C5: All That Data…Now What?

Co-Presenter(s)

• 

  Kir Henrici

  CEO
  The Henrici Group
  Warwick, New York, United States

Moderator(s)

• 

  Sharyl Hartsock

  Associate Vice President, Global Quality Systems
  Eli Lilly and Company
  Avon, Indiana, United States

Panelist(s)

• 

  Travis Frick, MSc

  Senior Director, Manufacturing Operations
  Istari Oncology
  Morrisville, North Carolina, United States
• 

  Kir Henrici

  CEO
  The Henrici Group
  Warwick, New York, United States
• 

  Bethany Rexing, MS

  M&Q Data Management Director
  Eli Lilly and Company
  Indianapolis, Indiana, United States

Presenter(s)

• 

  Travis Frick, MSc

  Senior Director, Manufacturing Operations
  Istari Oncology
  Morrisville, North Carolina, United States

  Presentation Handout
• 

  Bethany Rexing, MS

  M&Q Data Management Director
  Eli Lilly and Company
  Indianapolis, Indiana, United States

  Presentation Handout

Regulatory Panelist(s)

• 

  Atul Agrawal, MS

  Supervisory Consumer Safety Officer, ORA
  U.S. FDA
  East Brunswick, New Jersey, United States

Presentations:

• 13:45 – 14:04 EDT

  Forthcoming PDA Technical Report on Utilizing the Quality Management System to assure Data Integrity
  

  Presenter: Travis A. Frick, MSc – Istari Oncology

  Co-Presenter: Kir F. Henrici – The Henrici Group
• 14:04 – 14:29 EDT

  Maximizing Benefit through Data Criticality Assessments and Process Data Flow Mapping
  

  Presenter: Bethany B. Rexing, MS – Eli Lilly and Company
• 14:29 – 15:15 EDT

  Live Q&A (C5)
  

  Moderator: Sharyl D. Hartsock – Eli Lilly and Company

  Panelist: Travis A. Frick, MSc – Istari Oncology

  Panelist: Kir F. Henrici – The Henrici Group

  Panelist: Bethany B. Rexing, MS – Eli Lilly and Company

  Regulatory Panelist: Atul J. Agrawal, MS – U.S. FDA