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Wednesday, Apr 22nd
12:40 PM - 1:40 PM East Coast USA Time
Breakout #2: De-Mystifying Verification and Validation of Manufacturing Processes
Location: Franklin CD - 2nd Floor
Moderator: Susan Matthias – FDA
Speaker: Michelle Glembin – FDA
Speaker: Tom Peter – FDA
Breakout
Wednesday, Apr 22nd
12:40 PM - 2:40 PM East Coast USA Time
Breakout #1: Overcoming Challenges in Medical Device Design and Development
Location: Franklin AB - 2nd Floor
Moderator: Bill Brodbeck – STERIS Corporation
Moderator: Aaron Dunbar – Boston Scientific
Moderator: John Krug – Eli Lilly and Company
Moderator: Phil Pontikos – FDA Rescue
Speaker: Tracie Capozzio – Philips Healthcare
Speaker: Benjamin Dastoli – FDA Rescue
Speaker: Tony Piotrkowski – STERIS Corporation
Breakout
Wednesday, Apr 22nd
1:40 PM - 2:40 PM East Coast USA Time
Breakout #2: Identifying & Handling Product Software Defects / Bugs / Anomalies
Location: Franklin CD - 2nd Floor
Moderator: Monica Wilkins – Abbott
Speaker: Tom Peter – FDA
Speaker: Jad Wafeeq – Abbott
Breakout
Wednesday, Apr 22nd
2:40 PM - 3:25 PM East Coast USA Time
Breakout #1: Embracing AI to Build a Better Operation and QMS
Location: Franklin AB - 2nd Floor
Moderator: Eric Henry – Brooke & Associates
Speaker: Andy O'Connor – ERA Sciences
Speaker: Curt Wichern – Luova Solutions
Breakout
Wednesday, Apr 22nd
2:40 PM - 3:25 PM East Coast USA Time
Breakout #2: Managing Data Integrity Across the Total Product Lifecycle
Location: Franklin CD - 2nd Floor
Moderator: Sean Boyd – QualityHub, Inc.
Speaker: Donna M. Haire – The Eriah Group / FluoGuide / Sedana Medical / BioPorto
Speaker: Josh Nipper – FDA
Breakout
Thursday, Apr 23rd
10:30 AM - 11:30 AM East Coast USA Time
Breakout #2: EU MDR – State of Play and Targeted Revisions
Location: Franklin CD - 2nd Floor
Moderator: Gert Bos – Qserve Group
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
Speaker: Philippe Auclair – AKRA Team
Speaker: Fabien Roy – Arnold & Porter
Speaker: Andreas Stange – TUV SUD
Speaker: Cécile van der Heijden – Axon Lawyers
Breakout
Thursday, Apr 23rd
10:30 AM - 12:30 PM East Coast USA Time
Breakout #1: The Mechanics of an FDA Inspection
Location: Franklin AB - 2nd Floor
Moderator: Gina Brackett – FDA
Speaker: Bill Brodbeck – STERIS Corporation
Speaker: Eric Henry – Brooke & Associates
Speaker: Melissa Michurski – FDA
Speaker: CDR Cesar Perez – FDA
Speaker: Joseph Strelnik – FDA
Breakout
Thursday, Apr 23rd
11:30 AM - 12:30 PM East Coast USA Time
Breakout #2: Horizontal Legislation in EU, A Complex Growing Web of Supporting Legislation
Location: Franklin CD - 2nd Floor
Moderator: Gert Bos – Qserve Group
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
Speaker: Philippe Auclair – AKRA Team
Speaker: Fabien Roy – Arnold & Porter
Speaker: Andreas Stange – TUV SUD
Speaker: Cécile van der Heijden – Axon Lawyers
Breakout
Thursday, Apr 23rd
1:30 PM - 3:00 PM East Coast USA Time
Breakout #1: CDRH Premarket Update
Location: Franklin AB - 2nd Floor
Moderator: Heather Rosecrans – MDMA & ELIQUENT Life Sciences
Moderator: Bill Brodbeck – STERIS Corporation
Speaker: Clarence Murray, III – STERIS Corporation
Speaker: Josh Nipper – FDA
Speaker: Mike Ryan – Eliquent Life Sciences
Breakout
Thursday, Apr 23rd
1:30 PM - 3:00 PM 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
Location: Franklin CD - 2nd Floor
Moderator: Gina Brackett – FDA
Moderator: John Krug – Eli Lilly and Company
Moderator: Susan Matthias – FDA
Speaker: James Brogan – West Pharmaceutical Services
Speaker: Maria Hult – Roche Diagnostics
Speaker: Debbie Reese – FDA
Speaker: Katelyn Staub-Zamperini – FDA
Breakout