Overview

The Pharmaceutical Regulatory Affairs and Quality Operations Program is a graduate certificate program offered on a part-time basis through the Faculty of Continuing Education and Training.

This program provides students with a basic understanding of the areas of regulatory affairs and quality operations within various industries, including pharmaceutical. Students are prepared for occupations involving drug or medical device submissions and quality assurance functions and roles. The issues of regulatory compliance both in Canada and in other areas of the world are covered.

Information Session

New students are invited to attend an information session.

Career Opportunities

Graduates from this program may pursue careers in the areas of Regulatory Affairs and Quality Operations. Career options include within the pharmaceutical, biotechnological, veterinary and cosmetic industries. Graduates find employment as Regulatory Affairs Associates, Regulatory Affairs Assistants, Quality Assurance Associates, Quality Assurance Investigators, Documentation Administrators and Medical Information Associates.

Graduate Opportunities

For more details on related occupations, job market information and career opportunities, please visit the Government of Canada website.

National Occupational Classification (NOC) - Government of Canada

The National Occupational Classification (NOC) provides a standardized language for describing the work performed by Canadians in the labor market. It gives statisticians, labor market analysts, career counselors, employers and individual job seekers a consistent way to collect data and describe and understand the nature of work.

Entry Requirements

Applicants must have an accredited baccalaureate degree with a focus on Biology, Chemistry or Pharmaceutical Studies and demonstrated proficiency in English. Applicants are selected on the basis of their academic credentials, English proficiency and Applicant Profile. English proficiency must be at the university level. Students who have completed University English courses must still write and successfully pass the English Proficiency Test.

Mandatory English Proficiency Test

EPT001
English Proficiency Test and Applicant Profile
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Students applying to take the RAQ program through the Faculty of Continuing Education and Training must complete the mandatory English Proficiency Test and Applicant Profile. Please register for EPT001 online or call Registration at 416-493-4144, ext. 2. Please allow three hours for your test and RAQ Application profile. The Profile takes about one hour and is completed after the assessment test.

The English Proficiency Test (EPT001) and Applicant Profile is offered once each semester, and must be written and assessed as part of the selection process. Both context and communication skills are assessed, and these in combination with prior academic achievement will form the basis for selection. Students will be notified in 2 or 3 weeks regarding their acceptance into the program through their e-mail provided at the time of the test. Students who are successful will have to register in a Module I course. Module II courses can only be done if the appropriate pre-requisite has been completed.
Note:

  • Students who miss the Mandatory English Proficiency Test will have to wait until the following semester to enroll.
  • Students must bring a copy of their degree, photo ID and a current email address on the night of the English Proficiency Test as well as a pencil, eraser, and pen.

IMPORTANT:
If you are registered to write the EPT001 - English Proficiency Test, you are required to have your foreign degree evaluated either by WES (World Education Services) 416-972-0070, or the Comparative Education Services at the University of Toronto 416-978-2400 ext. 3 and must present the evaluation to the staff on the night of the EPT001 test.

Applicant Selection

All eligible students must complete an Applicant Profile that will be assessed for content, writing skills, writing effectiveness and style. Students are selected into the RAQ program on the basis of their academic credentials, successfully passing an English Proficiency Test and the assessment of the written Applicant Profile.

Prerequisites

It is your responsibility to ensure that program requirements and course prerequisites as outlined are met. Prerequisites are included for your academic protection. Knowledge of the prerequisite material is assumed by your instructor and instruction will proceed accordingly. Students lacking prerequisites not only jeopardize their own ability to succeed but present unnecessary interruption. If you lack appropriate prerequisites (or Transfer Credit for the prerequisite course) you may be asked to withdraw or transfer to a more appropriate course with the risk of academic/financial penalty.


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Curriculum

(10 Courses)

PRA700
Introduction to Pharmaceutical Regulatory Affairs
Availability
 

Prerequisite(s):

Admission to the program

This course describes the role of the Regulatory Affairs department in a pharmaceutical organization and focuses on the "submission process" and the legal requirements that control the process for pharmaceuticals, Natural Health Products and Medical Devices. The regulatory requirements at the various stages in a drug product development from inception through CTD (Common Technical Document) Clinical stage and NDS (New Drug Submission) application to issuance of the NOC (Notice of Compliance) are examined. The control and submission parameters for Medical Devices are discussed.




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PQA711
Introduction to Quality Assurance
Availability
 

Corequisite(s):

PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission

This course focuses on the concept of Quality Assurance/Quality Control, planning and contribution of the Quality Assurance team in an organization. Topics covered include QA/QC theory; documentation for GMPs; SOP theory, writing & reviewing; auditing theory; process deviations and SPC/SQC; complaint-handling and product recall theory; and detailed training on GLPs, GMPs and the ISO Quality Standards.
Students gain significant "hands on" experience in document reviewing and SOP writing/reviewing as well as case study work in process deviation and audit investigations. These skills were intentionally built into the program to provide students with meaningful QA skills that can be applied to their employment activities without a large training investment on behalf of the company who accepts them.




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RWC716
Regulatory Writing & Communications
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Corequisite(s):

PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission

The focus of this course is on communication with peers and the regulatory agencies. Students learn the various kinds of competencies needed to prepare regulatory communications and transact the business of quality assurance by primarily examining the practices used to gather and communicate information and improve organizational effectiveness. Aspects of interpersonal communication, such as the use of interviews and meetings to gather information are explored.




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PFM714
Product Formulation and Manufacturing
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Corequisite(s):

PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission

This course covers the cGMP's, how they came into being and their impact on Formulation and Manufacturing, including the importance of accurate documentation and validation of all processes. Pharmaceutical mixing - mixers, excipients and the principles of how products are mixed to provide good flowing granulations are covered. Solutions, ointments, cream preparation and packaging as well as new novel drug delivery systems (transdermal patches, aerosols, and sub-cutaneous implants) are discussed. Students have the opportunity to propose formulations for products and learn how to troubleshoot problem products using the knowledge they have gained.




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PBB814
Biotechnology and Biopharmaceuticals
Availability
 

Corequisite(s):

PRA700 - Introduction to Pharmaceutical Regulatory Affairs or co-ordinator permission

This course is an introduction to biopharmaceuticals and the application of biotechnology to produce them. Emphasis is on the regulations affecting the development and manufacturing of biopharmaceuticals and how they differ from traditional pharmaceuticals. Topics include: basic principles of biotechnology, large scale biopharmaceutical manufacturing, major differences in the regulatory process between biopharmaceuticals and traditional pharmaceuticals, combination biologics and medical device biologics. Students also explore future technologies employed in the biopharmaceutical and biotechnology industry to develop novel products.




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PRA800
Regulatory Affairs II
Availability
 

Prerequisite(s):

PRA700

This course focuses on the preparation of a drug submission. Students compile the necessary information and complete the necessary application forms for a Common Technical Document (CTD) New Drug Submission (NDS) Module 1 along with the overall plan for the compilation of a submission. There is a class presentation relating to policy application for submissions with possible practical application and possible suggestions for dealing with expected deficiency. Introduction to auditing and the Preapproval Inspection (PAI) for submission approval are discussed and an audit practical exercise performed.




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PQA811
Quality Assurance II
Availability
 

Prerequisite(s):

PQA711

This course describes the role and responsibilities of the Quality Assurance department in a pharmaceutical company. It focuses on: 1) the design of a proper quality control/assurance system to ensure the manufacturing of safe products and satisfy regulatory authorities. All systems, from cleaning to component testing, from product assay to product release are geared to provide the manufacturer documented quality checkpoints on the product; 2) management of the quality assurance systems to provide sufficient and adequate records on all testing, distribution and all other procedures that must be in place.




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PCR901
Introduction to Clinical Research
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Corequisite(s):

PRA700

This course introduces students to the basic concepts in clinical research and the clinical trial regulatory environment in Canada.




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PEC715
Pharmacoeconomics
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Corequisite(s):

PRA700

This course provides students with an introduction to the use of pharmacoeconomic evaluations in health care. The course reviews issues and methods of assessing health care technologies and related programs. Techniques used in pharmacoeconomic evaluations are examined. The application of the assessment of health benefits relative to drug costs in the determination of clinical cost-effectiveness is studied. Procedures for reporting pharmacoeconomic data and critical appraisal of the pharmacoeconomic literature are also considered.




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IRA815
International Regulatory Affairs and Harmonization
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Corequisite(s):

PRA700

This course provides students with a review of the functions and purposes of international harmonization and International Regulatory Affairs. Pharmaceutical regulations in European countries, Japan and USA are examined as well as the regulations in a selected number of other geographic locations. Specification criteria and tests with drug substances and drug products are compared and the reasons behind regulations and controls are examined.




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Program Outcomes

Upon successful completion of this program, students are able to:

  1. Demonstrate an understanding of all aspects of regulatory affairs and quality operations in pharmaceutical manufacturing
  2. Demonstrate an understanding of differences in pharmaceutical regulation internationally and the purpose and impact of  efforts to harmonize them
  3. Apply the regulations which affect the development and submission of pharmaceutical and biopharmaceutical products
  4. Describe the drug development process and the role of clinical trials
  5. Apply techniques used in pharmacoeconomic evaluation to determine the cost-effectiveness of a drug
  6. Validate and document product manufacturing processes
  7. Apply Good Manufacturing Processes (GMPs) and discuss their impact
  8. Troubleshoot pharmaceutical products
  9. Design and manage a quality control/assurance system to ensure the manufacture of safe products which comply with regulations
  10. Complete the documentation necessary for new drug submissions in Canada including responding to deficiencies identified
  11. Gather and communicate regulatory information effectively

OSAP Funding Available

This program is eligible for OSAP funding.

Course load is used by OSAP to determine funding options for programs.

If you are taking 1 - 2 courses at the same time, you may be considered for part-time student grants and loans.

  • 1 course (20%)
  • 2 courses (40%)

If you are taking 3 or more courses at the same time, you may be considered for full-time student grants and loans.

  • 3 courses (60%)
  • 4 courses (80%)
  • 5 courses (100%)

To find out if you qualify and to learn how to apply, please visit the OSAP website.

For information on other awards and financial assistance, please see Financial Aid.

Affiliations and Associations

  • Canadian Association of Professional Regulatory Affairs (CAPRA)
  • Drug Information Association (DIA)
  • Pharmaceutical Sciences Group (PSG)
  • Regulatory Affairs Professionals Society (RAPS)
  • American Society for Quality (ASQ)

Credit for Prior Learning

Prior Learning Assessment

Earn college credits for what you already know!
Prior Learning Assessment is a method of assessing and recognizing learning that is equal to college level learning, but has been gained outside a traditional classroom (through work experience, volunteering, outside study, etc.). If you can prove that the knowledge you have gained meets the outcomes of a Seneca course, then credit will be awarded.

How does the PLA process work?
Prior Learning is demonstrated through a "challenge" process. The process measures learning through a variety of methods which may include tests, portfolio assessment, interviews, demonstrations, essays, and work samples. The method used will be determined in consultation with a Program Coordinator.
For more information and to determine if you are eligible for PLA, please call the Program Coordinator.

The process may take from 6 to 8 weeks.

Note: Not all courses can be challenged. For more information go to PLA website or contact your Program Coordinator.

Transfer Credit (Advanced Standing)

Many students who enter Seneca College will have earned academic credits in post-secondary educational institutions which they may be able to apply toward completion of a Seneca College program.

Requests for Transfer Credit must be for a specific course and must be accompanied by an official transcript and course outline. A minimum grade of "C" (60 percent) is generally required for a course to be considered for Transfer Credit.

Download a Transfer Credit Request form. An official copy of your transcript and applicable detailed course outlines should be attached and submitted. Please note it may take 4 to 6 weeks for a Transfer Credit decision.

More Information

Please visit the Degree and Credit Transfer Office.

Graduation/Convocation

When you meet all program requirements and become eligible for a certificate, diploma, or degree, you must inform the Registrar by completing a Graduation Application form and paying the graduation and alumni fee. Certificates, diplomas, and applied degrees are issued twice a year in the Fall (October) and Spring (June).

For further information including deadlines and fees, please visit the  Convocation website or contact the Convocation Office at 416-491-5050 ext. 77461.

Minimum Performance for Graduation

Students will only be eligible to graduate with a Seneca College certificate or diploma if they have maintained an overall good standing in their current program of study. Students in degree programs will be eligible to graduate when they have obtained an average of C (2.5 GPA) in courses in the main field of study, and an average of C (2.0 GPA) in all other courses.

Residency Requirements

A Faculty of Seneca College may recommended a student for a certificate, diploma or degree only after the student has earned a minimum of twenty-five percent of the credit for that program at Seneca.

Testimonial

Afaf Mousa

Armed with a University degree from abroad and a Canadian College diploma, Afaf Mousa looked for a Seneca College graduate certificate program that would help her get a step ahead in her Canadian job search. She found the Pharmaceutical Regulatory Affairs and Quality Operations program to be just what she needed! Having completed eight of the required courses - including the two quality assurance oriented subjects - in the part-time Reg Affairs program, Afaf responded to a job posting on Seneca's Career Link website and was hired in a QA position! Afaf went on to complete the program (graduating in 2011) while employed as a QA specialist in a local pharmaceutical manufacturing firm.

Afaf encourages her colleagues to take Reg Affairs; she speaks of the highly educated students in the program and the fact that they are all mature, adult learners. She reports that the program is well structured, the faculty very helpful and the material well presented. The part-time nature of the program, she notes, makes it easy for those already working to improve their situation. For those wishing to find a job, she notes that the focus of the program on the regulatory environment, clinical studies, quality assurance, as well as pharmaceutical manufacturing are all vital to finding related employment in the pharmaceutical industry.

Program Contacts

Georgina Ioannou
Program Assistant
Georgina.Ioannou@senecacollege.ca
416-491-5050 ext.22946


Jeevaka Weerasinghe
Part-time Program Coordinator
Jeevaka.Weerasinghe@senecacollege.ca
416-491-5050 ext.22559


Joanne Bonnet
Academic Program Manager
Joanne.Bonnet@senecacollege.ca
416-491-5050 ext.22528


Information Session

New students are invited to attend an information session.