Modern initiatives and technologies certainly enable the mission of the industry. But is there substantial opportunity to improve outcomes from an older paradigm with little capital investment? The answer is yes, but it will require a mindset change by both industry and regulators. The opportunity lies in the widespread adoption of true lean thinking; any activity that is not value-added to the patient (waste in lean terms) ultimately inhibits true patient value - the delivery of the right product, at the right time, at the right cost. Waste commonly results from a perceived risk of non-compliance, when in fact, there can be a leaner approach that does not introduce patient risk. Such activities occur across all aspects of pharmaceutical manufacturing, typified by unnecessary testing/analysis, overly complex documentation, unnecessary rework, inflexibility, etc. This session is meant to challenge our focus and begin the conversation needed for the paradigm shift of “more” in the name of compliance is not necessarily better for the patient, nor is lean contrary to assurance of quality. Participants will have the opportunity to submit situations of value vs fear of non-compliance for panel discussion.
Vivianne Arencibia, Arencibia Quality Compliance Associates
Mahesh Ramanadham, Pharm.D./M.B.A., RPh, Senior Scientific and Policy Advisor (Acting), Office of Process and Facilities, FDA/CDER/OPQ
Eric Thostesen, Sr. Director Regulatory Compliance, Strategic Business Support, Janssen Pharmaceuticals
Timothy Watson, PhD, Executive Director and Team Leader, CMC Advisory Office, Pfizer Inc.