Full Schedule

7:00am - 8:00am East Coast USA Time

020 - Breakfast

7:00am - 5:00pm East Coast USA Time

021 - Registration

8:00am - 8:10am East Coast USA Time

022 - Day 2 Open

8:10am - 10:10am East Coast USA Time

023 - QMSR Implementation Update

8:45am - 10:10am East Coast USA Time

024 - Updated Compliance Program (CP) for Inspection of Medical Device Manufacturers

10:10am - 10:30am East Coast USA Time

025 - BREAK

10:30am - 12:30pm East Coast USA Time

026 - Breakout #1: The Mechanics of an FDA Inspection: A View from Many Perspectives

10:30am - 11:30am East Coast USA Time

027 - Breakout #2: Horizontal legislation in EU, a complex growing web of supporting legislation

11:30am - 12:30pm East Coast USA Time

028 - Breakout #2: EU MDR – State of Play and Targeted Revisions

12:30pm - 1:30pm East Coast USA Time

029 - LUNCH

1:30pm - 3:00pm East Coast USA Time

030 - Breakout #1: CDRH Premarket Update

1:30pm - 3:00pm East Coast USA Time

031 - Breakout # 2: Bringing New Products to Life Compliantly: Challenges in Design Development

3:00pm - 3:20pm East Coast USA Time

032 - BREAK

3:20pm - 4:35pm East Coast USA Time

033 - Regulators: Global Harmonization and Convergence Initiatives

4:35pm - 5:05pm East Coast USA Time

034 - Patient Experience Plenary #2

5:05pm - 5:15pm East Coast USA Time

0.35 - Day 2 Close

5:15pm - 6:30pm East Coast USA Time

036 - Networking Reception