This presentation describes how quality systems and continual improvement fit into the overall quality strategy of a company. The role and involvement of senior management in the development, deployment and improvement of quality systems will also be discussed. The approach to quality systems deployment and the level of engagement and involvement of senior management can enable the development of a quality culture.
The 2012 PDA ICH Q10 Workshop will highlight the recent changes in regulatory compliance trends including warning letters and consent decrees, regulatory expectations for operations and executive management, and how pharmaceutical quality systems can be used to align the company across multiple sites and drive the right quality culture.
Dr. Swroop Sahota is Vice President of Global Quality Operations at Catalent Pharma Solutions. She is responsible for the Validation and Computer Systems Validation (CSV) Centers of Excellence, Global Metrics and Continuous Improvement, Quality IT Systems and Supplier Assurance. Dr. Sahota has been in the pharma industry for almost 25 years. She has held global and regional positions at Merck, Schering Plough and Roche and has managed quality sites in the US, Asia and Latin America. Her experience spans roles in bothmanufacturing and the quality functions; solid oral dosage, sterile, liquids, ointments and inhalation products. She is actively involved in many industry forums and served on the board for Rx 360. Dr. Sahota has been involved as a contributing author of ICH Q10 and served on the ICH IWG for Q8, Q9 and Q10. She holds a Ph.D. in Physical Chemistry from the University of California, San Diego and has an Executive MBA from Rutgers University.
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