• PME 530 Introduction to Pharmaceutical Manufacturing

  Pharmaceutical manufacturing is vital to the success of the technical operations of a pharmaceutical company. This course is approached from the need to balance company economic considerations with the regulatory compliance requirements of safety, effectiveness, identity, strength, quality, and purity of the products manufactured for distribution and sale by the company. Overview of chemical and biotech process technology and equipment; dosage forms and finishing systems; facility engineering; health, safety, and environment concepts; and regulatory issues.

• PME 531 Process Safety Management

  This course reviews the 12 elements of the Process Safety Management (PSM) model created by the Center for Chemical Process Safety of the American Institute of Chemical Engineers. PSM systems were developed as an expectation/demand of the public, customers, in-plant personnel, stockholders, and regulatory agencies because reliance on chemical process technologies were not enough to control, reduce, and prevent hazardous materials incidents. PSM systems are comprehensive sets of policies, procedures, and practices designed to ensure that barriers to major incidents are in place, in use, and effective. The objectives of this course are to: define PSM and why it is important, describe each of the 12 elements and their applicability, identify process safety responsibilities, give real examples and practical applications to help better understand each element, share experiences and lessons learned of all participants, and assess the quality and identify enhancements to a student’s site PSM program.

• PME 535 Good Manufacturing Practice in Pharmaceutical Facilities Design

  Current Good Manufacturing Practice compliance issues in design of pharmaceutical and biopharmaceutical facilities; issues related to process flow, material flow and people flow, and A&E mechanical, industrial, HVAC, automation, electrical, and computer; bio-safety levels; developing effective written procedures so that proper documentation can be provided, and then documenting through validation that processes with a high degree of assurance do what they are intended to do; levels I, II, and III policies; clinical phases I, II, and III, and their effect on plant design; defending products against contamination; and building quality into products.

• PME 537 Sustainable Design and Operation for FDA Regulated Facilities

  Course addresses the sustainable operation and design of facilities and sites subject to regulatory requirements of US federal agencies such as FDA, NIH, OSHA, EPA, DOE and/or applicable international regulators.  Course presents timely issues, challenges and potential benefits of implementing sustainable means and methods to meet new Green Codes and Design Standards that are either in draft review or final version for the regulated facility, whether in planning, design, construction or operation phase. Regulated buildings typically  have their own unique requirements in their operation,  which require special knowledge to comply and or mitigate safety and regulatory issues, while minimizing impact of rising energy costs to manufacturers, saving scarce resources,  and protecting the environment. Furthermore, course introduces the students to resources, survey information of latest sustainable/Green thinking in Green Chemistry, Sustainability  and Energy Efficient Design and Products to reduce waste, energy consumption, eliminate unnecessary or optimize manufacturing steps, cut operating costs and be environmentally sensitive. 
  Topics include: Global trends in Green Regulations and Design Standards, history of “Sustainable Design,” examples of sustainability in large companies, site selection issues,  water resource conservation, architectural issues and material selections, energy resource conservation and efficiency design for mechanical, electrical, and plumbing (MEP) systems in regulated  facilities, energy performance of buildings, waste and environmental issues, material resource conservation and efficiency (disposables, packaging), construction techniques toward a sustainable certified facility,  sustainable design for cGMP facilities and labs, building operations and maintenance. Course will provide useful, current and practical knowledge of Green and Sustainability Design and operation to individuals who are in or entering a technical career in regulated industries such as pharmaceutical, medical devices, and other sectors that have energy-intensive and regulated facilities.

• PME 538 Chemical Technology Processes in API Manufacturing

  Bulk active pharmaceutical ingredient manufacturing and unit operations; process scale-up; transport processes, including mass, heat, and momentum transfer; process synthesis, analysis, and design; traditional separation processes, including distillation, evaporation, extraction, crystallization, and absorption; new separation processes, including pressure swing adsorption, molecular sieves, ion exchange, reverse osmosis, microfiltration, nanofiltration, ultrafiltration, diafiltration, gas permeation, pervaporation, supercritical fluid extraction, and high performance liquid chromatography (HPLC); and batch and continuous reactors for homogeneous, heterogeneous, catalytic, and non-catalytic reactions.

• PME 539 Bioprocess Technology in API Manufacturing

  This course provides a broad overview of topics related to the 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, and critical process utilities. Unit operations include cell culture, centrifugation, conventional and tangential flow filtration, chromatography, solution preparation, and bulk filling. Application of current Good Manufacturing Practices and Bioprocessing Equipment Standards (BPE-2002) will be discussed.

• PME 540 Validation and Regulatory Affairs in Pharmaceutical Manufacturing

  An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).

• PME 541 Validation of Computerized Systems

  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.

• PME 542 Regulation and Compliance in the Pharmaceutical Industry

  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.

• PME 551 Process Analytical Technology (PAT) in Pharmaceutical Operations

  This course provides an overview of PAT applications in pharmaceutical operations.  At the conclusion of the course, students will understand the PAT life cycle, be able to identify PAT applications likely to yield positive benefit, understand issues of organizing and managing a PAT project and integrating the principles of Quality by Design into the effort (i.e. design control, facility and equipment control, production and process control, and material control).  Students will also understand the principles of integrating PAT application projects with the six-sigma approach to process improvement:  Define, Measure, Analyze, Improve and Control (DMAIC). Topics covered include:  PAT applications, risk analysis/risk management, project management issues (integrating PAT into process and product development, technology transfer to manufacturing, change management, etc.), and the PAT system project life cycle.  Examples of PAT impact on workflow, productivity, process variability and product quality will be discussed.

• PME 560 Quality in Pharmaceutical Manufacturing

  This course provides a detailed exploration of quality programs with specific application to the particular requirements of the pharmaceutical 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.

• PME 570 Biopharmaceuticals - Product Development and Upstream Production Systems

  Course covers the following topics: Structure and physical, chemical and biological attributes of biologics.  Product stability, pharmacokinetics, delivery.  Critical quality attributes of Pioneer Drugs and Biogenerics.  Fundamentals of nucleic acid and protein structure and function.  Genetic engineering tools.  Modern production vectors and hosts.  Cell line and media selection and optimization.  Cell-bank characterization and stability.  Upstream processes.  Culture, fermentation and scale-up.  Critical upstream process parameters, regulatory controls and validation.  Rapid vaccine manufacturing and monoclonal antibody case studies.  Prerequisites: Students must have taken at least one course in organic chemistry and one course in biochemistry, molecular biology, or genetics, or equivalent background as determined by instructor.

• PME 580 Medical Device Design and Technology

  Early history of medical devices and procedures.  Minimally invasive and open procedures, techniques and devices, including mechanical and electrosurgical devices.  Manufacturing methods for catheters, balloons, plastic and metal components.  Design of metal device components including material selection and strength and deformation adequacy using material properties and classical mechanics.  Selection of insulation materials for and testing of electrosurgical devices.  Selection of medical plastics and design elements.  Balloon and catheter burst strength.  The Poiseuille flow equation and its use for fluid flow through catheters and vessels.  Rapid prototyping techniques, advantages and limitations.  Understanding of biocompatibility testing and accelerated age testing using the Arrhenius equation.  Device sterilization methods and testing.  Developing a project plan from brainstorming to product release for a new device.                                                     

• PME 590 Risk-Based Compliance in the Pharmaceutical Industry

  Course presents Quality Risk Management, including Risk-Based Compliance for Cross Contamination, Occupational Safety, and Environmental Protection. Addresses the issues of occupational exposure to high hazard pharmaceutical compounds, and product-to-product cross contamination in multipurpose facilities. Explores issues that a pharmaceutical professional needs to understand regarding projects that put the workforce or product at risk and, in the case of product exposure, impact product quality and regulatory scrutiny. Included are emission sources and essentials, routes of exposure, toxicology, safety and regulatory limits of exposure, exposure control for facilities and processes, quantitative risk assessment, and mitigation techniques.

• PME 600 Engineering Economics and Cost Analysis

  This course presents advanced techniques and analysis designed to permit managers to estimate and use cost information in decision making. Topics include: historical overview of the management accounting process, statistical cost estimation, cost allocation, and uses of cost information in evaluating decisions about pricing, quality, manufacturing processes (e.g., JIT, CIM), investments in new technologies, investment centers, the selection process for capital investments, both tangible and intangible, and how this process is structured and constrained by the time value of money, the source of funds, market demand, and competitive position.

• PME 609 Introduction to Project Management

   This course deals with the problems of managing a project, which is defined as  a temporary organization of human and non-human resources, within a permanent  organization, for the purpose of achieving a specific objective; both  operational and conceptual issues will be considered. Operational issues  include definition, planning, implementation, control and evaluation of the  project.  Conceptual issues include project management vs. hierarchical  management, matrix organization, project authority, motivation and morale.  Cases will be used to illustrate problems in project management and how to  resolve them.

• PME 621 Pharmaceutical Mixing

  Fundamentals of mixing relevant to pharmaceutical engineering, flow patterns, dead zones, components of mixers, importance of baffling, determination of flow, power, and shear rates, effect of rheology, “shaken, not stirred”, why viscosity affects more than just Reynolds numbers, continuous processing, heat transfer, suspending solids that sink or float, wetting out solids, concepts of crystallization, catalysis, mass transfer, liquid-liquid dispersions, emulsions, and separations, fermenters, hydrogenators, other gas-liquid applications, pit-falls of scale-up, why scale-down is the better way to design, process intensification and solids-solids mixing.

• PME 628 Manufacturing and Packaging of Pharmaceutical Oral Solid Dosage Products

  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 filling. Packaging aspects reviewed include requirements for primary and secondary containers and labeling, package testing. The course emphasizes design, scale-up, trouble-shooting, validation, and operation of typical OSD manufacturing and packaging facilities, including equipment, material flow, utilities, and quality assurance. Topics related to cGMP, process validation, manufacturing and packaging documentation, QA and QC in OSD manufacturing will be presented. The term project required for this course involves conceptual design of a contract manufacturing and packaging facility for OSD products, including equipment selection, development of the process flow diagrams, room layouts and other design elements, as well as preparation of Standard Operating Procedures for various unit operations.

• PME 639 Modeling and Simulation of Pharmaceutical Manufacturing Systems

  This course will introduce students to modeling and simulation applications in pharmaceutical manufacturing. The fundamentals of discrete event simulation and the use of commercially available software to develop models of various manufacturing and service systems will be introduced. Approaches to the development of conceptual and computer models, data collection and analysis, model verification and validation, and simulation output analysis will be discussed. The modeling of chemical, biochemical and separation processes in pharmaceutical manufacturing using process simulation software will be presented. Material balances, stream reports, operations and equipment Gantt charts will be developed and process debottlenecking and cost analysis will be conducted.

• PME 640 Contemporary Concepts in Pharmaceutical Validation

  Current and evolving validation concepts and standards in pharmaceutical  manufacturing, including FDAs GMPs for 21st Century, Risk Assessments  (Risk-MaPP, ICH Q7a-Q10, FMEA) and statistics in validation, Commissioning and  Qualification (ISPE and ASTM), Computer Systems Validation, Cleaning  Validation, Spreadsheet Validation, Lean Manufacturing and Six Sigma, PAT  initiative, Equipment Qualification vs.  CSV (GAMP and AAPS guidelines).  Preparation of draft validation documentation, including master plans,  protocols, test procedures and reports.  Focus is on concepts and principles  required to implement these new qualification and validation approaches in a  pharmaceutical manufacturing environment in compliance with FDA and  international regulations.  Needs knowledge of basic statistics concepts.

• PME 643 Design and Management of Aseptic

  This course presents a systematic methodology for the project management of aseptic pharmaceutical manufacturing processes. This includes the associated equipment and the integration of the preliminary design, detailed design, construction, and validation phases of a project to minimize the challenges, and cost and schedule overruns typically associated with implementing these complex processes. The content includes selection of the project team, defining the process requirements the equipment is required to meet, preparation of the equipment user requirements specifications, preparation of the equipment layout, preparation of the equipment budget, preparation of the project schedule, managing the construction of the equipment, managing the testing of the equipment, and installation of the equipment and site acceptance testing. Also addressed will be selection of and dealing with equipment vendors, planning for validation success, and regulatory acceptance.An aseptic manufacturing process case study is used as a basis for the lecture series. The process will be followed from the preparation of the raw data used to determine the process requirements through to final installation and acceptance of the aseptic processing equipment on site.

• PME 646 Biopharmaceuticals Facilities Design

  Proven techniques and creative tools presented for design, development, and delivery of biopharmaceutical manufacturing facilities.  Includes skills and knowledge in bioprocessing requirements, equipment and facility requirements, project management as well as regulatory guidelines and “big-picture” drug development. Also corporate capital management processes to functionally meet corporate requirements from pre-clinical to commercial scale of operations, qualifications to pass regulatory inspections, achieving faster “time-to-market,” but not breaking the corporate treasury bank.  Course also explores trends in new equipment technology such as disposables or single-use product, new design concepts in aseptic manufacturing, barrier and isolation technologies, new FDA thinking in risk-based compliance approach, process analytical technology, capital project planning and management.
  
  This course is primarily for engineers in the Master of Engineering program.

• PME 649 Design of Water, Steam and CIP Utility Systems for Pharma Manufacturing

  Water & steam systems: (water used as excipient, cleaning agent, or product diluent) water quality selection criteria; generation, storage, and distribution systems; bio-burden control; USP PWS (purified water systems) and USP WFI (water for injection) systems; engineering considerations, including specification, design, installation, validation, operation, testing, and maintenance; common unit operations, including deionization, reverse osmosis, distillation, ultrafiltration, and ozonation systems; process considerations, including pretreatment, storage and distribution, materials of construction, microbial control, pyrogen control, and system maintenance; FDA requirements; clean-in-place systems; and steam generation and distribution systems.

• PME 653 Design of PAT Systems for Pharmaceutical Manufacturing

  The objective of this course is to provide the student with the engineering tools and knowledge required to design and deploy Process Analytical Technology (PAT) solutions in pharmaceutical drug substance and drug product manufacturing.   This course provides in-depth coverage of current PAT technologies.  At the conclusion of this course, students will understand the engineering theory, principles, and mathematics required to design and deploy these technologies in a pharmaceutical manufacturing environment in compliance with FDA and international regulations.
  
  Topics covered include: analyzer types and principals of operation, chemometric techniques for multivariate analysis, multivariate process models, dynamic process control, and advanced pattern recognition techniques.  In addition, the course will cover the technical aspects of real-time data management and 21 CFR Part 11 compliance.This course is primarily for engineers in the Master of Engineering program.

• PME 660 Medical Devices 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.

Contacts

Dr. Richard Berkof
Program Director
201.216.5538
rberkof@stevens.edu