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Pharmaceutical Quality Control
and Quality Assurance Diploma
The Diploma in Pharmaceutical Quality Control and Quality
Assurance (Dip.QCQA) provides students with the comprehensive
knowledge and skills in the fields of Pharmaceutical
Analysis, Quality Assurance and Regulatory Affairs.
The courses are delivered by experts from both pharmaceutical
and biopharmaceutical industries, using state-of-the-art
technologies, to provide the students with strong technical
and practical skills needed in a US-FDA and Canadian
TPD regulated work environment.
The Diploma Program is delivered in three phases over
a period of 12 months. Highlights of the courses delivered
during the different phases are given below:
Careers - Scientist
/ Analyst Careers
Chemists test drug materials for quality,
purity and strength, using approved methodology and
safety practices. They produce sample batches of a drug
for trouble-shooting and help design the scaling-up
process that takes drug manufacture up to factory proportions.
Advanced positions require extensive record keeping
and the supervision and integration of a lab team.
Desired qualification for entry to the quality jobs:
- Excellent knowledge of laboratory
equipment (such as HPLC, Dissolution, FTIR, UV, etc)
- Excellent analytical and laboratory
skill Knowledge
- Familiarity with industry regulations
such as GMP and GLP
- Excellent organizational, interpersonal,
and communication skills
- Demonstrated time management skills
and the ability to work toward deadline
- University Degree
Quality Careers
A wide range of quality assurance/quality
control positions exist in government, industry and
research. Positions include QC supervisors and technicians
utilizing chemistry and microbiology, validation managers,
QA documentation specialists, QA Associates, QA auditors,
and senior management positions in QA/QC regulatory
affairs.
Desired qualification for entry to the quality jobs:
- Knowledge of GLP, GCP, GMPs
- Excellent organizational, interpersonal,
and communication skills.
- Ability ot assess and identify
GMP and quality-related issues in details
- Demonstrated time management skills
and the ability to work toward deadlines
- Understanding of various regulatory
(Health Canada, FDA, European) requirements
- University Degree
| Post-Graduate Diploma
in Pharmaceutical Quality Assurance & Quality
Control Program |
| |
|
| Introduction
to Good Manufacturing Practices – Level I |
| Introduction
to Pharmaceutical Laboratory Testing – Level
I |
| Workplace
Hazardous Material Information Systems (WHMIS) |
| Introduction
to Pharmaceutical Dissolution Testing – Level
I |
| Introduction
to High Performance Liquid Chromatography –
Level I |
| Introduction
to Pharmaceutical Manufacturing Methods |
| Good
Manufacturing Practices – Level II |
| Pharmaceutical
Laboratory Testing – Level II |
| Pharmaceutical
Dissolution Testing – Level II |
| High
Performance Liquid Chromatography – Level
II |
| Introduction
to Pharmaceutical, Biological/Biotechnology, Natural
Health Products and Medicines |
| Introduction
to International Food and Drug Laws, Regulations
and Guidelines |
| Technical
Writing and Scientific Communication |
| Good
Manufacturing Practices – Level III |
| Pharmaceutical
Laboratory Testing – Level III |
| High
Performance Liquid Chromatography – Level
III |
| Regulatory
Submission |
| Global
Regulatory Strategies |
| Introduction
to Auditing – level I |
| Advanced
Auditing – Level II |
| Preclinical
–Drug |
| Clinical
- Drug |
| Cleaning
Validation |
| Pharmaceutical
Stability Program |
| Advance
High Performance Liquid Chromatography – Level
IV |
| Introduction
to Clinical Trials |
| Chemistry
Manufacturing and Control |
| Post
Approval Activities and Compliance |
| Formularies
and Reimbursement |
| Natural
Health Products |
| Biologics/Biotechnology
Products |
| Medical
Devices |
| Labeling
and Product Summaries |
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