Online Pharmaceutical Manufacturing Master's

Pharmaceutical manufacturing is a vital part of technical operations in any pharmaceutical company.  This course introduces students to manufacturing various drug products while considering regulatory compliance requirements regarding safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company.

Become familiar with current Good Manufacturing Practice (GMP) compliance in the design of pharmaceutical and biopharmaceutical facilities. Uncover issues related to process, material, and people flow. Learn about the special needs of the pharmaceutical industry for architecture and engineering, including mechanical, industrial, electrical and computer systems. Study specialized requirements for HVAC, automation, and bio-safety. Develop effective written procedures to document highly complex yet safe processes. Find out how to defend products against contamination.

Validation of a pharmaceutical manufacturing process is an essential requirement with respect to compliance with Good Manufacturing Practices (GMP). Course covers: validation concepts for process, equipment, facility, cleaning, sterilization, filtration, analytical methods and computer systems; validation Master Plans, IQ, OQ, and PPQ protocols; and validation for medical devices.

This course is focused on the application of statistics and statistical reasoning in pharmaceutical manufacturing, particularly in production, quality assurance, quality control, validation and analytical laboratories. Basic statistical definitions and concepts are described. Students will learn various measures of central tendency and spread of data, how to present data graphically and be introduced to the probability distributions most commonly encountered in pharmaceutical manufacturing. Approaches to choosing samples for analysis, statistical inference, sample size and power will be discussed. The course also covers regression and correlation, analysis of variance, gage repeatability and reproducibility, statistical process control, process capability analysis and design of experiments as applied to pharmaceutical manufacturing. Students will learn to apply statistical software to analyze common problems that arise in pharmaceutical manufacturing operations, including evaluation of dosage form weight and content uniformity, potency, dissolution, bio-equivalency and other product quality attributes.

This course provides a detailed exploration of quality programs with specific application to the particular requirements of the life sciences industry. Students will develop an understanding of the quality philosophy which drives the industry from discovery through manufacturing, and of the systems and tools that are employed to implement and maintain a sustainable and successful quality system. Application of quality strategies in research and development, commercial production, computer systems, post-marketing, and other areas will be included. Where appropriate, case studies will be used to illustrate the challenges and issues associated with quality system deployment.

The course covers oral solid dosage (OSD) manufacturing and packaging in the pharmaceutical industry. Production unit operations include blending, granulation, size reduction, drying, compressing, and coating for tablets, as well as capsule production and filling. Packaging aspects reviewed include requirements for primary and secondary containers and labeling, package testing. The course emphasizes design, scale-up, trouble-shooting, validation, quality testing, and operation of typical OSD manufacturing and packaging facilities, including equipment, material flow, utilities, and quality assurance. The term project required for this course involves conceptual design of a contract manufacturing and packaging facility for OSD products.

This course is focused on the special characteristics and types of sterile dosage forms and the technologies for their manufacturing. Topics such as environmental and contamination controls, facility design, water and air quality, personnel and other requirements for sterile manufacturing are covered. Sterilization methods for the equipment, components, intermediate and finished products are reviewed. Terminal sterilization and aseptic processing technologies including blow- fill-seal and barrier isolation systems are discussed. The course also includes topics such as Good Manufacturing Practices (GMP) regulations and guidance on aseptic manufacturing, quality assurance and control, stability, storage and distribution applicable to sterile dosage forms manufacturing.

Computers and computerized systems are ubiquitous in pharmaceutical manufacturing. Validation of these systems is essential to assure public safety and compliance with appropriate regulatory issues regarding validation: GMP, GCP, 21CFR Part 11, etc. This course covers validation concepts for various classes of computerized systems and applications used in the pharmaceutical industry; importance of requirements engineering in validation; test protocols and design; organizational maturity considerations.

This course explores the economic theory of regulation in general, and the US and international regulatory environments that govern the pharmaceutical and biotechnology industries with particular focus on the US Food and Drug Administration, the European Agency for the Evaluation of Medical Products and the Japanese Ministry of Health, Labor and Welfare. The essential components of Good Laboratory Practices, Good Clinical Practices, and Good Manufacturing Practices regulations will be covered. Students will develop an understanding of the formulation and execution of regulatory strategy and key ethical issues in medical research and production. Where appropriate, case studies will be used to illustrate the challenges and issues associated with compliance as well as the consequences of noncompliance. Ethical issues and the potential consequences of ethical lapses will also be explored. Current events will be used to illustrate key ethical principles and serve as a basis for discussion.

This course is focused on topics related to the technology, design and operations of modern biopharmaceutical facilities. It covers process, utilities and facility design issues and encompasses all major manufacturing areas, such as fermentation, harvest, primary and final purification, media and buffer preparation, equipment cleaning and sterilization, critical process utilities, unit operations including cell culture, centrifugation, conventional and tangential flow filtration, chromatography, solution preparation, and bulk filling. The application of current Good Manufacturing Practices and Bioprocessing Equipment Standards will be discussed.