Building a Quality Organization

While pharmaceutical GMPs and their associated guidelines recommend a quality unit that is independent of the manufacturing unit, they give little or no information on its organizational construct. This session will explore how to build a pharmaceutical quality system to meet ICH Q10 expectations to “assure the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded.”

Additionally, the speakers will address how to build an organization with a sustainable quality culture and meet all necessary compliance requirements internationally. Senior leaders from a start-up company (Phlow), a spin-off company (Organon), and a rapidly growing company (Moderna) will discuss how to balance addressing compliance needs and planning for expanding roles, commensurate with evolving company capabilities and capacity.