Module 3 Presentations

07/05/2024

Changes and Adaptions in CMC CMC is an Iterative Process of Changes and Improvements During Product Development

preclinical

Phase I

Phase II

Phase III

Phase IV/ post approval

Specifications

Analytics/ Controls

Storage

Labelling

Manufacturer

Shipping

Manufacturing process and strategy

Formulation/Containers/Closure

How to address this continuous level of changes in project management?

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

19

What is Agile PM? Waterfall vs Agile

 Instead of extensive planning and design up front, Agile methodologies allow for changing requirements over time  The goal of each iteration is to produce a working product, which can be demonstrated to stakeholders. Feedback can then be incorporated into the next or future iterations.

CMC Project Management

The Organisation for Professionals in Regulatory Affairs

20