In regulated environments, companies are expected to establish procedures for document change control as a way of ensuring product quality and safety. Any changes made to the product, system or facility, (e.g., manufacturing, processing, quality assurance/quality control, information technology (IT), etc.) need to be documented in a timely manner. Changing existing or creating new documentation typically involves multiple disciplines and can have long lead times.Read More
Niranjan Kulkarni, PhD
Director of Operations Improvement
Kulkarni is the director of operations improvement at CRB. He holds a doctorate and master’s degree in industrial and systems engineering from Binghamton University. He is also a certified Lean Six Sigma Master Black Belt. Niranjan has over 15 years of experience in business process and data modeling, operations and process simulations, process improvements, layout optimizations and supply chain management. He has worked with the pharmaceutical, biotech, food, chemical, semiconductor, electronics assembly and packaging, manufacturing and financial industries.
Kulkarni is a frequent speaker at industry events, such as the International Society of Pharmaceutical Engineers, INTERPHEX and Tradeline. He is also an active speaker and contributor to academic research societies, including the Institute of Electrical and Electronics Engineers, Institute of Industrial & Systems Engineers (IISE) and the Institute for Operations Research and the Management Sciences. He is the co-chair of ISPE’s Operations Management Community of Practice and a regional vice president of IISE’s South Central Region.
Kulkarni has authored over 25 peer reviewed papers published in research journals, conference proceedings and industry periodicals. He is the co-author of the ISPE’s Good Practice Guide on operations management (published in 2016) and has also co-authored a book chapter in the prestigious Lecture Notes in Computer Science series. Kulkarni is also on the editorial review board of the International Marketing and Management Research.