Optimized Operational Excellence (OpEx) Infrastructure for 21st Century cGMP Manufacturing and Quality Operations

Linking Critical Quality Attributes (CQAs) and Critical Process Parameter (CPPs) to Improve Plant Costs, Productivity and Cycle Times

March 11, 2010
11:00 a.m. eastern standard time (NY time)

Abstract

To thrive in today’s economic and competitive environment, life science manufacturing organizations must focus efforts at reducing costs, improving productivity, and ensuring product quality all while meeting regulatory compliance requirements. Recent regulatory initiatives including “Quality by Design” and ICH Quality System guidelines hint at the importance of capturing, cataloging, and most importantly interpreting the vast amount of operational data being produced every hour of every day. By capturing and linking critical quality attributes (CQA’s) as determined through quality control labs and critical process parameters (CPP’s) from plant floor systems, innovative companies can better manage operations and get a view into operational knowledge for continuous process improvements and effective “right first time” performance at reduced operational costs.

This 45-minute Web briefing will discuss an innovative lab-to-plant quality system and knowledge management technologies currently being deployed by leading life science companies to achieve operational excellence on a harmonized global basis. Key topics will include:

• Automating QC/QA operations yielding 25%+ cost reductions
• Eliminating non-value-added paper-based processes (in plant and lab operations) with 50-75% cycle time reductions in review and approvals
• Capture and linking of MES-based plant data with QC data for effective “event” management
• Finding the hidden process improvement area’s through data capture, review and visualization

Learn how to not only survive, but thrive in the 21st century life science industry. Register for this complimentary Web briefing organized by Gartner today!

Who should attend?

Pharmaceutical and biotechnology executives including:

• VP Manufacturing
• Senior Plant Managers
• VP of Quality
• VP IS/IT Systems for Plant Operations
• Director of QC/QA Operations
• COO and CEO

To register for this complimentary webinar, please complete the form below: