cGMP Expectations for Drug-led versus Device-led Combination Products Webinar

by Gilero June 4, 2024

Speakers on this webinar discuss the combination product CGMP operating system requirements that support development, manufacturing, premarket regulatory evaluation, and commercialization of combination products.

Combination products are therapeutic or diagnostic medical products that combine drugs, devices, and/or biological products with one another. The FDA regulation of combination products, 21 CFR Part 4, became effective 22 July 2013. Final guidance on CGMPs for combination products was issued in January 2017, and a list of alternative or streamlined mechanisms for compliance with CGMPs for combination products was later issued in September 2022.

Speakers Include:

• Susan Neadle, MS, BS, FRAPS, FAAO, President, Combination Products Consulting Services LLC
• Hope Tuck, VP, Quality & Compliance, Gilero
• Jim Fentress, Director of Regulatory Affairs, Gilero

About the Author

Gilero Gilero specializes in the design, development, and contract manufacturing of medical, drug delivery, and diagnostic devices, bringing innovative healthcare solutions to market. The team combines engineering expertise with a deep understanding of regulatory requirements.