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2024 Combo Products Summit Agenda

session

Harmonizing U.S. FDA’s QMSR to ISO 13485: Impact to Combination Product

October 9, 2024 @ 10:25 am

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11:25 am

Moderators

Bonnie OdomPartner in the Healthcare and Life Sciences Practice, Epstein Becker & Green

Tine Albeck, Senior QA Professional, ALK A/S

Speaker

Nik Thakur, Senior Program Manager, Quality and Compliance, Center for Devices and Radiological Health,(CDRH), FDA (Invited)

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.

This conference IS co-sponsored by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services. The contents are those of the presenters and do not necessarily represent the official views of, nor an endorsement by, FDA/HHS or the U.S. government.

The AFDO/RAPS Healthcare Products Collaborative is a joint venture established in 2022 between the Association of Food and Drug Officials and the Regulatory Affairs Professionals Society. Learn more.

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