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 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.
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.
MGT 684:Regulation and Compliance in the Pharmaceutical Industry
This course explores the U.S. and international regulatory environments that govern the pharmaceutical and biotechnology industries with particular focus on the U.S. 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. Where appropriate, case studies will be used to illustrate the challenges and issues associated with compliance, as well as the consequences of non-compliance. 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.
Schaefer School of Engineering & Science
Department:
Mechanical Engineering
Program:
Pharmaceutical Manufacturing Engineering
Research & Education
Education
M.B.A. in Management, Fairleigh Dickinson University
B.S. in Biology, Ursinus College
Experience & Service
Experience
Elaine Lehecka Pratt, M.B.A., is an Industry Professor in the Pharmaceutical Manufacturing graduate program in the Mechanical Engineering department of the Schaefer School of Engineering and Science at Stevens Institute of Technology. She has also served as the Interim Program Director for the Pharmaceutical Management graduate program in the Howe School of Technology Management at Stevens Institute. She has 10 years of pharmaceutical industry experience, having worked in tablet production line supervision and as Technical Training Manager for Schering-Plough Corporation. For over 20 years, she has maintained an active consultancy to the pharmaceutical industry, specializing in regulatory compliance, GMP and technical training, documentation, and quality assurance consulting. Recognized as an industry expert in the field of regulatory compliance training, she has spoken at national and international conferences of ASQ, ASTD, PDA, PMA, CMP TEA, APhS, SME, ISPI, Pharm Tech, and Interphex, and also serves on the faculty of the PDA Training and Research Institute.
Achievements & Professional Societies
Professional Societies
Senior Member - ASQ [American Society for Quality] Member - ASTD [American Society for Training and Development] Member - GMP Training and Education Assocation Member - PDA [Parenteral Drug Association]
Member - PDA Biennial Training Conference Planning Committee Former President - GMP Training and Education Association Former Co-Chair - ASTD Pharmaceutical/Chemical Industry Group Former Member - GMP TEA Biennial Training Conference Planning Committee Former Member - PME Training and Education Resource Committee
Honors & Awards
Outstanding Contribution to Performance in Practice Chemicals and Pharmaceuticals Forum Newsletter, 1998
Selected Publications
Conference Proceedings
Elaine Pratt. (Oct 2010). "Risk Analysis: How to Teach It and How to Use It for Training", PDA Biennial Training Conference, Baltimore, MD.
Elaine Pratt. (Nov 2009). "Risk Analysis: What, How and Why", GMP Training and Education Association Biennial Training Conference, Orlando, FL.
Elaine Pratt. (Apr 2008). "Strategies for a Successful FDA/ISO Audit", American Society for Quality Conference, East Hanover, NJ.
Elaine Pratt. (May 2004). "Recent Compliance Trends and Changes", PDA Conference, San Juan, Puerto Rico.
Elaine Pratt. (Apr 2004). "How to Be Audit-Ready 24/7", American Society for Quality Conference, East Hanover, NJ.
Book Chapters
Elaine Pratt. (2010). "Virtual Teams in Very Small Classes", Virtual Teams: Mastering the Art and Practice of Online Learning and Corporate Collaboration, Robert Ubell, John Wiley and Sons.
Journals
Elaine Pratt. (1999). "Combining GMP and ISO 9000 Training", Performance in Practice, 5.
Elaine Pratt. (1999). "Sound Bite Training", Performance in Practice, 5-6.
Elaine Pratt. (1998). "The Pros and Cons of Employee Certification Programs", Performance in Practice, 10-11.
Elaine Pratt. (1998). "Creative Ways to Stretch Your Training Resources", Performance in Practice, 8-9.
Elain Pratt. (1989). "Designing and Implementing an International GMP Training Program", Pharmaceutical Technology, Reprinted in Pharm Tech Japan. (13), 50-60.
Elaine Pratt. (1985). "Pharmaceutical Professionalism - Bridging the Gap to High Tech", Drug Development and Industrial Pharmacy, 1617-1620.
