AABME is conducting a series of webinars to examine a risk-based, conceptual framework developed by the US Food and Drug Administration (FDA) for use at point-of-care manufacturing facilities. Webinar panels will include speakers from diverse groups, including medical device manufacturers, point-of-care manufacturers, technology developers, and the FDA. The framework includes the following scenarios: A. Minimal Risk 3DP by a Healthcare Professional B&C. Device Designed by Manufacturer Using Validated Process D. Manufacturer Co-Located at Point of Care E. Healthcare Facility Becomes a Manufacturer
AABME is conducting a series of webinars to examine a risk-based, conceptual framework developed by the US Food and Drug Administration (FDA) for use at point-of-care manufacturing facilities. Webinar panels will include speakers from diverse groups, including medical device manufacturers, point-of-care manufacturers, technology developers, and the FDA. The framework includes the following scenarios:
Introduction to Framework - December 18, 2019
A. Minimal Risk 3DP by a Healthcare Professional - January 21, 2020
B&C. Device Designed by Manufacturer Using Validated Process - February 20, 2020
D. Manufacturer Co-Located at Point of Care - March 19, 2020
E. Healthcare Facility Becomes a Manufacturer - April 2020
Past webinars are available for on demand viewing.