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The Pharmaceutical Quality Control program is a hands-on pharmaceutical analysts program that combines applied chemistry with specific in-depth training in pharmaceutical industry drug analysis. Practical experience in quality control is imparted through skills gained in areas such as raw material testing, in-process testing, finished product testing, method validation and pharmaceutical statistics. Some of the skills acquired during the program include:
The foundation module is designed to provide a background in applications of analytical chemistry and introduce new concepts in pharmaceutical quality control, statistics, pharmaceutical laboratory compliance and GMP. A crucial component of the foundation module is the introduction of pharmaceutical laboratory safety and chemical handling which prepares students for dealing with pharmaceutical laboratory compliance issues.
This module provides training in pharmaceutical instrumentation and quality control drug testing. Emphasis is placed on:
- Compendial drug assays
- In-process quality control testing
- Analytical Instrumentation
- Laboratory GMP compliance
- Sampling plans & Statistics
Method validation Practical training is provided in analytical instruments such as HPLC , which includes the method validation and standard operating procedures.
The advanced module is primarily project based. These projects include compendial drug assays, in-process and finished product testing, utilizing primarily UV-VIS Spectroscopy and High Performance Liquid Chromatography (HPLC). These laboratory skills are applied to analytical method validation and drug testing in compliance with current regulations governing the industry.
Examination & Continuous Assessment
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 Control Analyst Certificate is awarded upon successful completion of all three modules.
Graduates of this program are qualified for a career as:
- Quality Control Analyst-Level I
- Quality Control Technician
- Laboratory Chemist
- In-Process QC
- Validation Technician