James Vesper designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries. Beginning in March 2017, he became Director, ValSource Learning Solutions after establishing and being president of the firm, LearningPlus, Inc. At ValSource, he is leading a business unit that provides innovative learning solutions to pharma firms world-wide, leveraging the capabilities and expertise of ValSource consultants.
He has had more than 35 years’ experience in the pharmaceutical industry. Dr. Vesper worked eleven years at Eli Lilly and Company, Indianapolis, Indiana. His first assignment was as corporate industrial hygienist, followed by three years in Corporate Quality Assurance. There, he was responsible for issues concerning the manufacture and testing of parenteral products made at Lilly facilities and third parties worldwide. His last assignment at Lilly was as Project Leader of GMP (Good Manufacturing Practice) Education and Instruction, establishing the department and its mission. Dr. Vesper is frequently asked to speak at conferences and technical meetings and present training courses and workshops on GMPs, Contamination Control, Quality Risk Management, Investigation Report Writing, and Learning & Performance solutions.
Dr. Vesper teaches for the PDA Training and Research Institute, is on the PDA Q9 (R2) commenting team and is heading the Training and Learning Effectiveness working group for the Society of Sterility Assurance Professionals. He is an invited speaker for the PDA Annual Meeting in April 2022 and the Association for GXP Excellence in May 2022.
Dr. Vesper has written six books, including Root Cause Investigations for CAPA (2020) and multiple technical articles. His 5th Edition of GMP in Practice, written with Tim Sandle was published in 2016 by PDA/DHI. He has received the PDA’s Agallico Award for Teaching Excellence and, in 2021, PDA’s Distinguished Author/Editor of the Year. He has also served as a consultant to World Health Organization’s (WHO) Vaccine Quality Network – Global Learning Opportunities and has been a mentor on six of the WHO’s unique learning program, Pharmaceutical Cold Chain Management on Wheels. He has trained health authority inspectors through WHO and PIC/S in US, Taiwan, London, China, Greece, and Turkey.
Dr. Vesper divides his time between Provincetown, Massachusetts and Rochester, New York. He has a BS in biology (Wheaton College) an MPH (University of Michigan School of Public Health), and a Ph.D. in Education from Murdoch University in Perth, Western Australia.