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  • Medical Device Validation Training for Professionals

    18 - 20 October 2017

    Berlin, Germany

    Medical Device Validation Training for Professionals 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 [] info@cfpie.com The Center for Professional Innovation & Education Medical DeviceRegulatory AffairsQuality Assurance & ControlCompliance Engineering 20 workshops_and_courses [] Process ValidationRiskvalidation planscombination productsMedical Device
  • Medical Device Validation Training for Professionals

    18 - 20 October 2017

    Berlin, Germany

    Medical Device Validation Training for Professionals https://tess.elixir-europe.org/events/medical-device-validation-training-for-professionals-59a3279d-a054-43b1-af46-f7d93e708dc7 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 Attendees are encouraged to bring examples of Process Validation issues/concerns that they would like to reviewed and discussed during the course. 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 [] info@cfpie.com The Center for Professional Innovation & Education Regulatory AffairsQuality Assurance & ControlProcess DevelopmentAuditing & Compliance Engineering 20 workshops_and_courses first_come_first_served Process Validationproduct safetyMedical DeviceCFR 820ISO 13485
  • ELIXIR Software Carpentry - Ljubljana

    16 - 17 May 2019

    Ljubljana, Slovenia

    Elixir node event
    ELIXIR Software Carpentry - Ljubljana https://tess.elixir-europe.org/events/elixir-software-carpentry-ljubljana **ELIXIR Software Carpentry - Ljubljana** **16-17 May 2019, Faculty of Medicine,** **Vrazov trg 2, Ljubljana (Slovenia)** ELIXIR Software Carpentry is a workshop intended for all those who would like to learn more about the basics of R - software environment used in bioinformatics for statistical computing and graphics. The workshop will include a keynote lecture about data management in ELIXIR-SI. The workshop will be in English. The course will take place in the computer classroom at the Institute of Biostatistics and Medical Informatics (IBMI), Faculty of Medicine, Vrazov trg 2, Ljubljana. **The course is free of charge. The limit of participants is 20.** If the number of registered applicants exceeds this limit, selection of participants will be made. It will be based on the time of their registration and their affiliations, as well as geographic distribution. Sessions will be intensive and hands-on, and taught by experienced software carpentry instructors. The course is recommended for anyone who would like to learn more about using statistical computing and graphics in the bioinformatics field, both for research or operational work. **Program topics:** - Keynote lecture about ELIXIR-SI data management - Introduction to Linux/Unix command line - Git - R **The course is organised by ELIXIR Slovenia in collaboration with Data & Software Carpentry.** More info about the course is available on the **[ELIXIR-SI eLearning Platform (EeLP)](https://elixir.mf.uni-lj.si/course/view.php?id=46)**. 2019-05-16 09:00:00 UTC 2019-05-17 16:00:00 UTC ELIXIR Slovenia, University of Ljubljana, Faculty of Medicine University of Ljubljana, Faculty of Medicine, Vrazov trg 2, SI-1000 Ljubljana, Slovenia, Ljubljana, Slovenia University of Ljubljana, Faculty of Medicine, Vrazov trg 2, SI-1000 Ljubljana, Slovenia Ljubljana Central Slovenia Slovenia SI-1000 Statistics and probability Data management Computer science University of Ljubljana, Faculty of Medicine elixir@mf.uni-lj.si Data & Software Carpentry Life Science ResearchersBeginners in statisticsPhD studentsMaster students 20 workshops_and_courses registration_of_interest EeLPeLearningStatistics R-programmingSoftware Carpentry
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