Learn how GDP changes will affect your operations This 1-hour webinar provides an overview of the regulations related to Good Distribution Practice, environmental mapping qualification, and software validation. With the revisions to EU GMP Annex 15, all stakeholders must control the critical aspects of their operations through qualification and validation throughout a product’s lifecycle. Because of globalization of manufacturing new GDP-compliant warehouses are needed around the world. All entities in the supply chain must show that temperature-sensitive products are being stored and transported appropriately. This webinar will familiarize you with: Temperature mapping qualification of storage areas Using mapping studies to determine sensor location Creating a monitoring plan (if it is worth mapping, it is worth monitoring) Validation of environmental monitoring system software How to apply a GAMP-based risk assessment framework to ensure compliance and product quality You will be interested in this webinar if you store or distribute products in GxP regulated areas and want to learn how to ensure your environmental mapping qualification and monitoring systems are compliant with the changes to Annex 15. Key Learning Objectives Short overview of changes to regulations and guidance related to mapping and validation of the computerized systems Five simple rules for mapping sensor placement in warehouses Understand why monitoring systems are needed and what is required to validate a system Use a GAMP-based Risk Assessment Framework Audience Facility & Operations Managers Quality Assurance/Quality Control Logistics & Distribution Managers Regulatory Compliance Laboratory Managers Validation/Qualification professionals Email Address*First Name*Last Name*Your Interest Area*-- Please Select --AgrometeorologyAirplane Weather SafetyAirport WeatherAmbient or High Humidity ProcessesAtmospheric and Meteorological ResearchAutomotive Manufacturing ProcessesBallistic, Naval and Tactical WeatherBiogas ProductionBio-Decontamination ProcessesCompressed AirConcrete and ConstructionFood and Beverage ProcessesGas Turbines and Combustion EnginesGreenhouses and Indoor AgricultureHVAC & Indoor Air QualityHydrologyIndustrial Research Laboratories and FacilitiesLife Science Laboratories and FacilitiesLife Science EquipmentLiquid ConcentrationLow Humidity Processes (under 10% RH)Lubrication and Hydraulic SystemsMuseums, Archives and LibrariesOff-Shore and Ship Weather MeasurementOn-Shore Harbour WeatherOperational Weather Observations and ForecastingOther Industrial MeasurementOther Weather or Environmental MeasurementOutdoor Air QualityPower TransmissionRail WeatherRenewable Weather Energy DevelopmentRenewable Weather Energy OperationRoad WeatherUrban MeteorologyWarehouses and Cargo ContainersWind Turbine ManufacturingCompany*TitleBusiness PhoneCountry*--Please Select--United StatesUnited KingdomCanadaChinaIndiaJapanAustraliaBrazilFranceGermanyFinland--------------AfghanistanÅland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBrit/Indian Ocean Terr.Brunei DarussalamBulgariaBurkina FasoBurundiCambodiaCameroonCanadaCape VerdeCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCongo, The Dem. 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Speaker Piritta Maunu Life Science Regulatory Compliance and Industry Expert Piritta Maunu has 15 years of experience in biotechnology, having worked in several quality management positions. Maunu holds a degree of M.Sc. (Cell Biology) and is certified to teach with a specialty in General Biology, both degrees from the University of Jyväskylä, Finland. In her role at Vaisala, she supports the sales department, assists the quality department with audits, creates educational content for life science customers, and provides application support to R&D teams creating solutions for monitoring critical environments.
Piritta Maunu Life Science Regulatory Compliance and Industry Expert Piritta Maunu has 15 years of experience in biotechnology, having worked in several quality management positions. Maunu holds a degree of M.Sc. (Cell Biology) and is certified to teach with a specialty in General Biology, both degrees from the University of Jyväskylä, Finland. In her role at Vaisala, she supports the sales department, assists the quality department with audits, creates educational content for life science customers, and provides application support to R&D teams creating solutions for monitoring critical environments.
