From Development to GMP (products life-cycle, Approval)

University Assigned Professor Module: Ass. Prof. (Nika Mouzaki)

 

The students will be exposed to the steps necessary to push an advance therapy all the way from lab environment to market commercialization. What considerations are needed in each step of the way to commercialization.

The life cycle

Quality by Design (QbD)

Qualification and Validation

Ongoing Process Verification and Lifecycle Approach of a Process established from QbD Principles

IND and CTAs

Case study