Pharmaceutical Quality Assurance & Regulatory Affairs

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.

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.

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* All student funding, whether made available privately or through various government branches, is only approved to those who qualify, by the original source of funding. There are many criteria that each candidate must meet to be approved. Schools can only inform you of what may be available.

Pharmaceutical Quality Assurance & Regulatory Affairs

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