FDA Quality Management Maturity Program Overview, presented by Shabas Solutions and the BioMaP-Consortium

Join Somnath Mishra, President, and William Hauck, Senior Associate at Shabas Solutions, for a one-hour session exploring the fundamentals of the FDA’s Quality Management Maturity (QMM) initiative for pharmaceutical manufacturers.

Key takeaways include:

• What QMM is, how it differs from cGMP regulations, and how it goes beyond established quality frameworks like ICH Q10 and ISO 9001:2015
• The key drivers of change—quality culture and supply chain resilience—and how the program is expected to shape the future of the pharmaceutical industry
• The business case for QMM adoption and practical steps to prepare

Shabas Solutions, a small business consultancy focused on the intersection of public health, life sciences, and regulation, has played an active role in the FDA’s QMM efforts. The firm has contributed subject matter expertise to help develop the initial QMM framework and assessment process used in the FDA’s pilot program for foreign API manufacturers.

This session will deliver practical insights and key takeaways you won’t want to miss. We look forward to your participation.