Quality Management Maturity Program – What’s New and How to Implement
4:00 PM – 5:30 PM, Central European Time (CET)
10:00 AM – 11:30 AM, Eastern Time (ET)
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Overview
FDA describes Quality Management Maturity (QMM) as the state attained when drug manufacturers have consistent, reliable, and robust business processes to achieve quality objectives and promote continual improvement.
FDA has promoted this concept for them to better apply their resources toward inspecting and monitoring GMP manufacturers that may have a higher risk of failures that could lead to product recalls and shortages.
Many manufacturers face the challenge of implementing the appropriate quality management and monitoring systems to ensure that their GMP business processes are consistent, reliable, and robust and can reduce the likelihood of product failure.
Join this webinar to learn about QMM and the FDA’s expectations on assessing the maturity of your Quality Management System based on objective metrics, as described by the FDA in their guidance, presentations, and workshops.
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Who Should Attend:
QA Management and associates, Heads of GMP Quality, GMP Manufacturing Management, Regulatory Inspection Hosting leads.
- Skill Level: Novice, Intermediate
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Special event information:
All attendees will receive a free certificate of attendance courtesy of our event partner Qualio.
Speaker
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Amnon EylathQuality Leader | GMP ExpertAmnon is a seasoned Quality Leader, experienced in the complete life cycle of Biological and Small Molecule drug development: from discovery, through nonclinical and Tox studies, clinical trials, process and method development, GMP manufacturing, validation, regulatory submissions and US/EU/MHRA commercial product approvals.
Amnon has a direct experience with Cell and Gene therapy and with developing and troubleshooting aseptic processes, including design and fabrication of isolators and the implementation and validation of highly effective decontamination and sterilization technology.
He has worked at various capacities in international companies, such as Amgen, Ely Lilly and GenzymeSanofi, as well as at cell therapy companies such as Cellcore Therapies, Histogenics and Minovia Therapeutics. Currently, Head of Quality at Alkeus Pharmaceuticals, responsible for building and leading all GXP Quality Management Systems 9GLP, GMP, GCP, etc.) and GXP compliance oversight. Support of regulatory submissions. Preparation and hosting of health authority inspections.
Amnon is also a volunteer with the PDA (Parenteral Drug Association), Chair for the drafting of Technica Report T-56 (Application of Phase-Appropriate Quality System and cGMP) and co-author for TR-65 Technology Transfer), Prior President of the New England Chapter of the PDA.
Partner
Qualio
Website
https://qualio.com/Founded in 2012, Qualio is the first cloud quality management software for all Life Sciences companies. Medical device and pharmaceutical companies need a secure and scalable quality management system with the flexibility to support their evolving needs. Qualio meets that challenge by cutting through the complexity to optimize and automate critical quality processes. The remote-first, Qualio team is distributed across North America and Europe.
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