2024 Combo Products Summit Agenda
session
Harmonizing U.S. FDA’s QMSR to ISO 13485: Impact to Combination Products
October 9, 2024 @ 3:50 pm
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4:50 pm
Moderators
Bonnie Odom, Partner in the Healthcare and Life Sciences Practice, Epstein Becker & Green
Tine Albeck, Senior QA Professional, ALK A/S
Speakers
Khaudeja Bano, Past Amgen
Sara Coon, Director Regulatory Affairs, Halozyme, Inc
Nik Thakur, Senior Program Manager, Quality and Compliance, Center for Devices and Radiological Health (CDRH), FDA
FDA released its final rule amending 21 CFR part 820 and part 4 to harmonize with ISO 13485 by reference, a positive step toward harmonization. But what are the specific changes, and how do they impact combination products (cGMP guidance)? This panel will discuss the final rule, FDA’s next steps toward implementation, and how industry can prepare.