Combination product manufacturers are faced with a major challenge to implement a quality system that complies with applicable FDA Good Manufacturing Practices (GMPs) and Quality System Requirements (QSRs). For 10 years, FDA has been progressively developing regulations for this complex area, yet has provided very few formal guidance documents to help manufacturers.

In this audio conference, you’ll learn how to navigate the regulations to develop effective plans for combination products. Linda Alexander gives you specific examples of current FDA expectations and accepted practices, and teaches you how to customize and apply them to comply. Explore the history of combination approvals in the US, case studies, and important trends and issues for the future.

This audio conference covers:

• Details of FDA guidance
• Strategies to address and implement requirements
• Best practices for communicating with FDA
• How to manage the FDA pre-approval inspection
• Trends in combination product regulation
• Where to go for current information

About the speaker:

Linda Alexander founded Alquest, the first dedicated medical device CRO, in 1993. What started with a vision to provide comprehensive, integrated services to device manufacturers, has now expanded to include regulatory, clinical, and compliance services for device, biologics, and combination products both nationally and internationally. She is noted for her strategic regulatory and clinical insights and has personally supported more than 100 product approvals.

Alexander’s experience includes all classes and types of products, including combinations such as coated stents and iontophoretic drug delivery systems. An experienced trainer and public speaker, as well as quality system advisor, she is often requested to present at national conferences on topics such as combination product regulation, product approval submissions, global strategies, and FDA enforcement issues. She has a B.S. in Biology from Iowa State University and M.S. in Technical Communications from the University of Minnesota.

Who should attend?

• Companies developing or preparing to develop combination products
• Director/VP/Manager Quality Assurance
• Director/VP/Manager Regulatory Affairs
• Director/VP/Manager Product Development
• Other middle to senior management

This audio conference is rated General Interest.

*Please note: Each registration covers one line connected to the audio conference. Attendees dialing from separate locations are required to have separate registrations.