|Room: Carnegie 305|
|Email: [email protected]|
|School: Schaefer School of Engineering & Science|
|Department: Mechanical Engineering|
|Program: Pharmaceutical Manufacturing Engineering|
M.B.A., Fairleigh Dickinson University
B.S., Ursinus College
Elaine Lehecka Pratt, M.B.A., is an Industry Professor in the Pharmaceutical Manufacturing and Engineering graduate program in the Mechanical Engineering department of the Schaefer School of Engineering and Science at Stevens Institute of Technology. She is also the Director of the Mechanical Engineering Undergraduate Advising Center and formerly 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, GMP TEA, APhS, SME, ISPI, Pharm Tech, and Interphex, and also serves on the faculty of the PDA Training and Research Institute.
Honors & Awards
Co-op Advisor of the Year Award, Stevens Institute of Technology, 2011
Outstanding Contribution to Performance in Practice Chemicals and Pharmaceuticals Forum Newsletter, 1998
Senior Member - ASQ [American Society for Quality]
Member - GMP Training and Education Assocation
Member - PDA [Parenteral Drug Association]
Past Member - PDA Biennial Training Conference Planning Committee
Past President - GMP Training and Education Association
Past Co-Chair - ASTD Pharmaceutical/Chemical Industry Group
Past Member - GMP TEA Biennial Training Conference Planning Committee
Past Member - PMA/PhRMA Training and Education Resource Committee
- Elaine Pratt. (Oct 2015). "Great GMP Training Ideas from the FDA Website", GMP Training and Education Association Biennial Training Conference. Orlando, FL.
- Elaine Pratt. (Oct 2012). "Training and Troubleshooting - How Current SOP Training Covers Only Half of What Trainees Need to Know", PDA Biennial Training Conference. Bethesda, MD.
- Elaine Pratt. (Oct 2011). "What Training Can Learn from FDA Consent Decrees", GMP Training and Education Association Biennial Training Conference. Orlando, FL.
- Elaine Pratt. (Oct 2011). "So You're a (New) GMP Trainer - The 10 Hats You Wear", GMP Training and Education Association Biennial Training Conference. Orlando, FL.
- 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.
- Elaine Pratt. (May 2012). "Controlling Contamination in Multi-Product Facilities", Controlled Environments, 9-11.
- 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.
- 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.
- PME 530 Introduction to Pharmaceutical Manufacturing
- PME 541 Validation of Computerized Systems
- PME 542 Global Regulation and Compliance in the Pharmaceutical Industry
- PME 560 Quality in Pharmaceutical Manufacturing
- PME 629 Manufactoring of Sterile Pharmaceuticals