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Wednesday, Apr 22nd
8:00 AM - 8:30 AM East Coast USA Time
Let's Make a Difference
Location: Regency Ballroom - 3rd Floor
Plenary
Wednesday, Apr 22nd
9:00 AM - 9:45 AM East Coast USA Time
Solutions exchange: What Works (and what doesn’t) When Working With AI in QA/RA
Location: Regency Ballroom - 3rd Floor
Moderator: Gert Bos – Qserve Group
Moderator: John Krug – Eli Lilly and Company
Plenary
Wednesday, Apr 22nd
10:05 AM - 10:40 AM East Coast USA Time
FDA OII and Office of Medical Device & Radiological Health
Location: Regency Ballroom - 3rd Floor
Moderator: Susan Matthias – FDA
Speaker: Anne P. Reid – FDA
Plenary
Wednesday, Apr 22nd
10:40 AM - 11:40 AM East Coast USA Time
Medical Device User Fee Amendments (MDUFA) Update
Location: Regency Ballroom - 3rd Floor
Moderator: Bill Brodbeck – STERIS Corporation
Moderator: Heather Rosecrans – MDMA & ELIQUENT Life Sciences
Speaker: Mark Leahey – Medical Device Manufacturers Association (MDMA)
Speaker: Barb Marsden – FDA (Virtual)
Plenary
Wednesday, Apr 22nd
3:45 PM - 4:45 PM East Coast USA Time
Managing Material Shortages in a Global Regulatory Landscape
Location: Regency Ballroom - 3rd Floor
Moderator: Shannon Hoste – Pathway for Patient Health
Moderator: Aaron Dunbar – Boston Scientific
Speaker: Gert Bos – Qserve Group
Speaker: Tammy Beckham – FDA (Virtual)
Speaker: Dennett Kouri – Edwards Lifesciences
Plenary
Wednesday, Apr 22nd
4:45 PM - 4:50 PM East Coast USA Time
Close Out
Location: Regency Ballroom - 3rd Floor
Plenary
Thursday, Apr 23rd
8:00 AM - 8:10 AM East Coast USA Time
Day 2 Open
Location: Regency Ballroom - 3rd Floor
Plenary
Thursday, Apr 23rd
8:10 AM - 8:45 AM East Coast USA Time
QMSR Implementation Update
Location: Regency Ballroom - 3rd Floor
Moderator: Susan Matthias – FDA
Speaker: Karen Masley-Joseph – FDA
Speaker: Keisha Thomas – FDA
Plenary
Thursday, Apr 23rd
8:45 AM - 10:10 AM East Coast USA Time
Updated Compliance Program (CP) for Inspection of Medical Device Manufacturers
Location: Regency Ballroom - 3rd Floor
Moderator: Susan Matthias – FDA
Speaker: Gina Brackett – FDA
Speaker: Michelle Glembin – FDA
Speaker: Bryan Love – FDA
Speaker: Karen Masley-Joseph – FDA
Speaker: Debbie Reese – FDA
Speaker: Keisha Thomas – FDA
Plenary
Thursday, Apr 23rd
3:20 PM - 4:35 PM East Coast USA Time
Global Regulatory Collaboration/Reliance Strategies, Alignment Challenges & “Relianomics” for Medical Devices
Location: Regency Ballroom - 3rd Floor
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
Speaker: Lawrence Liberti – D.K. Kim International Center for Regulatory Sciences at USC Officer
Speaker: Olga van Grol-Lawlor – Boston Scientific (Virtual)
Speaker: Diane Wurzburger – GE Healthcare
Plenary
Thursday, Apr 23rd
5:05 PM - 5:15 PM East Coast USA Time
Day 2 Close
Location: Regency Ballroom - 3rd Floor
Plenary
Friday, Apr 24th
8:00 AM - 8:05 AM East Coast USA Time
Opening Day 3
Location: Regency Ballroom - 3rd Floor
Plenary
Friday, Apr 24th
8:05 AM - 9:05 AM East Coast USA Time
How You Can Influence and Support Leadership and a Quality Culture in your Organization
Location: Regency Ballroom - 3rd Floor
Moderator: Kim Trautman – Medical Device, IVD and Combo Product Expert
Speaker: Philip Desjardins – Arnold Porter
Speaker: Heather Howell – Fresenius Medical Care
Speaker: Jennifer Paine – Johnson & Johnson
Speaker: James Wabby – AbbVie, Inc.
Plenary
Friday, Apr 24th
9:05 AM - 9:40 AM East Coast USA Time
Update from CDRH's New Center Director
Location: Regency Ballroom - 3rd Floor
Moderator: Gina Brackett – FDA
Speaker: Michelle Tarver – FDA (Virtual)
Plenary
Friday, Apr 24th
10:00 AM - 12:00 PM East Coast USA Time
Investigator Insights
Location: Regency Ballroom - 3rd Floor
Moderator: Monica Wilkins – Abbott
Speaker: Christina Bigham – FDA
Speaker: Laureen Geniusz – FDA
Speaker: Katelyn Staub-Zamperini – FDA
Speaker: Jeffrey Wooley – FDA
Plenary