Quality Management Maturity (QMM) and Drug Supplies
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Speaker : BINH T. NGUYEN
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When : Friday, November 15, 2024
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Time : 01 : 00 PM EST
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Binh T. Nguyen, Pharm.D., M.S. Reg Sci, BCSCP, FHPE is an independent biopharmaceutical expert with over 22 years of experience in biopharmaceuticals (injectables, oral dosage, topical, liquid, transdermal, & inhalers), biologics/biosimilars, compounding pharmacies, positron emission tomography, dietary supplements, combination products, compliance, pre-approval, and application assessment while at the US FDA. He has extensive experience sterile compounding, airflow, insanitary conditions and sterility assurance, stability and beyond use dating (BUD), investigations and CAPAs, supplier and contract qualification and management, and media fills. Nguyen has served as a subject matter expert in drug regulation interpretation pertaining to and impact on drug quality, manufacturing, and control worldwide. He has expertise in training, mentoring, coaching, and auditing drug specialists internationally. He received the FDA Commissioner’s Special Citation and numerous other high-level FDA Recognition Awards. He’s developing an inspection software to conduct self-audit using FDA and other regulatory bodies’ regulations with artificial intelligence to empower auditors.
Per 2024-01423.pdf (govinfo.gov), QMM refers to the extent to which drug manufacturing establishments implement quality management practices that prioritize patients, drive continual improvement, and enhance supply chain reliability through the strategic integration of business decisions and manufacturing operations with quality practices and technological advancements. As part of the QMM program initiative, CDER is developing a QMM Assessment Tool (including both a protocol and rubric) to evaluate how effectively establishments monitor and manage quality and quality systems.
OPQ White Paper for Quality management Maturity (fda.gov) defines QMM is the state attained by having consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement. Mature quality management ensures not only that quality product is on the market now, but that quality issues will not keep a product from being available to patients and consumers in the future.
In order to get to QMM, the foundation has to be solid CGMP. Speaker introducing CGMP ratings of quality systems aligning with ICH Q10 model to achieve QMM.
Areas Covered
- Define Quality Management Maturit
- Understand rating system of QMM by FDA
- Explore Quality Systems and how rating of quality systems can achieve QMM
Who Should Attend
Everyone involved in producing quality drug products
Why Should You Attend
Be part of providing quality solutions by learning about QMM and how your companies can optimize manufacturing process performance and product quality therefore enhancing supply chain reliability and foster proactive continual improvement.
The QMM program aims to encourage drug manufacturers to implement quality management practices that go beyond current good manufacturing practice (CGMP) requirements. The goals of this program are fourfold:
- Foster a strong quality culture mindset
- Recognize establishments that have advanced quality management practices and acknowledge establishments that strive to continually improve quality management practices
- Identify areas where quality management practices can be enhanced and provide suggestions for growth opportunities
- Minimize risks to product availability to assure reliable market supply
Topic Background
Drug shortages continue to be an everyday problem that FDA and industry have to face with leading to risks to the health of patients and consumers. In fact, US Congress had questioned FDA of the chemotherapy drug shortages in recent years resulting in many patients not getting chemotherapy treatments they so desperately needed.
As a result, FDA CDER has established a program to promote quality management maturity (QMM) at drug manufacturers to hopefully foster a more robust drug supply chain and greater commitment to quality in pharmaceutical manufacturing.
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$160.00
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