Pharmaceutical Manufacturing

Students will learn the techniques for developing and implementing a training policy that best satisfies the various levels of responsibility in pharmaceutical manufacturing as well as the good manufacturing practices and standard operating procedures. 

A study of the FDA regulations as it relates to the quality of drug products in the monitoring of compliance with Current Good Manufacturing Practice regulations to ensure safe use, ingredients, and strength.

An introduction to the sterile procedures associated with pharmaceutical manufacturing.

This course will focus on the elements of sterilization in pharmaceutical manufacturing. Topics include managing microorganisms, upstream contamination, redundancy, utility prefiltration, compressed air drying, and process line filtration.

This course will focus on the FDA guidelines to ensure the quality of drug products by carefully monitoring drug manufacturers' compliance with Current Good Manufacturing Practice (CGMP) regulations. 

This course will provide an overview of the Pre-approval inspection requirements to acquire commercial manufacturing license for a new drug.

The focus of this course will provide a background for understanding the ideas and concepts associated with pharmaceutical compounding and manufacturing.

A study of the use, procedures, and effectiveness of predictive modeling in a pharmaceutical unit.

A study of the concepts required for continuous improvement within a pharmaceutical manufacturing industry. These processes include the spectrum of drug development, manufacturing, and distribution.

This course is the culmination of the Pharmacy Manufacturing program. The successful capstone project is vested in a research effort that demonstrates a thorough knowledge of a tactic within the focus area. The intent is documented expansion of the body of knowledge within pharmacy manufacturing.