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Quality Digest

FDA Compliance

Bio/Pharmaceutical and Medical Device QA/QC Process Improvement Summit

Published: Wednesday, December 19, 2007 - 23:00

(The Center for Business Intelligence: Woburn, Massachusetts) – CBI will host the conference with the theme, “Implement a Strategy for Continuous Quality Systems Improvement in Accordance with ICH Q10 Guidelines,” January 24–25, 2008, in Philadelphia.ICH Q10 describes one comprehensive approach to an effective pharmaceutical quality system that is based on ISO standards concepts, includes applicable good manufacturing practice (GMP) regulations and complements ICH Q8 “Pharmaceutical Development” and ICH Q9 “Quality Risk Management.” ICH Q10 is a model for a pharmaceutical quality system that can be implemented throughout the different stages of a product lifecycle.

As the medical industry and regulators move toward a greater understanding of the critical components of a comprehensive quality system, industry practitioners are challenged with determining the most effective and efficient means of ensuring quality from the research phase to the production phase of commercial manufacturing.

This conference focuses on industry-specific tools and techniques available for quality assurance and quality control personnel to analyze current procedures and documentation protocols to enhance their regulatory compliance. Through a combination of interactive sessions and workshops this conference provides analyses of the historical elements of quality systems and investigates the opportunities to improve efficiencies and ultimately meet the goal of the ICH Q10 initiative for overall process improvement for quality systems.

Key topics addressed at the conference include:
•   Best practices for integrating quality and risk management to improve efficiency
•   The design and implementation of quality systems
•   Effective process performance and product quality monitoring
•   Applying lean/Six-Sigma principles to quality process improvement
•   How to organize your quality systems for success
•   How to identify opportunities for improvements in your corrective and preventive action (CAPA) system

The conference will also feature benchmarking group roundtable sessions:
•   A. Opportunities for process improvement in the clinical and laboratory environments
•   B. Gaining senior management buy-in/how to engage management for quality systems process improvement
•   C. Effective process performance and product quality monitoring

For more information, visit https://www.cbinet.com/show_conference.cfm?confCode=PC08010&field=summary

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For 40 years Quality Digest has been the go-to source for all things quality. Our newsletter, Quality Digest, shares expert commentary and relevant industry resources to assist our readers in their quest for continuous improvement. Our website includes every column and article from the newsletter since May 2009 as well as back issues of Quality Digest magazine to August 1995. We are committed to promoting a view wherein quality is not a niche, but an integral part of every phase of manufacturing and services.