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PREREQUISITE:
Minimum Canadian B.Sc. (or equivalent) or Canadian College Diploma
PROGRAM DURATION:
Approx. 46 Weeks
Schedule:
Monday – Thursday: 9:00am – 3:30pm, Friday: 9:00am – 2:00pm |
The Pharmaceutical Quality Assurance
& Quality Control program combines theoretical
knowledge with hands-on skills in all areas that
impact drug quality. Practical experience is gained
in pharmaceutical quality control, validation of
testing methods and processes, technical writing
skills, regulatory compliance and proper documentation
procedures. Some of the skills obtained during the
program include:
Drug analysis
Method and process validation
Analytical instrumentation (HPLC, GC, Spectroscopy)
Documentation systems
Drug stability studies
Quality and compliance auditing
Good Manufacturing Practices (GMP) and Good Laboratory
Practices (GLP)
FOUNDATION MODULE
The foundation module is designed to provide a background in pharmaceutical sciences and introduce new concepts in pharmaceutical quality control, statistics, regulatory affairs and GMP. A crucial component of the foundation module is the introduction of pharmaceutical ethics and law, which prepares students for dealing with drug regulatory issues and compliance.
CORE
MODULE
This module provides training in pharmaceutical quality assurance and
quality control. Emphasis is placed on:
Drug stability
Manufacturing processes and controls
Documentation and GMP
Auditing
Sampling plans
Method validation
Practical training is provided in analytical techniques and technical
writing, which includes the development of protocols and standard operating
procedures.
ADVANCED MODULE
The advanced module is primarily project based. These projects include
raw material testing, in-process and finished product testing, utilizing
a wide range of laboratory instrumentation including spectroscopy, Gas
Chromatography (GC) and High Performance Liquid Chromatography (HPLC).
These laboratory skills are applied to analytical method development,
process validation and stability testing in compliance with current
regulations governing the industry.
Written, oral and practical examinations are
mandatory at the end of the foundation and
core modules. In the advanced module, assessment
is based on dissertation and viva-voce. In
addition, the overall grade is also based
on continuous assessments encompassing GMP
and GLP compliance, pharmaceutical documentation
skills and interim quizzes.
The Pharmaceutical Quality Assurance & Quality
Control Diploma is awarded upon successful
completion of all three modules.
Graduates of this program are qualified for a career as:
Quality Assurance
Associate
Quality Control Technician
Validation Technician
Technical Writer
Quality Assurance Auditor
Documention Reviewer
Compliance Officer
