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

Join the webinar to help prepare for QMM. Learn how corporate culture incentives, confidential assessments, rating systems, and quality issues relate to C Suite decisions. Hear if results be published, or will it be discretionary to companies themselves? What was “value added” for the companies the participated in the pilot program.

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Event Overview:

FDA has begun championing Quality Management Maturity (QMM), a new quality surveillance initiative intended to raise awareness at all levels of management in the pharmaceutical industry as to how to best achieve quality objectives and improve manufacturing site quality and supply chain reliability in drug manufacturing processes. QMM follows a maturity modeling paradigm. According to FDA, QMM is the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. 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

Join the webinar to learn what QMM is, and how far beyond GMP functions QMM will drill into.

Key Learning Objectives:

Learn about QMM’s 4 pillars:

• Compliance management: ability to consistently meet and/or exceed compliance with applicable laws, regulations, and industry best practices
• Risk management: ability to identify and manage organizational risks and build resilience
• Quality culture: ability to develop and maintain an organizational mindset and behaviors that value continuous learning and improvement, and customer satisfaction
• Sustainability: ability to successfully secure and manage appropriate technology, infrastructure, human capital, suppliers, customers, institutional knowledge, and other resources to sustain the operations.

Speakers:

Somnath Mishra
President
Shabas Solutions LLC

Mr. Somnath Mishra, MS, President at Shabas Solutions LLC, is a management consultant with 30+ years’ experience in academic research institute and global consulting firms, providing CIO and CFO advisory services to academic, state, federal government organizations, and Fortune 100 firms. Currently he oversees multiple public health related engagements with federal organizations at Shabas including those related to drug discovery and development, medical logistics, and COVID-19 Vaccine/Therapeutics Development. He led the FDA QMM Foreign API Manufacturer Pilot project including the design, development, and administration of the draft QMM Assessment tool.

William Hauck
Senior Associate
Shabas Solutions LLC

Mr. William Hauck, MS, ASQ is currently a Senior Associate with Shabas Solutions LLC providing consulting services to government and private sector life science organizations. He has over 19 years’ experience in the pharmaceutical/biotech industries serving in various roles in manufacturing, quality control, and quality assurance for both large and small sized companies. He has a broad and diverse background, with a focus on Quality Management System development, Risk Management, and Continual Improvement.

Clyde Schultz
Senior Associate
Shabas Solutions LLC

Dr. Clyde Schultz, Ph. D. Microbiology, University of Maryland, currently a Senior Associate with Shabas Solutions LLC. More than 40 years working in the Government, Academia, and Industry. Patent holder with 100 publications.

Zachary Royal
Senior Consultant
Shabas Solutions LLC

Mr. Zachary Royal, BS, is a Senior Consultant for Shabas Solutions LLC, specializing in data analytics and pharmaceutical logistics. He is an advocate for using data-driven solutions to improve operational sustainability and quality culture. He is excited to help usher in a new chapter of global quality excellence with Quality Management Maturity (QMM).

Robert J Michalik
Advisor, Quality & Corporate
Compliance
Shabas Solutions LLC

Mr. Robert Michalik, JD, RAC is an Advisor (Quality and Corporate Compliance) at Shabas Solutions LLC. He is a seasoned regulatory professional offering scientific, regulatory, quality, and legal consulting services to FDA-regulated companies. He has more than 30 years of experience in the biopharmaceutical, cell & gene therapy, and medical device industries, including 10 years’ experience in biotechnology as a R&D protein chemist. For the past 20 years, he has been focused exclusively in areas of biopharmaceutical & medical device product development, regulatory project management and pre- & post marketing compliance.

Register Free: https://globalmeet.webcasts.com/starthere.jsp?ei=1587812&tp_key=75697412c7

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