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Wednesday, Apr 22nd
1:15pm - 2:15pm East Coast USA Time
Breakout #2: De-Mystifying Verification and Validation of Manufacturing Processes
Moderator: Susan Matthias – FDA (Invited)
Breakout
Wednesday, Apr 22nd
1:15pm - 3:15pm East Coast USA Time
Breakout #1: Overcoming Challenges in Medical Device Design and Development
Moderator: Bill Brodbeck – STERIS Corporation
Moderator: Aaron Dunbar – Boston Scientific
Moderator: John Krug – Eli Lilly and Company
Breakout
Wednesday, Apr 22nd
2:15pm - 3:15pm East Coast USA Time
Breakout #2: Identifying & Handling Product Software Defects / Bugs / Anomalies
Breakout
Wednesday, Apr 22nd
3:15pm - 4:00pm East Coast USA Time
Breakout #1: Embracing AI to Build a Better Operation and QMS
Speaker: Eric Henry – Brooke & Associates
Breakout
Wednesday, Apr 22nd
3:15pm - 4:00pm East Coast USA Time
Breakout #2: Managing Data Integrity Across the Total Product Lifecycle
Moderator: Sean Boyd – QualityHub, Inc.
Breakout
Thursday, Apr 23rd
10:30am - 11:30am East Coast USA Time
Breakout #2: EU MDR – State of Play and Targeted Revisions
Moderator: Gert Bos – Qserve Group
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
Breakout
Thursday, Apr 23rd
10:30am - 12:30pm East Coast USA Time
Breakout #1: The Mechanics of an FDA Inspection
Breakout
Thursday, Apr 23rd
11:30am - 12:30pm East Coast USA Time
Breakout #2: Horizontal Legislation in EU, A Complex Growing Web of Supporting Legislation
Moderator: Gert Bos – Qserve Group
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
Breakout
Thursday, Apr 23rd
1:30pm - 3:00pm East Coast USA Time
Breakout # 2: Quality beyond the factory’s walls: Managing Supplier Risk and Quality From Off-the-Shelf to Custom Contract Manufactured Products
Moderator: Gina Bracket – FDA (Invited)
Moderator: John Krug – Eli Lilly and Company
Moderator: Susan Matthias – FDA (Invited)
Breakout
Thursday, Apr 23rd
1:30pm - 3:00pm East Coast USA Time
Breakout #1: CDRH Premarket Update
Moderator: Heather Rosecrans – MDMA & ELIQUENT Life Sciences
Breakout