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  • Integration of Risk Management Principles and Activities into the Quality System

    16 - 17 October 2017

    Berlin, Germany

    Integration of Risk Management Principles and Activities into the Quality System 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 [] info@cfpie.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
  • Water Purification Systems for Regulated Industries

    23 - 24 October 2017

    Berlin, Germany

    Water Purification Systems for Regulated Industries https://tess.elixir-europe.org/events/water-purification-systems-for-regulated-industries The course consists of interactive lectures, discussions, and imbedded exercises. Participants will also be placed in several real life situations where they complete a compliance review of a schematic process flow diagram, analyze failures using trend reports, critique a risk assessment, and perform a change control analysis including the impact of requested or proposed modifications. The course is designed to provide the attendee with a practical understanding of the following topics: •Basic water chemistry •Water quality selection criteria •EPA, EU, and WHO drinking water standards •The governing regulatory agencies with direct impact on water systems •Analytical water grades (1, 2, 3) and reagent water types (I, II, III, IV, with A, B & C subgroups) •Pharmacopeia water grades (Purified, Highly Purified, Water for Injection & Clean Steam) •Pretreatment component equipment - selection and operating principals •Final treatment options (reverse osmosis, vapor compression, single-effect and multiple-effect stills) •Opportunities for energy and water resource conservation •Point of use criteria such as temperature, location, time-of-day, and demand (GPM & GPD) •System design including materials of construction, generation, storage and distribution options •Trend reports (analysis, problem identification, predictive value) •Control systems, data historian, secure access, set points and alarms •Managing performance deviations and component failure •Direct and in-direct impact analysis •Quality by design including risk assessment •Instrument calibration for critical, non-critical, and informational only devices •Maintenance impacts to system performance, reliability, and validation •The importance of as-built documentation - user and field directed changes 2017-10-23 09:00:00 UTC 2017-10-24 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 Regulatory AffairsQualityComplianceR&DValidationManufacturingMaintenanceEngineering 20 workshops_and_courses first_come_first_served water chemistryWater quality water systemsSystem design Pharmacopeia water grades Control systemsInstrument calibration
  • Beacon - 2018 AHM Workshop

    7 June 2018

    Berlin, Germany

    Elixir node event
    Beacon - 2018 AHM Workshop https://tess.elixir-europe.org/events/beacon-2018-ahm-workshop ELIXIR workshop "Beacon", Jun 7 2018 at the ELIXIR AHM 2018, Berlin, Germany 2018-06-07 09:00:00 UTC 2018-06-07 13:00:00 UTC ELIXIR Germany and Beacon community Hotel Berlin Berlin, 17, Lützowplatz, Berlin, Germany Hotel Berlin Berlin, 17, Lützowplatz Berlin Berlin Germany Genomics Hotel Berlin Berlin [] life scientistsResearchers 30 workshops_and_courses registration_of_interest genomicsdata managementeLearningEeLP
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