditing, and regulatory documentation.
- Strong industry orientation leading to roles such as QA Specialist, Validation Manager, or Regulatory Affairs Associate.
- Designed for international recognition and seamless credit transfer to North American institutions.
