In a 46-page draft guidance released in January, the FDA clarified a 2013 final rule that specifies how combination product manufacturers should comply.
The FDA says combination product manufacturers have two options for GMP compliance: satisfy all device and drug GMPs, or implement a streamlined quality system that focuses primarily on one but incorporates elements of the other. This report will guide manufacturers in developing a strategy that makes not only good compliance sense but also good business sense.
The new management report from FDAnews will teach you all you need to know to successfully manufacture your product. You will learn:
How to make the best use of the FDA draft guidance released in January that clarifies a 2013 final rule on combination products;
What to look for in current processes and procedures and how to meld drug GMPs and device QSRs smoothly to ensure compliance;
Key inputs to developing your compliance strategy, which include:
Product risks and their effect on the product portfolio;
How much of your manufacturing is outsourced;
Complexity of the combination product being produced;
Whether the product this an NDA line extension or new application; and
Whether a predicate device exists or will the product be a PMA.
Whether you need to update any of your supplier agreements or SOPs in light of the FDA’s latest combination product guidance;
How combination product makers should work with the FDA; and
How to deal with changes to a combination product after approval for marketing to maintain compliance.
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Table of Contents
Developing a Compliance Strategy
Impact of Business Processes on the Compliance Strategy
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