Pharmaceutical Regulatory Affairs and Quality Operations
|Duration:||2 semesters (1 Year)|
|Start Dates:||Summer, Fall, Winter, |
Start dates are subject to change
|Credential Awarded:||Ontario College Graduate Certificate|
In RAQC, you’ll gain a foundational understanding of the areas of regulatory affairs and quality operations. Through studies of regulatory compliance in Canada and in other areas of the world, you’ll be prepared for occupations involving drug or medical device submissions and quality assurance functions and roles.
The first semester will provide you with the fundamentals required in both regulatory affairs and quality operations. Introductory level courses equip you for the co–operative work–term placement, which occurs between semesters and gives you the opportunity to apply the knowledge learned in the first semester. Your work–term provides you with valuable industry exposure.
The second semester will provide more detailed and specific exposure to the areas of regulatory affairs and quality operations.
- A recognized degree from an accredited institution in science with a focus on chemistry, biology or pharmaceutical studies.
- English proficiency at the college level.
- All eligible applicants will be required to attend a mandatory orientation session where they will complete a $55 pre-admissions test, a questionnaire, and/or Applicant Profile. These assignments will be assessed for content, writing skills, writing effectiveness, and style. A pamphlet with your testing information is available here.
- Applicant selection will be based on the assessment of the above assignments, academic credentials, and English proficiency.
- In some instances, an interview may be required.
The Importance of Learning Skills:
Student success in college requires well developed learning skills (such as being able to work independently, participate in a team, be well-organized, develop good work habits, and show initiative). These skills are as important as prior academic achievement. While it is expected that applicants would have developed these skills through previous education and life experiences, Seneca offers support to assist students with further development of these important skills. Seminars, workshops and tutoring are available at Seneca's Learning Centres.
Focus your career by specializing in Pharmaceutical Regulatory Affairs and Quality Operations. With your one–year graduate certificate, you’ll be prepared for such dynamic careers as Regulatory Affairs Associates, Regulatory Affairs Assistants, Quality Assurance Associates, Quality Assurance Investigators, Documentation Administrators and Medical Information Associates in the pharmaceutical, biotechnological, veterinary, cosmetic and food industries.
All students are required to follow guidelines, policies and procedures set down by the School of Biological Sciences and Applied Chemistry.
Affiliations and Associations
- Canadian Association of Professional Regulatory Affairs (CAPRA)
- Drug Information Association (DIA)
- Pharmaceutical Sciences Group (PSG)
- Regulatory Affairs Professional Society (RAPS)
The co-operative education component provides you with the opportunity to secure a paid work term between academic semesters.
Job-related employment enables you to combine classroom skills and on-the-job training.
|Co-op Model - September Start|
|Semester 1||Work Term||Semester 2|
|Co-op Model - January Start|
|Semester 1||Work Term||Semester 2|
Diploma to Degree... and Beyond
Through transfer agreements and institution partnerships, graduates of this Seneca College program may be eligible for credit at the following post-secondary institution(s):
|Davenport University||• Any relevant Bachelors or Master of Business Administration|
|Semester 1||Course Name||Hrs/Wk|
|PBB814||Biotechnology and Biopharmaceuticals||4|
|PFM714||Product Formulation and Manufacturing||3|
|PQA711||Introduction to Quality Assurance||4|
|PRA700||Introduction to Pharmaceutical Regulatory Affairs||7|
|TWC713||Technical Writing and Communication I||3|
|CPP100||Co-op Professional Theory (co-op option only)||1|
|CWT100||Co-op Work Term (co-op option only)|
|Semester 2||Course Name||Hrs/Wk|
|IRA815||International Regulatory Affairs and Harmonization||3|
|PQA811||Quality Assurance II||4|
|PRA800||Regulatory Affairs II||6|
|PCR901||Introduction to Clinical Research||3|
|CPP200||Co-op Professional Practice (co-op option only)||1|
|For more information, please visit our website at: http://biochem.senecacollege.ca.|
|Domestic Admissions Advisor:||Carsten Wuertz
Telephone: (416) 491-5050 Ext. 22803
|International Admissions Advisor:||Ida Yee
Telephone: (416) 491-5050 Ext. 22405
|Registration & Records Advisor:|
Telephone: (416) 491-5050 Ext. 33006
|Student Advisor:||Monica Russell
Telephone: (416) 491-5050 Ext. 33769
|Program Coordinator:||Tom McLerie
Telephone: (416) 491-5050 Ext. 33245
|Co-op Coordinator:||Zahra Hirji
Telephone: (416) 491-5050 Ext. 33218
|Program Chair:||Paola Battiston
Telephone: (416) 491-5050 Ext. 33760