Over the last five years, management controls made up approximately 15% of all warning letters by subsystem annually. There is a scarcity of information and presentations on management controls even though it is the most important aspect of the quality system. This presentation will detail the importance of management controls in driving a quality organization.

It is up to management to ensure that an effective and sustainable quality system is implemented appropriate to the organization’s products and processes. Management should set the vision, strategy and goals, and this should be communicated to everyone within the organization. Leading by example and focusing on quality are keys to success. This audio conference presentation looks at how effective management controls lead to successful quality-centric and profitable organizations, as our speaker shares organizational best practices in this key area.

This audio conference covers:

• The significance of management controls across an organization’s entire quality system
• What makes for effective management controls in an organization?
• The constant clash between business requirements and quality needs
• Elements of management controls including quality policy, quality planning and resource management
• Barriers to effective management controls
• Best practices that lead to effective management controls

About the speaker:

Dr. Vinny Sastri is the president of WINOVIA® LLC, a company that provides customized solutions, strategies, and implementation of effective product life cycle management and quality management processes. Areas of expertise include product design and development, design controls, process validation, FDA and ISO quality systems for medical devices and pharmaceuticals, manufacturing, risk management, CAPA, and plastics and materials.

He is a certified Six Sigma black belt and is also on the faculty of the Association for the Advancement of Medical Instrumentation (AAMI) that provides training on the FDA Quality Systems Regulation and Industry Practice to the medical device industry. Dr. Sastri’s book “Plastics in Medical Devices: Properties, Requirements and Applications” was released on April 1st, 2010 by Elsevier, London.

Who should attend?

• Purchasing Managers
• Supplier Quality Engineers and Managers
• Quality Managers and Engineers
• Regulatory Managers
• R&D
• Validation Engineers