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Wednesday, April 22, 2026
7:00 AM - 8:00 AM
East Coast USA Time
01 - Breakfast
7:00 AM - 8:00 AM
East Coast USA Time
Breakfast
Location: Regency Ballroom Foyer - 3rd Floor
7:00 AM - 5:00 PM
East Coast USA Time
02 - Registration
7:00 AM - 5:00 PM
East Coast USA Time
Registration
Location: Regency Ballroom Foyer - 3rd Floor
8:00 AM - 8:30 PM
East Coast USA Time
03 - Let's Make a Difference
8:00 AM - 8:30 AM
East Coast USA Time
Let's Make a Difference
Location: Regency Ballroom - 3rd Floor
Plenary
9:00 AM - 9:45 AM
East Coast USA Time
05 - Solutions Exchange: What Works (and doesn’t) When Working With AI
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
9:45 AM - 10:05 AM
East Coast USA Time
06 - BREAK
9:45 AM - 10:05 AM
East Coast USA Time
BREAK
Location: Regency Ballroom - 3rd Floor
10:05 AM - 10:40 AM
East Coast USA Time
08 - FDA OII and Office of Medical Device & Radiological Health
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
10:40 AM - 11:40 PM
East Coast USA Time
09 - Medical Device User Fee Amendments (MDUFA) Update
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
11:40 AM - 12:40 PM
East Coast USA Time
010 - LUNCH
11:40 AM - 12:40 PM
East Coast USA Time
LUNCH
Location: Delaware A-C - 2nd Floor
12:40 PM - 2:40 PM
East Coast USA Time
011 - Breakout #1: Overcoming Challenges in Medical Device Design and Development
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
12:40 PM - 1:40 PM
East Coast USA Time
012 - Breakout #2: Validation of Manufacturing Process/Systems - Equipment Qualification
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
1:40 PM - 2:40 PM
East Coast USA Time
013 - Breakout #2: Identifying & Handling Product Software Defects / Bugs / Anomalies
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
2:40 PM - 3:25 PM
East Coast USA Time
014 - Breakout #1: Embracing AI to Build a Better Operation and QMS
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
2:40 PM - 3:25 PM
East Coast USA Time
015 - Breakout #2: Data Integrity (e.g. how to set up systems - )
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
3:25 PM - 3:45 PM
East Coast USA Time
016 - BREAK and move back to plenary
3:25 PM - 3:45 PM
East Coast USA Time
BREAK and move back to plenary
Location: Regency Ballroom Foyer - 3rd Floor
3:45 PM - 4:45 PM
East Coast USA Time
017 - Managing Material Shortages in a Global Regulatory Landscape
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
4:40 PM - 4:50 PM
East Coast USA Time
018 - Close Out
4:45 PM - 4:50 PM
East Coast USA Time
Close Out
Location: Regency Ballroom - 3rd Floor
Plenary
6:00 PM - 8:00 PM
East Coast USA Time
019 - MedCon Annual Dinner - Franklin Park Conservatory and Botanical Gardens
6:00 PM - 8:00 PM
East Coast USA Time
MedCon Annual Dinner - Franklin Park Conservatory and Botanical Gardens
Networking Event
