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.

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.