Pharmaceutical Regulatory Affairs & Quality Operations (RAQ)

Work Term Option (RAQC)

Start in January, May, September

Study Option

Full-time & Part-time

Credential

Ontario College Graduate Certificate

School

School of Biological Sciences & Applied Chemistry

Courses

Delivery

At Seneca, courses are delivered in the following formats: online, in-person, hybrid (an online, in-person combination) or flexible (offered in-person and online at the same time).

The chart below outlines the delivery options available for each course in this program. For some academic terms, there may be more than one delivery option available. You’ll be able to select your preferred options when building your course schedule during open enrolment.

Preferences for course delivery will be considered on a first come, first served basis.

Part-time students are recommended to enroll in WTP100 one to two terms before beginning a co-op or work term.

Important: Students must be enrolled in the WIL stream of their program before registering for WTP100. If you are not yet in the WIL stream, please review eligibility requirements for more details.

Semester 1

Course Code	Course Name	Winter	Summer	Fall
PBB814	Biotechnology and Biopharmaceuticals	Flexible Online	Flexible Online	Flexible Online
	This subject 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.
PFM714	Product Formulation and Manufacturing	Flexible Online	Flexible Online	Flexible Online
	This subject covers the cGMPs, how they were developed 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.
PQA711	Introduction to Quality Assurance	Flexible Online	Flexible Online	Flexible Online
	This subject 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 hires them.
PRA700	Introduction to Pharmaceutical Regulatory Affairs	Flexible Online	Flexible Online	Flexible Online
	This subject 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.
TWC713	Technical Writing and Communication I	Online	Online	Online
	TWC713 is a post-diploma technical writing course designed to expose students to the different types and techniques of writing that are used within the Pharmaceutical Regulatory Affairs and Quality Assurance fields. Emphasis throughout will be placed on the rhetorical strategies underlying effective prose.
WTP100	Work Term Preparation	Online	Online	Online
	This Work Term Preparation course is designed to empower students with the tools, skills, and strategies needed to navigate the modern job market and achieve long-term career success. Through self-assessment, career exploration, helping students to identify and leverage skills from their existing experiences, students will develop a deep understanding of their personal strengths, values, personality, interests and goals. The course covers essential topics such as crafting professional résumés and cover letters, mastering interview techniques, and building a strong personal brand, including an online presence. Students will learn how to research career pathways, evaluate job market trends, and create actionable career plans tailored to their aspirations. Emphasis is placed on professional communication, networking, workplace readiness, and adapting to diverse organizational cultures. Additionally, the course provides insights into negotiating job offers, managing career transitions, and professional growth. With a focus on lifelong learning and continuous improvement, this course equips students with the confidence and resources to pursue fulfilling careers while remaining adaptable in a dynamic and competitive workforce. Ideal for students preparing to enter the job market or those seeking to refine their career trajectory, this course fosters self-awareness, professional readiness, and strategic career planning.

Work-Integrated Learning Term

Course Code	Course Name	Winter	Summer	Fall
RAQ441	Pharmaceutical Regulatory Affairs, Work Term	Hybrid Online In-person	Hybrid Online In-person	Hybrid Online In-person

Semester 2

Course Code	Course Name	Winter	Summer	Fall
IRA815	International Regulatory Affairs and Harmonization	Flexible Online	Flexible Online	Flexible Online
	This course provides students with an overview of Pharmaceutical regulations in European countries, Japan and USA as well as the regulations in a selected number of other geographic locations are examined to understand the reasons behind regulations and controls in these areas. A review of the purposes of international harmonization and its impact is discussed. The importance of International Regulatory Affairs in global formulation and strategy is also explored.
PCR901	Introduction to Clinical Research	Flexible Online	Flexible Online	Flexible Online
	This subject introduces students to the basic concepts in clinical research and the clinical trial regulatory environment in Canada.
PEC715	Pharmacoeconomics	Flexible Online	Flexible Online	Flexible Online
	This subject provides students with an introduction to the use of pharmacoeconomic evaluations in health care. The subject 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.
PQA811	Quality Assurance II	Flexible Online	Flexible Online	Flexible Online
	This subject describes the role and responsibilities of the Quality Assurance (QA) 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 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.
PRA800	Regulatory Affairs II	Flexible Online	Online	Online
	This subject 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.

Program Learning Outcomes

Learn more about program learning outcomes for this program.

Archived Program & Course Information

To find details on programs or courses from prior academic years, browse our archive of program information.

Pharmaceutical Regulatory Affairs & Quality Operations (RAQ)

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