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Speakers

FDA and EU Regulations • Connectivity Devices and Combination Products • Surveillance • Thresholds

June 19-21, 2018
  • Alexandria, VA

Khaudeja Bano
Senior Medical Director, Medical Device Safety Head
Abbott

Susan Busse
Advisor, Global Product Complaints
Eli Lilly & Company

T. Che Jarrell, BSPH, MPIA, RAC
Proprietor and Principal Consultant
Milestone Regulatory Experts, LLC

Rikke Lewinsky
Specialist, Post market surveillance
Novo Nordisk A/S

Ron Makar, CBA, CHA, CQA, CQE, CMQ-OE (ASQ)
Owner & Principal Consultant
Innovative Quality Consulting, LLC

Kari Miller
Vice President, Regulatory and Product Management
Pilgrim Quality Solutions

Sonny Nguyen
Director, QA/RA
PeriGen, Inc

Alex Patterson
Director, Post Market Quality
ResMed

Sharon Perez
Director, Global Medical Safety
Novocure

Lawrence S. Perruzza, MSc, RAC
Director, Case Investigation & Resolution
Roche Molecular Diagnostics

Vaishali Shukla, MSC, MS, MS
Head of Clinical QA and Product Quality Management
uniQure

Chris Silvers
Vice President of Quality Assurance & Compliance
Vyaire Medical

Khaudeja Bano
Senior Medical Director, Medical Device Safety Head
Abbott

Susan Busse
Advisor, Global Product Complaints
Eli Lilly & Company

T. Che Jarrell, BSPH, MPIA, RAC
Proprietor and Principal Consultant
Milestone Regulatory Experts, LLC

Rikke Lewinsky
Specialist, Post market surveillance
Novo Nordisk A/S

Ron Makar, CBA, CHA, CQA, CQE, CMQ-OE (ASQ)
Owner & Principal Consultant
Innovative Quality Consulting, LLC

Kari Miller
Vice President, Regulatory and Product Management
Pilgrim Quality Solutions

Sonny Nguyen
Director, QA/RA
PeriGen, Inc

Alex Patterson
Director, Post Market Quality
ResMed

Sharon Perez
Director, Global Medical Safety
Novocure

Lawrence S. Perruzza, MSc, RAC
Director, Case Investigation & Resolution
Roche Molecular Diagnostics

Vaishali Shukla, MSC, MS, MS
Head of Clinical QA and Product Quality Management
uniQure

Chris Silvers
Vice President of Quality Assurance & Compliance
Vyaire Medical