This course will address complexities in combination products (regulatory, business and quality processes) and break them down into their simple elements. Then these elements will be rebuilt into a practical system that will enhance understanding of the requirements. This understanding of requirements will provide you with the tools you need for developing or revamping your quality system to meet this new paradigm. This will result in a smoother development and approval for your product as well as prevent any "big showstoppers" that delay or threaten your project.

Learning Objectives:

• Combination products, as its name implies, is to FDA regulated products which have different modes of action, in the diagnosis and treatment of disease. The most complex frequent is the drug & device combination.
• Provide an understanding of the differences within the various types of combination products.
• More similarities than differences exist between the GMP's for Drugs and Devices. Principles of all quality systems are the same.
• Only one quality system is required to control manufacturing, testing of combination products.
• Quality Systems for medical devices are more quality system orientated than drug GMP's but the drug GMP's are now advancing.
• The lifecycle differences between drugs and devices impact their approval and regulation.
• Staffing for combination products is much more complex than single products.
• The FDA's draft GMP guidance will be incorporated as applicable. This course is designed to better show specific similarities and differences between manufacturing single and combination products.