Catalent Quality Expert Presents At 2012 ICH Q10 Workshop




Catalent Quality Expert to Present At the 2012 PDA/FDA Pharmaceutical Quality Systems (ICH Q10) Workshop

Somerset, NJ, September 6, 2012 – Swroop Sahota, Vice President, Global Quality Operations at Catalent Pharma Solutions will present “Quality Management Systems: An Enabler of Culture Change” at the 2012 PDA/FDA Pharmaceutical Quality Systems (ICH Q10) Workshop” on September 13, 2012 in Baltimore, MD.

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 both manufacturing 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.

For more information on this course and to register, please visit: www.pda.org

To schedule an interview with Dr. Sahota during or after the workshop, please contact Patricia McGee at media@catalent.com .

About Catalent

Catalent Pharma Solutions is the global leader in development solutions and advanced drug delivery technologies, providing world-wide clinical and commercial supply capabilities for drugs, biologics and consumer health products.  With over 75 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable product supply. Catalent employs 9,000 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and generates more than $1.6 billion in annual revenue. Catalent is headquartered in Somerset, N.J.

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