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Mandernach, Steven
Association of Food and Drug Officials (AFDO)
Let's Make a Difference!
Location: Regency Ballroom – 3rd Floor
Steven Mandernach
Markley, Evan
Eli Lilly and Company
Risk Management - Systems Perspective
Location: Regency Ballroom – 3rd Floor
Evan Markley
The Device Design Change Life Cycle Experience
Location: Franklin B – 2nd Floor
Evan Markley
Masley-Joseph, Karen
FDA (Virtual)
FDA’s QMSR Implementation Status
Location: Regency Ballroom – 3rd Floor
Karen Masley-Joseph
Matthias, Susan
FDA (Virtual)
FDA Medical Device Inspections
Location: Regency Ballroom – 3rd Floor
Susan Matthias
Investigator Insights
Location: Regency Ballroom – 3rd Floor
Susan Matthias
McCann, Mindy
Qserve Group
Global Shift in Clinical Expectations
Location: Regency Ballroom – 3rd Floor
Mindy McCann
McMoil, Bill
Regulatory Affairs Professionals Society, RAPS (Welcome)
Let's Make a Difference!
Location: Regency Ballroom – 3rd Floor
Bill McMoil
Mecl, Rhonda
FDA (Virtual)
FDA Medical Device Inspections
Location: Regency Ballroom – 3rd Floor
Rhonda Mecl
Millner, LCDR Mary
FDA (Virtual)
Investigator Insights
Location: Regency Ballroom – 3rd Floor
LCDR Mary Millner
Murray, Clarence
STERIS Corporation
Breakout #3: Addressing 510(k) Review Challenges
Location: Regency Ballroom – 3rd Floor
Clarence Murray
Murray, David
Illumina
Breakout #1: Optimizing Regulatory and Design Strategies for LDTs and IVDs with Different International Requirements
Location: Delaware AB – 2nd Floor
David Murray
Risk Management - Systems Perspective
Location: Regency Ballroom – 3rd Floor
David Murray
