Quality Management Maturity Program – What’s New and How to Implement
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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.
Who Should Attend:
QA Management and associates, Heads of GMP Quality, GMP Manufacturing Management, Regulatory Inspection Hosting leads.
- Skill Level: Novice, Intermediate
Special event information:
All attendees will receive a free certificate of attendance courtesy of our event partner Qualio.
Amnon EylathQuality Leader | GMP Expert
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.
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.
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, Global Vice President of Quality at Minovia Therapeutics, working out of the Massachusetts site and developing quality systems and implementation of continuous mprovement methods to the development of clinical cell therapy processes.
Active 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.
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