The pharmaceutical and medicine manufacturing industry develops and produces a variety of medicinal and other health-related products that save the lives of millions of people from various diseases and permits many people suffering from illness to recover to lead productive lives. This industry is dependent on discovering and developing medicines, manufacturing these products commercially and marketing them to health officials or consumers. Industry players adopt unique strategies to overcome the many challenges they face in addressing the prevalent health issues of our times. The Pharmaceutical Certificate Program provides a solid foundation for professionals by providing a comprehensive overview of the pharmaceutical industry, manufacturing operations, facilities development, and drug discovery process. In addition, the program will cover in depth the various pharmaceutical validation processes, good manufacturing practice (GMP), regulatory agencies, and the quality function.
This Pharmaceutical Fundamentals Certificate is primarily suited for professionals who intend to learn/expand their technical pharmaceutical manufacturing, business, quality, or regulatory skills, and apply them to advance in their profession and within their companies.
The Pharmaceutical Fundamentals Certificate Program is composed of the following four courses:
Pharmaceutical Manufacturing: An Introduction
This course provides an overview of the pharmaceutical industry, including basic information about drug discovery and development, FDA requirements and approval processes, drug dosage forms, and the role of key operational units in drug manufacturing processes. This course enables the students to: understand the role of the pharmaceutical industry in the global market and its implications; learn the fundamentals of the drug development cycle and the investment required to bring a drug to market; learn the most important drug manufacturing processes and the key elements of dosage formulation.
Pharmaceutical Validation Processes
This course provides a basic understanding of the validation process as required by the Food and Drug Administration of the United States for drugs manufactured in the United States and all imported drugs. This course also reviews applicable definitions and descriptions of the process and documents required in the validation of a facility. The process of validation is explained along with the intent of the validation effort. Relationships between types of protocols and other documents which occur at the same time during the construction and startup of a pharmaceutical facility are explored. The final results of the validation process are described and how the effort is prepared for an FDA inspection is touched on.
Pharmaceutical Quality Assurance & Regulatory Affairs
Quality control measures are mandated both by the development company and by regulatory agencies to ensure product identity, purity and safety. This course presents the regulations set forth by regulatory agencies with emphasis on the FDA model. We also introduce Good Manufacturing Practice criteria and reviews Quality Assurance and Quality Control functional responsibilities.
Pharmaceutical Discovery Process
Pharmaceutical – Drug Discovery Process is a course that surveys how new drugs are discovered and brought to the clinic. This course provides a detailed picture of the complex and highly interrelated activities of the development cycle for drugs and biologics, from discovery to a successful commercialization.
After completion of the Pharmaceutical Fundamentals Certificate Program, students will be equipped with a basic understanding of the following:
- Pharmaceutical industry overview
- Pharmaceutical manufacture and operations processes
- Validation processes
- Good manufacturing practices (GMP)
- Regulatory agencies
- Regulatory compliance
- Quality function
- Drug discovery process
- Commercialization process
- Intellectual property rights
- Outlook for the future
No prior experience or coursework required.
Students will be assigned 5 homework assignments, and 1 final exam.
See the syllabus of the four(4) courses for details
This course is Instructor-led and delivered through our award-winning online Learning Management System.