Integration of Risk Management Principles and Activities into the Quality System
16 - 17 October 2017
Berlin, GermanyIntegration of Risk Management Principles and Activities into the Quality System https://www.cfpie.com/Custom/Catalog.aspx?C=22&L=4&D=0 https://tess.elixir-europe.org/events/integration-of-risk-management-principles-and-activities-into-the-quality-system The regulatory and business requirements for the pharma, diagnostics, and medical-device fields continue to update, blend, overlap, and blur. With these changes, the importance of risk assessment—and risk management—gains higher business and regulatory significance. It now becomes even more important for professionals in these fields to recognize, accept, understand, and respond to these changes —particularly since new regulatory requirements have emerged within this changing environment. The market’s Tolerance for Failure of Drugs, Devices, and IVDs has reduced significantly in recent decades. This reduction reflects a general loss of confidence in the medical industry. The adoption of formal Quality Management Systems (QMS) has recovered some of that confidence, but we must still do more. This course addresses what we can do. 2017-10-16 09:00:00 UTC 2017-10-17 17:00:00 UTC The Center for Professional Innovation & Education The Berlin Hilton, Berlin, Germany The Berlin Hilton Berlin Germany  email@example.com The Center for Professional Innovation & Education quality/production managersengineersauditorsregulatory/quality professionalsclinical/product specialists R&D engineerslaboratory professionalsproduct-development professionals 20 workshops_and_courses first_come_first_served diagnosticsPharmaceuticalMedical DeviceBiotech
Medical Device Validation Training for Professionals
18 - 20 October 2017
Berlin, GermanyMedical Device Validation Training for Professionals https://www.cfpie.com/ProductDetails.aspx?ProductID=261 https://tess.elixir-europe.org/events/medical-device-validation-training-for-professionals Participants will learn how an effective Process Validation system is a critical requirement to the movement toward a risk-based approach to compliance and product safety. Also to be discussed is how to tackle process validation for medical device combination products. Issues to be covered include: •Learn how poor validation procedures and practices can lead to regulatory actions from regulators •Assurance of product quality derived from a compliant validation program •Learn how to improve process system knowledge and understanding •Learn methods for developing process validations and best practices •Understand the scope of regulations governing process validation and identify gaps •Develop a plan to rectify existing validation plans, protocols and reports •Learn how to implement and deploy a master validation plan 2017-10-18 09:00:00 UTC 2017-10-20 15:00:00 UTC The Center for Professional Innovation & Education The Berlin Hilton, Berlin, Germany The Berlin Hilton Berlin Germany  firstname.lastname@example.org The Center for Professional Innovation & Education Medical DeviceRegulatory AffairsQuality Assurance & ControlCompliance Engineering 20 workshops_and_courses  Process ValidationRiskvalidation planscombination productsMedical Device
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