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3 events found

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

and

Keywords: ISO 13485  or Biotechnology 

  • Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products

    12 - 13 October 2012

    Berlin, Germany

    Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Products https://tess.elixir-europe.org/events/comprehensive-overview-of-fda-regulatory-compliance-for-drug-and-biotech-products 2012-10-12 00:00:00 UTC 2012-10-13 00:00:00 UTC The Center for Professional Innovation & Education The Berlin Hilton, Berlin, Germany The Berlin Hilton Berlin Germany [] [] [] workshops_and_courses [] Biotechnology
  • Good Manufacturing Practices

    13 - 15 November 2013

    Berlin, Germany

    Good Manufacturing Practices https://tess.elixir-europe.org/events/good-manufacturing-practices 2013-11-13 00:00:00 UTC 2013-11-15 00:00:00 UTC The Center for Professional Innovation & Education The Burlington Hotel, Berlin, Germany The Burlington Hotel Berlin Germany Pharmacology [] [] [] workshops_and_courses [] Biotechnology
  • 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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