Essential Characteristics of a Stage-Appropriate Quality System

Biopharmaceutical companies developing innovative products must build a stage-appropriate quality system (QS) that ensures the right controls are in place.  By doing this, they ensure patient safety and compliance while enhancing operational efficiency. The challenge is in establishing an appropriate level of rigor and controls for the particular stage of the development lifecycle. 

From the identification of critical characteristics to the development of methods and procedures, flexibility and discretion early in development give way to more rigorous controls for commercial GMP operations.

The QS journey begins with steps leading to IND submission. As companies progress through Phase 2 clinical trials and are preparing for a Phase 3 trial, BLA/NDA submission, PAI readiness and ultimately commercialization, they need to progressively enhance their quality system. After product approval, companies continue improving their QS for operational efficiency, as well as to avoid costly product failures and regulatory sanctions.   

They must design and transition to a commercial quality system to support the new operations involved in scaling production, often via outsourcing, while continuing to manufacture clinical material.

Participants will hear expert discussion focused on three main phases of QS development:      

1. Creating a quality system suitable for IND submission and clinical trials 
2. Incremental development of a GMP quality system to prepare for Phase 3 and commercial 
3. How to adjust a QS to business needs after product approval 

This webinar is appropriate for CXOs, Quality, Development, Regulatory, Clinical Operations, Manufacturing, Supply Chain, Technical Operations, and other functional leads engaged with or interested in the stage-appropriate quality system for companies in preclinical development to commercial operations.