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A Data-Driven Approach To Managing QMM
The FDA has recently issued a Quality Management Maturity Whitepaper (PDF) describing a desire to objectively rate pharmaceutical manufacturers’ demonstration that each manufacturer follows a business process that assures transparency to regulatory agencies and the marketplace with regard to not only product quality but also its culture regarding continuous improvement. The ideal state is a business process that constantly monitors all aspects of how a product is made to what occurs after release in the marketplace and provides evidence of effective action taken to improve product quality and meet customer needs. This webinar will review the relationship between cGMP, ICD-10 and QMM with the emphasis on how to establish parameters/criteria for evaluating drug development, production, quality, and customer satisfaction using a data driven approach. Adoption of risk management tools, decision support, and criteria selection/justification will be included in the presentation. Rather than looking at the challenge of QMM as an unknown, take the opportunity to define it!
BIO Dr. Mike Kowolenko is Founder & CEO of NoviSystems (https://novi.systems). Prior to NoviSystems, Dr. Kowolenko was the Director of NC State University’s Institute for Next Generation IT Systems, an Industry Fellow in the Center of Innovation Management Studies, and Research Professor in the Department of Computer Science at NCSU. Before NCSU, Dr. Kowolenko was Senior Vice-President of Technical Operations and Product Supply in Wyeth’s (Pfizer) Biotechnology and Vaccine Division.