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Driven by the Regulatory Expectations of Today and the Technologies of Tomorrow

April 23-25, 2019
  • San Diego, CA

Jerry Anderson
Director, Quality Assurance
Ionis Pharmaceuticals

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

Vamsee Dasaka
Senior Manager, Risk and Financial Advisory
Deloitte & Touche LLP

Paola DePaso
Director, Vault Quality
Veeva Systems

Denise Diehr-New
Validation Engineer III
Hikma

Norm Fjeldheim
Senior Vice President, Chief Information Officer
and Global Head of Facilities
Illumina

Michael Gameng
Associate Director, GxP Enterprise Applications
MyoKardia

Senthil Gurumoorthi
Associate Director, IT Quality Assurance
Gilead Sciences

Saurav Ghosh
Consulting Director
NNIT

Calvin Kim
GXP IT Compliance Manager
Bayer

Shana Kinney
Senior Manager, Computer Systems Validation
REGENXBIO Inc.

David Liu
Associate Director
Celgene

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

Christine Foley Nash
Senior Manager, Validation
Kedrion Biopharma Inc.

Satyanarayana Patloori
Managing Director, Risk and Financial Advisory
Deloitte & Touche LLP

Shane Pew
Director of Quality Assurance
Myriad Genetics

Joe Pierce
Founder, CEO
Endpoint Technologies

Cynthia Pleach
Information Technology Compliance and Governance Manager
NewLink Genetics

Loan Quach
Senior Manager, Quality Management Services
Box, Inc.

Doug Shaw, CISA
Director of IT & CSV Consulting
Azzur Group

Ken Shitamoto, MS
Senior Director, IT
Gilead Sciences

Lance Smith
IT Associate Director
Celgene

Jason Spiegler
Senior Director, Industry Portfolio Development
Siemens Product Lifecycle Management Software Inc.

Kurt Weber
Director of IT
Vericel Corporation

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

Jimmy Yeh
Validation Manager, Quality Management Services
Box, Inc.

Joseph Zec
Associate Director, CSV and Compliance
Shire plc

Jerry Anderson
Director, Quality Assurance
Ionis Pharmaceuticals

Harsha Chulki
Head of Global IT Quality & CSV
ICU Medical

Vamsee Dasaka
Senior Manager, Risk and Financial Advisory
Deloitte & Touche LLP

Paola DePaso
Director, Vault Quality
Veeva Systems

Denise Diehr-New
Validation Engineer III
Hikma

Norm Fjeldheim
Senior Vice President, Chief Information Officer
and Global Head of Facilities
Illumina

Michael Gameng
Associate Director, GxP Enterprise Applications
MyoKardia

Senthil Gurumoorthi
Associate Director, IT Quality Assurance
Gilead Sciences

Saurav Ghosh
Consulting Director
NNIT

Calvin Kim
GXP IT Compliance Manager
Bayer

Shana Kinney
Senior Manager, Computer Systems Validation
REGENXBIO Inc.

David Liu
Associate Director
Celgene

Khaled Moussally
Head Quality Management Systems & Managing Partner
Compliance Group

Christine Foley Nash
Senior Manager, Validation
Kedrion Biopharma Inc.

Satyanarayana Patloori
Managing Director, Risk and Financial Advisory
Deloitte & Touche LLP

Shane Pew
Director of Quality Assurance
Myriad Genetics

Joe Pierce
Founder, CEO
Endpoint Technologies

Cynthia Pleach
Information Technology Compliance and Governance Manager
NewLink Genetics

Loan Quach
Senior Manager, Quality Management Services
Box, Inc.

Doug Shaw, CISA
Director of IT & CSV Consulting
Azzur Group

Ken Shitamoto, MS
Senior Director, IT
Gilead Sciences

Lance Smith
IT Associate Director
Celgene

Jason Spiegler
Senior Director, Industry Portfolio Development
Siemens Product Lifecycle Management Software Inc.

Kurt Weber
Director of IT
Vericel Corporation

Chris Wubbolt
Principal Consultant
QACV Consulting, LLC

Jimmy Yeh
Validation Manager, Quality Management Services
Box, Inc.

Joseph Zec
Associate Director, CSV and Compliance
Shire plc