Chemistry Manufacturing and Control is a phrase generally used in the pharmaceutical industry when compiling quality data for New Drug submissions, clinical Trial Applications and Investigational New drug applications among others.

Quite often Chemistry Manufacturing and Controls is abbreviated as CMC. CMC is a broad field which touches on biologics and pharmaceuticals. All regulatory authorities will require information differing in detail about CMC.

This course will provide you with in-depth knowledge of Chemistry Manufacturing  and controls. It includes Drug substance, drug product stability, manufacture, packaging, container closure, controls, compatibility studies and production documents. he course assumes the learner has basic knowledge of science as required in the pharmaceutical industry. Its also assumed that the learner has no previous experience.

General information

There are very few similar online courses. This course is an in-depth online course. It was  designed for those people who  are interested in learning the Canadian CMC to help them in their career . They include

• pharmaceutical regulatory affairs,
• quality control,
• quality assurance,
• research and development and
• technical writers

Learning Levell: Basic and intermediate
Total Length of Course: 38 hours
Cost: CAD$985.

Chemistry Manufacturing and Controls

This course is for you if you will be involved in any activity that relates to the quality of a drug.  To succeed  you should have good communications skills in the English language.  As well, good understanding of chemistry and is highly  recommended. A background in drug submissions would be an advantage.

This Chemistry, Manufacturing and Controls course consists of the following topics:
-Introduction
-Drug substance
-Developing raw material specifications
-Dosage forms and routes of drug administration
-Excipients
-Packaging materials
-Compatibility studies
-Dissolution studies
-Process validation
-Stability studies
-Applications for Clinical Trials
-Post approval changes
-Drug master files

Pharmaceutical Good manufacturing practices

After completion of this course you will be able to:

Discuss the importance of Chemistry manufacturing and Controls
Describe how the quality of a drug substance and drug Product is achieved
Understand the Biopharmaceutics Classification System
Understand how the quality of excipients is maintained
Describe compatibility testing process
Discuss identification of process intermediates and impurities in a drug product and drug substance
Comprehend excipient and drug analytical methods
Describe pharmaceutical drug development
Recognize and describe master production documents

Chemistry Manufacturing and Controls

This course is Instructor-led and is delivered through our secure student friendly online Learning Management System.

Chemistry Manufacturing and Controls. There are 12 topics.  Students are required to complete all quizzes and homework assignments.  There will be  two tests.  One of these tests will be the final course examination. All tests and quizzes will consists of online multiple choice questions.

Click here for a sample quiz