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DTSTART;VALUE=DATE:20240910
DTEND;VALUE=DATE:20240912
DTSTAMP:20240619T083113Z
CREATED:20240322T075058Z
LAST-MODIFIED:20240619T083113Z
UID:6699-1725926400-1726099199@valideire.com
SUMMARY:CIP\, SIP & EM
DESCRIPTION:10th-11th September 2024: Cleaning in Place (CIP)\, Sterilisation in Place (SIP)\, and Environmental Monitoring (EM)\nLocation: Park Bio\, Østerbro\, Østerbrogade 79\, 2100 København Ø\, Denmark.\nPrice: € 1.395\,- DKK 9.995\,-\nEarly Bird: Get 15% off before June 15th. \nLive streaming option: € 495\,- DKK 3.399\,- If you don’t have the possibility to join us physically in Copenhagen\, we offer an online option where you can join sessions and Q&As via live video.  \n\n\nRegister & Pay\n\n \nSUMMIT DESCRIPTION\nThe summit model is built on bringing expert speakers to one event and matching their speeches with contemporary challenges and opportunities within Life Sciences. Furthermore it provides an opportunity to engage with highly specialised employees from other companies working specifically with these disciplines. Lastly it will provide with a network\, that can be a door opener with multiple synergies both for employees\, companies and service providers. \nThis summit will convene industry leaders to explore critical aspects of Life Sciences regulatory requirements and operations. Discussions will revolve around refining strategies\, validating procedures\, and investigating innovations including inspiration on sustainability and digitalisation. Emphasis will be placed on the pivotal role of monitoring in preventing contamination\, alongside strategies for effective implementation. Regulatory compliance\, particularly adherence to Good Manufacturing Practices (GMP)\, will be highlighted\, with a focus on quality assurance measures and documentation. \n  \nAttendees will benefit from work shops\, case studies and shared experiences\, fostering a culture of continuous improvement. Moreover\, updates on Annex 1 of the pharmaceutical industry’s regulatory guidelines and applying these in a role as QP will be provided\, offering insights into the latest standards and expectations. \nThe summit will serve as a nexus for collaboration\, equipping participants with the latest advancements and best practices to elevate product safety and regulatory standards within the pharmaceutical landscape. \nWHO IS THE SUMMIT RELEVANT FOR? \nWhether you or your team works with quality assurance\, quality control\, development\, validation or production related to Cleaning Sterilisation processes\, or Environmental Monitoring\, this summit will add value to your team in multiple ways. \nINTERESTED IN NETWORKING? \nWhether you are interested in meeting people working with the similar disciplines under focus\, companies providing solutions or just building your professional network\, we have thought of this. \nThere will be an exclusive networking arrangement on the first evening of the event at Madklubben in Copenhagen. Here you can eat and drink at one of the most contemporary favourite dining locations besides the event venue. Note\, this is an add-on so if you do not wish to participate\, you can just join us at the summit. Learn more when you check out in your basket. \n\nAGENDA\n\n\n\nDay 1 – 10th September\, 2024\nDay 2 – 11th September\, 2024\n\n\n\n\n\n\n08:45-09:15\nBreakfast & Networking\n08:45-09:15\nBreakfast & Networking\n\n\n\n\n\n\n09:15-09:30\nIntro by Moderator\n09:15-09:30\nIntro to day 2 by Moderator\n\n\n\n\n\n\n09:30- 10:15\nWalid EL Azab\, QP Pro Services\nRole of the Qualified Person in Managing Changes to CIP\, SIP\, and EM Processes in Pharmaceutical Manufacturing\n09:30- 10:15\nRichard Hall Hall\, Rattiinox S.r.l\nClean by Design\n\n\n\n\n\n\n10:15-10:45\nNetworking break / Coffee & Tea\n10:15-10:45\nNetworking break / Coffee & Tea\n\n\n\n\n\n\n10:45-11:30\nKenneth Farrugia\, Mint Health\nEnvironmental Monitoring strategy\n10:45-11:30\nEnrique Riis\, Ellab\nEnvironmental Monitoring in Operations\n\n\n\n\n\n\n11:30 -12:30\nLunch\n11:30 -12:30\nLunch\n\n\n\n\n\n\n12:30-13:15\nJohn Byrne\, Hyde Engineering + Consulting  \nDesigning and Remediating CIP Processes for Sustainable Cleaning\n12:30-13:30\nKenneth Farrugia\, Mint Health \nVisual Inspection Workshop Cleaning\n\n\n\n\n\n\n13:15-14:00\nJuha Mattila\, Steris\nDevelopments in Terminal Sterilisation\n13:30 -14:00\nAll available speakers \nPlenary Q&A\n\n\n\n\n\n\n14:00-14:30\nNetworking break / Coffee & Tea\n14:00\nModerator – Wrap-up\n\n\n\n\n\n\n14:30-15:15\nNiels Skou\, Lyras A/S\nSustainable UV Technology\n\n\n\n\n\n\n17:30- 20:30\nNetworking dinner at Madklubben\, Østerbrogade 79\, 1.sal\, 2100 København Ø\, Denmark (price 795 dkk)\n\n\n\n\nSPEAKERS – TOPICS\n\n\n\nSpeaker\nTopic\n\n\n\n\n\n\n \nWalid EL Azab\nCo-Founder & Managing Director\nQP Pro Services\nRole of the Qualified Person in Managing Changes to CIP\, SIP\, and EM Processes in Pharmaceutical Manufacturing\n\n\n\n  \n\n\n\n \nJuha Mattila\nSenior Manager Technical Services\nSteris\nDevelopments in Terminal Sterilisation\n\n\n\n\n\n\n \nKenneth Farrugia\nOperations Manager\, OpEx Lead\nMint Health\nWorkshop:\nVisual Inspection Qualification\n\n\n\n\n\n\n \nNiels Skou\nLyras A/S\nSustainable UV Technology\n\n\n\n\n\n\n \nJohn Byrne\nAssociate Director\, Technical Services Europe\nHyde Engineering + Consulting\nDesigning and Remediating CIP Processes for Sustainable Cleaning\n\n\n\n\n\n\n \nRichard Hall Hall\nRattiinox S.r.l.\n\nClean by Design\n\n\n\n\n\n\n \nEnrique Riis \nManaging Director\nEllab\nEM in Operations\n\n\n\n\n\n\n \nLaurence O’Leary \nOwner\nValidEire Aps\nModerator\n\n\n\n\nSPONSORS \n\n\n\n\n\n\n\n\nARRANGED BY \n \n\n\nRegister & Pay
URL:https://valideire.com/event/cip-sip-em/
LOCATION:Park Bio\, ØSTERBROGADE 79\, Copenhagen\, 2100\, Denmark
ATTACH;FMTTYPE=image/png:https://valideire.com/wp-content/uploads/2024/04/Diversebannere5-600x450-1.png
ORGANIZER;CN="Valideire Aps":MAILTO:info@valideire.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Copenhagen:20230425T093000
DTEND;TZID=Europe/Copenhagen:20230426T170000
DTSTAMP:20240417T061455Z
CREATED:20240305T115700Z
LAST-MODIFIED:20240417T061455Z
UID:6533-1682415000-1682528400@valideire.com
SUMMARY:Cleaning Sterilisation Processes
DESCRIPTION:25th-26th April 2023 at DGI Byen Conference Center\, Copenhagen\nA collaboration between ValidEire ApS and Key2Compliance \n  \nSUMMIT DESCRIPTION\nCleaning and Sterilization processes related to production equipment need to meet the standards of the authorities where the control and reduction of chemical\, microbial\, particulate and endotoxin/pyrogen contamination is  considered important. Any contamination control strategy requires an evaluation of these controls based on risk and risk assessment. \nWhether you work with Pharmaceuticals or Medical Devices\, you are witness to a raised focus in respect to Cleaning and Sterilization processes. This 2-day summit in Copenhagen\, Denmark brings Cleaning and Sterilization processes to you  with multiple expert competences\, including Quality Assurance experts\, Global Task Force Standard contributors\, and high-level consultants. And on top of this\, you will have the opportunity to link up and network with industry peers. \nWHO IS THE SUMMIT RELEVANT FOR? \nWhether you or your team works with Quality Assurance\, Quality Control\, development\, Validation or production related to Cleaning and Sterilization processes\, this summit will add value to your team in multiple ways: You could work as eg. Manager\, Chemist\, Production Supporter\, QC\, RA\, … \n  \nAGENDA \n\n\n\nDay 1 – 25th April\, 2023\nDay 2 – 26th April\, 2023\n\n\n\n\n\n\n09:30-10:15 Laurent Merli\nWhy a robust cleaning process before is essential for the success of the Sterilization one?\n09:00-09:45 Joe Cagnassola\nCreating a robust Cleaning Protocol and Report\n\n\n\n\n\n\n10:15-11:00 Susan B. Cleary\nRisk-Based Cleaning Validation\, Carry Over and Process Automation\n09:45-10:30 Mark Thompson\nTop 10 inspection findings associated with Sterilization and Depyrogenation Processes\n\n\n\n\n\n\n11:00-11:30 Coffee\, tea and snacks\nExibition open\n10:30-11:00 Coffee\, tea and snacks\nExibition open\n\n\n\n\n\n\n11:30-12:15 Kenneth Farrugia\nSustainable Cleaning Validation\n11:00-11:45 Igor Gorsky\nUse of statistics including treatment of censored data in Lifecycle Cleaning Validation as prescribed by ASTM E3106\n\n\n\n\n\n\n12:15-13:15 Lunch\n11:45-12:45 Lunch\n\n\n\n\n\n\n13:15-14:00 Walid El Azab\nCase studies on common cleaning mistakes and enablers for cleaning improvement\n12:45-13:30 Solenn Janvier\nDevelopment and validation of an analytical method for cleaning validation: Tips & Tricks\n\n\n\n\n\n\n14:00-14:30 Coffee\, tea and snacks\nExibition open\n13:30-14:15 Mark Thompson\nNew Product Development; Defining and justifying the approach to sterilization\n\n\n\n\n\n\n14:30-15:15 Mohammad Ovais\nMonitoring and trending of cleaning data\n14:15-14:45 Plenary Q&A\n\n\n\n\n\n\n15:15-16:00 Dr. Andreas Flückiger\nImproving quality of Health Based Exposure Limits (HBELs). Current best practices based on guidance by EMA\, PIC/S and ASTM Standard E-3219\n14:45 – Close-out\n\n\n\n\n\n\n16:00-17:30 Workshops\n\n\n\n\n  \nSPEAKERS\n\n\n\n \nKeynote Speaker\nMark Thompson\,\nManaging Director\,\nMTL Projects Ltd\n \nSpeaker\nLaurent Merli\nSterile Manufacturing & Nuclear\nMedicine Drug Expert chez\nTHERAXEL\n\n\n\n\n\n\n \nSpeaker\nIgor Gorsky\,\nPrincipal Process Validation Consultant\,\nValsource\n \nSpeaker\nMohammed Ovais\,\nPharmaceutical Consultant\n\n\n\n\n\n\n \nSpeaker\nIoanna-Maria Gerostathi\,\nQuality & Validation Professional\n \nSpeaker\nSolenn Brajeul Janvier\,\nRP Pierre Fabre Group\n\n\n\n\n\n\n \nSpeaker\nKenneth Farrugia\,\nOperations Manager\,\nMint Health Ltd\n \nSpeaker\nDr. Andreas Flückiger\,\nOccupational Toxicology and\nContainment in the\nPharmaceutical Industry\n\n\n\n\n\n\n \nSpeaker\nJoe Cagnassola\,\nAssociate Director Validation\,\nBoehringer-Ingelheim\n \nSpeaker \nSusan B. Cleary\,\nDirector of Product Development\,\nNovatek International\n\n\n\n\n\n\n \nSpeaker\nWalid El Azab\,\nIndustrial Pharmacist & Qualified Person\, Steris\n \nSpeaker\nTony Christiansen\,\nCEO / Owner of Scantago A/S\n\n\n\n\n\n\n \nSpeaker\nJuha Mattila\,\nDirector\, Sterlization Technologies at STERIS life Sciences Steris\n\n\n\n\n  \nSPONSORS\n \n  \n \n  \nARRANGED BY \n \n 
URL:https://valideire.com/event/cleaning_sterilisation-processes/
LOCATION:DGI Byen\, Denmark
ATTACH;FMTTYPE=image/jpeg:https://valideire.com/wp-content/uploads/2024/03/CS0423-e1710160053204.jpg
ORGANIZER;CN="Valideire Aps":MAILTO:info@valideire.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Copenhagen:20220614T090000
DTEND;TZID=Europe/Copenhagen:20220615T163000
DTSTAMP:20240417T061438Z
CREATED:20240305T115559Z
LAST-MODIFIED:20240417T061438Z
UID:6529-1655197200-1655310600@valideire.com
SUMMARY:Aseptic Manufacturing - Maintain Validated State
DESCRIPTION:14th-15th June 2022 at DGI Byen\, Copenhagen\nA collaboration between Key2Compliance and ValidEire ApS \n  \nSUMMIT DESCRIPTION\nThis 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 OBJECTIVE \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 state. The 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. \n  \nAGENDA\n\n\n\nDay 1 – 14th June\, 2022\nDay 2 – 15th June\, 2022\n\n\n08:45-09:20 Registration and breakfast\n08:45-09:20 Breakfast and networking\n\n\n09:20-09:30 Intro to Day1 by Moderator\n09:20-09:30 Intro to Day 2 by Moderator\n\n\n09:30-10:15 EU Annex 1 – Manufacture of Sterile Medicinal Products Pierre Devaux\, Theraxel\n09:30-10:15 Compliance Updates for Media Fill Validation John Y.Lee\n\n\n10:15-11:00 Trending and Pattern Recognition as part of a Contamination Control Strategy Susan Cleary\, Novatek International\n10:15-11:00 Aseptic training with VR Andreas Hablesreiter\, Innerspace\n\n\n11:00- 11:30 Plenary Q&A\n11:00-11:30 Plenary Q&A\n\n\n11:30-12:30 Lunch\n11:30-12:30 Lunch\n\n\n12:30-13:15 Validation of Lyophilisation for Parenterals Kirstie Goggin\, MTL Projects\n12:30-13:15 Annex 1 & Environmental monitoring Matt Kite\, Lighthouse Worldwide Solutions\n\n\n13:15-14:00 Equipment and Facility design of an Aseptic Facility Robert J. Hayes\, SeerPharma (UK)\n13:15-14:00 Temperature Mapping- Validation and Temperature Measurement Enrique Riis\, Ellab\n\n\n14:00-14:30 Break/ Coffee & Tea\n14:00-14:30 Networking break/ Coffee & Tea\n\n\n14:30-15:15 Cleanroom and Contamination Control Strategy\nPierre Devaux\, Theraxel\n14:30-15:30 Processing and transfer of primary packaging material for sterile production and transfer to the filling line Jana-Cathrien Müller\, Atec Steritec GmbH\n\n\n15:15-16:00 Plenary Q&A\n15:30-16:15 Plenary Q&A all Speakers\n\n\n16:00-16:15 Wrap-up\n16:15-16:25 Wrap-up by Moderator\n\n\n16:30-18:00 Snack and refreshments-complimentary of\n\n\n\n\nSPEAKERS \n\n\n\n \nJohn Y. Lee\,\nPharmaceutical Compliance Associates\n \nPierre Devaux\,\nTheraxel-Point Forty Five\n\n\n \nKirstie Goggin\,\nMTL Projects\n \nRobert J Hayes\nBSc\, CEng\, FIMechE\, FIET Director\, SeerPharma (UK)\n\n\n \nAndreas Hablesreiter\,\nSenior Pharma Expert Innerspace – The Deep Training Company\n \nMatt Kit\nLighthouse Worldwide Solutions\n\n\n \nSusan B. Cleary\, B.CS\, M.B.A.\nDirector of Product Development\,\nNovatek International.\n \nEnrique Riis\,\nEllab\n\n\n \nJana-Cathrien Müller\,\nAtec Steritec GmbH\n \nLars- Eric Ellow\,\nKey2Comnpliance\n\n\n\nSPONSORS\n \nARRANGED BY \n \n 
URL:https://valideire.com/event/aseptic-manufacturing-maintaining-the-validated-state/
LOCATION:DGI Byen\, Denmark
ATTACH;FMTTYPE=image/jpeg:https://valideire.com/wp-content/uploads/2024/03/Aseptic0622a-e1710160381174.jpg
ORGANIZER;CN="Valideire Aps":MAILTO:info@valideire.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Copenhagen:20210910T090000
DTEND;TZID=Europe/Copenhagen:20210910T150000
DTSTAMP:20240313T112605Z
CREATED:20240305T115758Z
LAST-MODIFIED:20240313T112605Z
UID:6536-1631264400-1631286000@valideire.com
SUMMARY:Process Validation Workshop
DESCRIPTION:10th September 2021\, Copenhagen \n  \nWORKSHOP DESCRIPTION\nSharing\, learning\, and networking in a robust network of Process Validation Specialists. \n  \nAGENDA\n09:00 – Breakfast \n09:30 – Intro \n09:40- Round the table \n09:45- Doing Digital or Being Digital – Marc Vordermann \n10:15- ASTM E2500- Jesper M. Wagner \n10:45 Plenary Q&A \n11:00 Intro to workshop \n11:15 LUNCH \n12:15 Workshop 1 / Workshop 2 \n13:45 Break & Snacks \n14:10 Workshop 3 \n15:00 Wrap-up \n  \nSPEAKERS\nJesper Wagner\, AlfaNordic \nMarc Vorderman\, Novatek International \nLaurence O’Leary\, ValidEire ApS
URL:https://valideire.com/event/process-validation-workshop/
ATTACH;FMTTYPE=image/jpeg:https://valideire.com/wp-content/uploads/2024/03/PV0921-e1710160417838.jpg
ORGANIZER;CN="Valideire Aps":MAILTO:info@valideire.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Copenhagen:20191023T083000
DTEND;TZID=Europe/Copenhagen:20191024T153000
DTSTAMP:20240313T122025Z
CREATED:20240305T115846Z
LAST-MODIFIED:20240313T122025Z
UID:6539-1571819400-1571931000@valideire.com
SUMMARY:Cleaning Process Development & Validation
DESCRIPTION:23rd-24th October 2019\, Copenhagen\nBy ValidEire ApS and Key2Compliance\, sponsored by Novatek International \n  \nSUMMIT DESCRIPTION\nThis two-day conference put focus on Science\, Risk and Statistics-based Cleaning Process Development and Validation. Presentations will be given on standards\, analytical methods and use of statistics to cleaning validation development\, risk evaluation\, Swab Recovery\, data integrity\, variability\, what’s coming and much more. \n  \nAGENDA\n\n\n\nDay 1 – 23th October\, 2019\nDay 2 – 24th October\, 2019\n\n\n08:30 Breakfast & Networking\n08:30 Breakfast & Networking\n\n\n08:55 Intro by Chairperson\n08:55 Intro by Chairperson\n\n\n09:00-09:45 Introduction to ASTM E3106 “Standard Guide for Science-Based and Risk-Based Cleaning Process Development and Validation” and Upcoming Standards – Andrew Walsh (CPCI)\n09:00-09:45 Statistical Determination of Swab Recovery Factors in Coupon Studies – Ioanna-Maria Gerostathi\n\n\n09:45-10.30 Upcoming ASTM “Standard Guide for the Derivation of Health Based Exposure Limits (HBELs)” for Drugs and Devices – Andreas Flückiger\n09:45-10:30 Data Integrity in Cleaning Validation and Case Study from Novatek International Cleaning Validation Management – Laurence O’Leary (ValidEire) & Susan Cleary (Novatek)\n\n\n10:30 -10:45 Networking break / Coffee & Tea\n10:30-10:45 Networking break / Coffee & Tea\n\n\n10:45-12:00 Analytical Development: a Useful Support for Cleaning Control and Validation – S. Janvier (SERVIER)\n10:45-11:30 Statistically-based Qualification of Visual Inspection to Comply with EMA’s Q&A #8 – Andrew Walsh (CPCI)\n\n\n12:00-13:00 Lunch\n11:30-12:15 Different strategies to establish a rationale for samplings of different residuals – Pierre Devaux (Theraxel)\n\n\n13:00-13:45 Application of Statistics to Cleaning Process Development – Ruijin Song (CPCI)\n12:15-13:00 Lunch\n\n\n13:45-14:30 Use of Statistics for Cleaning Validation – Igor Gorsky (Valsource)\n13:00-13:45 What’s coming? New Equipment\, New Technology\, New Processes – Igor Gorsky (Valsource)\n\n\n14:30-14:45 Networking break / Coffee & Tea\n13:45-14:30 Implementation of “At-Line” PAT using Total Organic Carbon (TOC) Analysis – Andrew Walsh (CPCI)\n\n\n14:45-15:30 Coverage test experience and cycle development – Marilyne Douez (Novo Nordisk)\n15:15 Closing from Chairman\n\n\n15:30-16:15 Application of QRM in Cleaning – Ken Farrugia (Natrix Sciences)\n\n\n\n16:15-17:00 Cleaning Process Risk Evaluation — A Quantitative Framework – Mohammad Ovais\n\n\n\n17:00 Wrap-up\n\n\n\n17:00-18:00 Networking and snacks compliments of sponsor Novatek\n\n\n\n\nSPEAKERS \n\n\n\n \nLaurence O’Leary\nCo-Arranger of Conference\nDiploma of Technology in Biotechnology\, Process Technology and Chemistry\, Lean Six Sigma Green Belt.\n \nPierre Devaux \nPharmacist-CEO Theraxel-Point Forty Five\n\n\n \nIoanna-Maria Gerostathi\nMSc Materials Science and Technology\n \nKenneth Farrugia\nBSc (Hons) MLS\, CertOHS\, DipM\, CertToxicol\n\n\n \nAndrew Walsh\nB.S. and M.S. in Biology (Microbiology)\, certified Lean Six Sigma Black Belt.\n \nJoe Cagnassola\nBsc Biology.\n\n\n \nRuijin (Sophie) Song\nM.S. Chemical Engineering.\n \nMohammad Ovais\n\n\n \nSusan B. Cleary\nB.CS\, M.B.A\n \nAndreas Flückiger\nMD\n\n\n \nMarilyne Douez\nM.S. Chemical Engineering.\n\n\n\n\n  \nSPONSORS\n \nAbout Novatek International\nEstablished in 1996\, Novatek’s mission is dedicated to help pharmaceutical companies and other life science organizations leverage their investment in information technology and quality processes by reducing cost\, improving productivity and enhancing compliance. With over 20 years of user experience and developer level technical support\, simple or complex installations are seamless and rapid. The architecture of all Novatek solutions are out of the box\, modular and process-based\, enabling the applications to be delivered “business-ready” providing the building blocks for a complete quality solution.\nFor more information on Novatek International visit: ntint.com \n  \nARRANGED BY \n \n 
URL:https://valideire.com/event/science-risk-and-statistics_based-cleaning-process-development-and-validation/
ATTACH;FMTTYPE=image/jpeg:https://valideire.com/wp-content/uploads/2024/03/ScienceRisk1019-e1710160451378.jpg
ORGANIZER;CN="Valideire Aps":MAILTO:info@valideire.com
END:VEVENT
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