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X-WR-CALDESC:Events for Novatek International
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DTSTART:20210101T000000
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DTSTART;VALUE=DATE:20220614
DTEND;VALUE=DATE:20220616
DTSTAMP:20260419T151328
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SUMMARY:SPEAKER: Aseptic Manufacturing – Maintaining the Validated State | Copenhagen\, Denmark
DESCRIPTION:This two-day intensive summit brings together the industry leaders in compliance\, aseptic manufacturing and maintaining the validated state. The conference will go beyond presentations on best practice and consists of both presentations and workshops on different aspects of aseptic manufacturing. Attendees will therefore gain a deeper understanding of the new messages from the new Annex 1 draft\, FDA focuses on inspecting sterile facilities\, sterilisation\, process validation\, life cycle approach and more. The conference will showcase some of the tech that impacts aseptic manufacturing. \nIn addition to the many presentations and workshops\, the conference will also provide many opportunities for networking. Read more about the individual presentations in the full agenda. \nThe conference will be a hybrid event\, and this enables attendees to either view online or be physically present at the event. We believe this is optimal for our customers in the current climate and hope you will attend. \nConference outline\nDownload the full agenda with speaker presentations (updated 21 July 2021) → \nDay 1\, November 15th\nModerator: Laurence O’Leary\, ValidEire Aps \n\nIntro to Day 1 by Moderator\nEU Annex 1- Manufacture of Sterile Medicinal Products\nPierre Devaux\, Theraxel\nSystem Real Time Data Integrity\, Electronic Sample Collection in Controlled Areas.\nSusan Cleary\, Novatek International\nPlenary Q&A\nValidation of Lyophilisation for Parenterals\nKirstie Goggin\, MTL projects\nEquipment and Facility design of an Aseptic Facility\nRobert J. Hayes\, SeerPharma (UK)\nCleanroom and Contamination Control Strategy\nPierre Devaux\, Theraxel\nPlenary Q&A / Wrap up\nSnack and refreshments\nComplimentary of Novatek International\n\nDay 2\, November 16th\nModerator: Pierre Devaux\, Theraxel \n\nIntro to Day 2 by Moderator\nMedia Fill studies\nGavin Ross\, Founder\, GTR Pharma\nAseptic training with VR\nSebastian Scheler\, CEO & Lead Psychologist\, Innerspace\nPlenary Q&A\nAnnex 1 & Environmental monitoring\nMatt Kite\, Lighthouse Worldwide Solutions\nTemperature Mapping – Validation and Temperature Measurement\nEnrique Riis\, Ellab\nProcessing and transfer of primary packaging material for sterile production and transfer to the filling line\nJana-Cathrien Müller\, Atec Steritec GmbH\nPlenary Q&A / Wrap-up\n\nConference objectives\nThe objective of this conference is to provide participants with practical knowledge and understanding of regulatory requirements and techniques that can be put to use in their own aseptic manufacturing process strategy. The presenters will focus on the newest information available and will cover a wide range of subjects relevant to aseptic manufacturing and maintaining the validated stateThe objective of this conference is to provide participants with practical knowledge and understanding of regulatory requirements and techniques that can be put to use in their own aseptic manufacturing process strategy. The presenters will focus on the newest information available and will cover a wide range of subjects relevant to aseptic manufacturing and maintaining the validated state. \nWho should attend\nThe conference is primarily relevant for R&D staff\, Production Leaders\, Supporters\, Commissioning\, Qualification and Validation teams and Quality Assurance seeking the latest knowledge about risk- and cross contamination control\, as well as engineering companies wanting to learn more about the viewpoint of the pharmaceutical industry and exchanging experiences
URL:https://ntint.com/event/speaker-aseptic-manufacturing-maintaining-the-validated-state-key2compliance/
LOCATION:DGI Byen\, Copenhagen
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
ORGANIZER;CN="ValidEire Consulting":MAILTO:info@valideire.com
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