MBA and M.S. in Pharmaceutical Manufacturing Dual Degree Master’s Program

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 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.

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 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.

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.

Technical tools and knowledge required to operate and manage in medical devices manufacturing environment. Current requirements in medical devices regulations, quality systems, and design elements related to manufacturing steps to assure patients health and safety. Requirements concerning selection and supply of raw materials and components for manufacturing; design and qualification of facilities, equipment, and process systems; testing, controls and inspection for compliance. Combination products, validation, external contractors, and case studies. Focus on understanding the principles and methods required in a medical devices manufacturing environment in compliance with GMP regulations.

This course introduces managers to the essence of business economics – the theories, concepts and ideas that form the economist’s tool kit encompassing both the microeconomic and macroeconomic environments. Microeconomic topics include demand and supply, elasticity, consumer choice, production, cost, profit maximization, market structure, and game theory while the Macroeconomic topics will be GDP, inflation, unemployment, aggregate demand, aggregate supply, fiscal and monetary policies. In addition the basic concepts in international trade and finance will be discussed.

This course will provide the student with the principles and techniques of financial and managerial accounting for technical organizations. The emphasis will be on the use of financial data for decision making. The basics of accounting will briefly be covered, with the major amount of time spent on ways to understand, analyze and use the data for decision making. Budgeting and analysis of performance, as well as, recognizing fixed and variable expenses are other key areas of financial management. Issues of valuation, time value of money, uncertainty and risk will be integrated in the material. The one-term course will make extensive use of the text by Weygandt et al (see below), supplemented by cases, exercises, homework and examinations. Emphasis will be on real-world, practical application of the tools of finance to management decision making.

This course provides students with a rigorous introduction to the fundamental principles of finance. The primary concepts covered include the time value of money, principles of valuation and risk. Specific applications include the valuation of debt and equity securities as well as capital budgeting analysis, financial manager’s functions, liquidity vs profitability, financial planning, capital budgeting, management of long term funds, money and capital markets, debt and equity, management of assets, cash and accounts receivable, inventory and fixed assets. Additional topics include derivative markets.

This course is intended to integrate all previously taken courses in the program by presenting a set of increasingly complex business problems. These problems can be solved through analytic skills taught in this and previous courses. In particular, the course is intended to reinforce the understanding of analysis as a way to build models that can focus attention on parts of the system that can be improved through intervention. The early part of the course uses synthetic data and empirical data readily available for analysis. The second part of the course encourages students to state and solve their own problem, gathering their own data as a part of the analytic process.

Project success depends, largely, on the human side. Success in motivating project workers, organizing and leading project teams, communication and sharing information, and conflict resolution, are just a few areas that are critical for project success. However, being primarily technical people, many project managers tend to neglect these "soft" issues, assuming they are less important or that they should be addressed by direct functional managers. The purpose of this course is to increase awareness of project managers to the critical issues of managing people and to present some of the theories and practices of leading project workers and teams.

Executives make decisions every day in the face of uncertainty. The objective of this course is to help students understand how decisions are made, why they are often less than optimal, and how decision-making can be improved. This course will contrast how managers do make decisions with how they should make decisions, by thinking about how “rational” decision makers should act, by conducting in-class exercises and examining empirical evidence of how individuals do act (often erroneously) in managerial situations. The course will include statistical tools for decision-making, as well as treatment of the psychological factors involved in making decisions.

The study of marketing principles from the conceptual, analytical, and managerial points of view. Topics include: strategic planning, market segmentation, product life-cycle, new product development, advertising and selling, pricing, distribution, governmental, and other environmental influences as these factors relate to markets and the business structure. 

This course covers the general area of management of operations, both manufacturing and non-manufacturing. The focus of the course is on productivity and total quality management. Topics include quality control and quality management, systems of inventory control, work and materials scheduling, and process management.

Project success depends, largely, on the human side. Success in motivating project workers, organizing and leading project teams, communication and sharing information, and conflict resolution, are just a few areas that are critical for project success. However, being primarily technical people, many project managers tend to neglect these "soft" issues, assuming they are less important or that they should be addressed by direct functional managers. The purpose of this course is to increase awareness of project managers to the critical issues of managing people and to present some of the theories and practices of leading project workers and teams.

An interdisciplinary course which examines the elements of, and the framework for, developing and implementing organizational strategy and policy in competitive environments. The course analyzes management problems both from a technical-economic perspective and from a behavioral perspective. Topics treated include: assessment of organizational strengths and weaknesses, threats, and opportunities; sources of competitive advantage; organizational structure and strategic planning; and leadership, organizational development, and total quality management. The case method of instruction is used extensively in this course.

Field Consulting Project Capstone Course