Quality Assurance and Regulatory Affairs Diploma

Pharmaceutical Science College of Canada
Toronto, Ontario, Canada

Course Format: Classroom | E-learning | Virtual Class | Online/Live | On-site/In-house | Blended | Self-paced

Course Description:

'' The 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/QC in this environment. Quality Assurance is critical to the successful development and manufacture of products and the maintenance of regulatory compliance. This course 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 investigation, product complaints, product recall, returned goods, change control and CAPA.

This program is a unique in offering specialized knowledge required to help biotechnology, medical device, pharmaceutical, and food companies. This course will give participants the skills necessary to work with regulatory agencies world wide �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 (HPFIB) and the US Food and Drug Administration (FDA), but as well as the regulations in Europe, Japan and Australia. In increasingly global market, understanding of global regulations is more important than ever.
...''

Elements of this syllabus are subject to change.

Phone:+1 416 821 4876 / 647 996 5876

School Address/Venue(s):

505 Consumers Road, Suite 500
Toronto, ON Canada M2J 4V8

Jobs & Resumes: Toronto
Houses & Roommates: Toronto
Travel Agencies: Toronto

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