28 Pharmaceutical Technology
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Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com
Qualit
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Somnath Mishra,
President, Shabas Solutions LLC
FDA Quality Management Maturity (QMM)
Overseas Pilot Program Findings:
Going Beyond the Regulations
In this episode of the Drug Solutions Podcast, Chris Spivey interviews exec-
utives 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 cur-
rent 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.
For more podcast
episodes, visit our website!
Zachary Royal,
Senior Consultant, Shabas Solutions LLC
Robert Michalik,
Advisor, Quality and Corporate
Compliance, Shabas Solutions LLC
William Hauck,
Senior Associate, Shabas Solutions LLC
Clyde Schultz,
Senior Associate, Shabas Solutions LLC
