The concept of quality systems and design control has been around for over 15 years. Implementing a good quality system correctly is not only required for regulatory compliance, but it makes good business sense as well. However, for many companies, and especially small companies, implementing a system that doesn’t create stifling bureaucracy can be a real challenge. How and when a company implements a quality system can mean the difference between long-term success and a slow, painful path to market..

This audio conference presentation looks at the issue of implementing a quality system and design control for in vitro diagnostics, helping attendees to better understand the steps and components in the process, as well as the benefits of getting it right.

This audio conference covers:

• An understanding of the major components of a quality system
• When you need to implement these components
• The role of management in a successful quality system implementation process
• How having a quality system in place can give you a competitive advantage

About the speaker:

David Kern, RAC MBA is Senior Director with Myraqa, a full-service IVD regulatory consulting firm. Dave has nearly 20 years of experience developing IVD and life science products. His experience in product development, project management, business development and relationship management grants him a wide view of the entire life-cycle management process. He has designed and implemented product development processes for both FDA and ISO environments, in both large and small companies. He also has extensive experience in creating and implementing governance structures to manage co-development and outsourcing relationships within both the IVD and therapeutics industries.

Dave holds a BS in Biochemistry from San Francisco State University, and a MBA from San Jose State University. He has extensive training in project management, facilitation and conflict resolution, and holds a Regulatory Affairs Certification.

Who should attend?

• Regulatory Affairs
• Quality
• Clinical Affairs