In January 2013 FDA released the long-sought after rules for cGMPs for combination products.
These rules that had been in the works for about 8 years clarified several confusions about FDA expectations regarding GMP requirements for products that may be subject to multiple GMP requirements from drugs, biologics and medical devices depending on their components. In the final rule, FDA clarified the acceptable definitions, described the applicable regulations, and provided advice on which GMP requirements to follow for a given product. The final rule also defined FDA’s expectation for co-packaged or single-entity combination products.
Developers and manufacturers of combination products are required to follow these rules starting 22 July 2013. Are you ready?
Certainly, with this healthcare session! Our expert Dr. Mukesh Kumar will discuss the final rule for GMP requirements for combination products highlighting the key elements of the rule and practical tips for compliance. FDA’s rationale for various requirements and expectations of manufacturing sites involved in combination products will be discussed using examples and case studies.
Here are a few highlights of the session:
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Who should attend?
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
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