FDA Compliance 2011 - GMP Requirements for Combination Products for the Medical Products Industry

This 5-hr GMP requirements training for Combination Products will help you understand FDA's draft guidance on GMPs for Combination Products and provide practical solutions and tools for revamping your quality system to meet this new paradigm.

Are you or your company confused about the requirements for combination products? Questions such as "Do I need 2 GMP systems?" or "Can the master record be a “hybrid master record?". The FDA has published a draft guidance, “Guidance for Industry and FDA - Current Good Manufacturing Practice for Combination Products (Draft Guidance) which helps explain much of the regulatory thinking. However, it fails to provide the necessary detail needed to develop confidence in the system that will ensure all customer requirements are met.

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.