Module232025

Change Management within CMC Functions

• Reluctance to implement new technologies and procedures due to potential regulatory and business chase impact • Quality units will evolve to be a more hands-on review of the product attributes • Ability to quickly ascertain the impact of proposed changes or deviations

“Stakeholder Management”

• High demand to understand Critical Quality Attributes (and monitor related Critical Process Parameters) at a molecular level

Invest in Quality Control, best-practice analytics and procedures

Quality (CMC) Development Considerations

The Organisation for Professionals in Regulatory Affairs