Drug Solutions Podcast: FDA Quality Management Maturity (QMM) Overseas Pilot Program Findings: Going Beyond the Regulations

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In this episode of the Drug Solutions Podcast, Chris Spivey interviews executives at Shabas Solutions LLC, who ran the overseas QMM pilot project.

FDA mentioned QMM in its 2019 report, Drug Shortages: Root Causes and Potential Solutions, which pointed to a lack of manufacturer incentives to improve their quality management beyond the minimum required for current good manufacturing practice (CGMP) compliance. In this podcast learn what QMM is, and how far beyond GMP functions QMM will drill into, and what accountability senior management bears for sustaining a corporate quality management culture, from an interview with executives at Shabas Solutions LLC, who ran the overseas pilot program.

About the speakers

Somnath Mishra, President, Shabbas Solutions LLC

William Hauck, Senior Associate, Shabbas Solutions LLC

Zachary Royal, Senior Consultant, Shabbas Solutions LLC

Clyde Schultz, Senior Associate, Shabbas Solutions LLC

Robert Michalik, Advisor, Quality and Corporate Compliance, Shabbas Solutions LLC

Shabas Solutions provides Bio-Medical Scientific and Technical Services, Management Advisory Services, Medical Logistics and Supply Chain Management Support, Financial Management Support, Technology Integration, and Training, and Communication and Outreach to Federal Government Agencies. We are recognized for successfully leading large scale, departmental level mission-support operations through our expertise in policy, operations, and systems. As a scientific services provider we offer pharmaceutical consulting across the full lifecycle – drug discovery and development (small molecules and biologics), pharmaceutical manufacturing quality management maturity (QMM), pharmaceutical products storage and distribution, and regulatory affairs. As a responsible contractor, we maintain an ISO 9001:2015 certified quality management system and a DCAA-approved accounting system.

About the Drug Solutions Podcast

Pharmaceutical Technology presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

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