Challenges in Analytical Method Validations and Transfers

Moderator(s)

• 

  Landon Greene, PhD (he/him/his)

  Senior Director, Analytical Development
  Vertex Pharmaceuticals
  Norwell, Massachusetts

Presentations:

• 1:35 PM – 2:05 PM CST

  Pitfalls in Underpowered and Poorly Designed Validation Studies
  

  Speaker: Steven Walfish, MA MBA (he/him/his) – Statistical Outsourcing Services
• 2:05 PM – 2:35 PM CST

  Transferring an AAV Genome Titer Method - Lessons and Keys to Success
  

  Speaker: Sabine Wenzel, PhD (she/her/hers) – Eli Lilly
• 2:35 PM – 3:05 PM CST

  Transfer of Analytical Procedures as Part of the Method Lifecycle: USP Chapters <1224> and <1220>
  

  Speaker: Margareth R. Marques, MS, PhD (she/her/hers) – U. S. Pharmacopeia