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3 events found

City: Bogota  or Athens  or Tarragona  or Berlin  or Oeiras  or Ljubljana 

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Keywords: ISO 13485  or CE Marking  or validation plans 

  • Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications

    12 - 13 October 2017

    Berlin, Germany

    Medical Devices: EU Directives, Guidance, CE Marking and ISO Standard Certifications https://tess.elixir-europe.org/events/medical-devices-eu-directives-guidance-ce-marking-and-iso-standard-certifications Things are changing for Medical Devices and IVDs in the European Union (EU): new fundamental standards, new EU device regulations and BREXIT. What is now needed to enter or, more importantly, to maintain presence in this attractive marketplace for medical devices? Satisfying requirements harmonized across the 28 member states should be a straightforward process to get products approved for distribution in each country - but is it? This course identifies and explains the requirements – old and new – for medical devices, the steps to obtain entry into the marketplace (including setting up on-going procedures and relationships), the increasing importance of Clinical Evaluation and Post Market surveillance, Notified Bodies and Competent Authorities. The course also shares some lessons learned from the Course Director, who has over 25 years of experience with CE marking medical devices for distribution in the EU. 2017-10-12 09:00:00 UTC 2017-10-13 17:00:00 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 Device 20 workshops_and_courses first_come_first_served EU DirectivesGuidanceCE MarkingISO Standard
  • 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
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