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Pharmaceutical Quality Assurance & Regulatory Affairs

This program provides students theoretical and practice knowledge of Quality Assurance and Regulatory affairs and apply the knowledge and skills to the product development and manufacture and the maintenance of regulatory compliance.

Program Length

28 weeks (560 hours) instructor-led full-time training

Financial Aid

Free financial consultation available. Financial aid may be available to those who qualify.

Program Description

Quality Assurance is critical to the success of product development and manufacture and the maintenance of regulatory compliance. This course is designed to provide participants with extended knowledge of Quality Management, Quality Assurance and Quality Control and to highlight the challenges associated with QA in the pharmaceutical field. In this course, it clarifies the roles and expectations of Quality Assurance throughout the entire process, from development through audits and inspections. Students will gain a wide range of knowledge of quality assurance guidance: GMPs, GLPs, ICH, GDPs, how to write SOPs, do an investigation, product complaints, product recall, returned goods, change control and CAPA.

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In this program, it offers specialized knowledge required as regulatory affairs professionals who work in Pharmaceutical, biotechnology, medical device and food companies. This course will give participants the skills necessary to work with regulatory agencies worldwide from conducting clinical trials overseas to filing efficient, compliant submissions with foreign regulators. The primary focus is on regulatory affairs in North America under the Canadian Health Products and Food Branch (HPFB) and the US Food and Drug Administration (FDA), but it also discusses the regulations in Europe, Japan and Australia. In an increasingly global market, understanding of global regulations is more important than ever.

Admission Requirements

Degree in science, health science, pharmacy or similar fields. Or a diploma with experience in clinical research or regulatory affairs

Career Opportunities

The Pharmaceutical Regulatory Affairs and Quality Assurance Program focuses on knowledge of regulatory strategic considerations and principals and practices of pharmaceutical quality assurance. After the completion of the program students will be eligible to apply in the following industries:

  •  Pharmaceutical companies
  •  Food products industry
  •  Chemical products industry
  •  Federal and provincial governments
  •  Clinical Research Organizations
  •  Environmental Laboratories
  •  Cosmetic industry
  •  Natural health product companies
Read Job Responsilities – Please Read More
  • Develop and conduct programs of sampling and analysis to maintain quality standards of raw materials, chemical intermediates and products
  • Conform to applicable SOP’s, GMP and GLP requirements
  • Ensure that a company’s products comply with the HPFB, FDA and ICH regulations regulations
  • Develop and maintain strict compliance (policy guidelines, development of a standard compliance program & current Good Manufacturing Practices)
  • Keep abreast of international legislation, guidelines and customer practices
  • Undertake and manage regulatory inspections
  • Connect different information to improve operational efficiency & performance and good communication with FDA performing an active role in hosting an FDA inspection
  • Review company practices and provide advice on changes to systems
  • Interpret quality-related requirements to drug substance (synthesis, characterization, impurities) and drug product
  • Develop specifications (substance, product) and to improve documentation for pre-clinical and clinical work
  • Examine requirements and critical issues regarding non-clinical studies
  • Summarize all major steps and elements to the drug development process and to demonstrate the ability to communicate in professional terms about the drug development process
  • Submit license and clinical trials applications to authorities to strict deadlines


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