Challenges in Analytical Method Validations and Transfers: Bio and Pharm Joint Session

Moderator(s)

• 

  Sachin Lohani, Ph.D.

  Director
  Merck & Co., Inc.
  Rahway, New Jersey

Presentations:

• 8:05 AM – 8:35 AM CST

  Strategies for Overcoming Challenges with Bioanalytical Method Transfers
  

  Speaker: Amanda L. Hays, PhD – BioAgilytix
• 8:35 AM – 9:05 AM CST

  Strategies for the Modernization of Legacy Transfer Methods
  

  Speaker: Erik Jerks, B.S. – Eurofins Pharma Bioanalytics Services, LLC
• 9:05 AM – 9:35 AM CST

  Risk Assessment for Lab Training and Readiness Prior to Method Transfer  
  

  Speaker: Joselito Gonzalez, MS Quality Engineering (he/him/his) – Organon
• 9:35 AM – 10:05 AM CST

  Lessons Learned from Registrational Analytical Methods Transfer and Validation at External CMOs in Support of Drug Substance Processes
  

  Speaker: Peter I. Tattersall, PhD (he/him/his) – Analytical Strategy & Operations / Bristol Myers Squibb
• 10:05 AM – 10:35 AM CST

  Joint Session: Panel Discussion
  

  Speaker: Amanda L. Hays, PhD – BioAgilytix

  Speaker: Erik Jerks, B.S. – Eurofins Pharma Bioanalytics Services, LLC

  Speaker: Joselito Gonzalez, MS Quality Engineering (he/him/his) – Organon

  Speaker: Peter I. Tattersall, PhD (he/him/his) – Analytical Strategy & Operations / Bristol Myers Squibb

  Moderator: Sachin Lohani, Ph.D. – Merck & Co., Inc.
• 10:35 AM – 10:40 AM CST

  Closing Remarks
  

  Moderator: Lynn Kamen, PhD – BioAgilytix Labs