Who Is Involved in PQLI®

Resources by Topic

Product Quality Lifecycle Implementation^® (PQLI^®) Management Committee (MC) and Technical Committee (TC) members are:

Charles P. Hoiberg, PhD (Chair MC)
David W. Selby, PhD ( MC)
John C. Berridge, PhD ( PQLI Project Manager, MC, TC)
Bruce Davis, (Technical Team Leader, TC)
Ranjit R. Deshmukh, PhD (Technical Team Leader, TC)
Joe Famulare (Technical Team Leader, MC, TC)
Rob Hughes (Technical Team Leader, TC)
John Lepore, PhD (Technical Team Leader, TC)
Line Lundsberg, PhD (Technical Team Leader, TC)
Roger Nosal (Technical Team Leader, TC)
Christopher J. Potter, PhD (Technical Committee Co-Chair, PQLI Technical Project Manager, MC)
Christopher Sinko, PhD (Technical Team Leader, TC)
Stephen Tyler, (Technical Committee Chair, MC)
Gretchen Allison, (Technical Team Leader, TC)
Joanne Barrick, (Technical Team Co-Leader, TC)

Dozens of industry leaders participate in various Task Teams, led by:

Biotechnology Task Team - Ranjit R. Deshmukh, MedImmune (Chair)
Design Space Task Team - John Lepore, Merck (Chair)
Illustratrative Example Task Team - Bruce Davis, Global Consulting (Chair)
Integration Task Team - Christopher M. Sinko, BMS (Chair)
Process Performance and Product Quality Monitoring System Task Team - Joe Famulare, Genentech (Chair)
Change Management System Task Team - Rob Hughes, AstraZeneca (Chair)
Critical Quality Attributes and Critical Process Parameters Task Team - Roger Nosal, Pfizer (Chair)
Control Strategy Task Team - Line Lundsberg-Nielsen, NNE Pharmaplan (Chair)
Existing Products Task Team - Christopher J. Potter, CMC Consultant (Chair)
Process Validation Task Team – Gretchen Allison, Pfizer (Chair) and Joanne Barrick, Eli Lilly (Co-Chair)
Technical Writer - Sion Wyn, Conformity Ltd