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X-WR-CALDESC:Events for Novatek
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DTSTART;VALUE=DATE:20230906
DTEND;VALUE=DATE:20230908
DTSTAMP:20260709T104446
CREATED:20230809T155349Z
LAST-MODIFIED:20230809T155349Z
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SUMMARY:Quality Risk Management An ICH Q9 Training Course
DESCRIPTION:Join Novatek Europe at ECA Quality Risk Management An ICH Q9 Training Course \n\nSpeakers\n  \nAlexandra Bauloye\, GSK Belgium\nChristof Langer\, OSConsulting\, Austria\nAidan Madden\, FivePharma\, Ireland\nDr Franz Schönfeld\, GMP Inspector\, Germany\n  \n\n\nObjectives\n  \nThis ECA training course deals with the practical implementation of Quality Risk Management (QRM). You will learn how to implement and use QRM approaches to increase efficiency and to meet the expectations of the regulators.\n  \n\n\nBackground\n  \nThe ultimate responsibility for the performance of a medicinal product over its lifetime\, its safety\, quality and efficacy\, lies with the marketing authorisation holder (MAH). To achieve the quality objective\, “there must be a comprehensively designed and correctly implemented system of Quality Assurance incorporating Good Manufacturing Practice\, Quality Control and Quality Risk Management.” [EU-GMP Guidelines\, Part 1\, Chapter 1]. \nQRM was formally introduced to the pharmaceutical industry with the ICH Q9 Guideline\, which has been incorporated in the EU-GMP Guidelines\, Part 3. In the course of implementing ICH Q9\, risk-based approaches increasingly gained in importance. Before that\, it was often the case that processes were defined\, implemented and documented to the latest detail. Now\, based on risk assessments\, more flexibility is possible\, allowing implementing and controlling processes more efficiently. Decisions can be made based on evaluated risks. Unfortunately many companies limit their whole QRM system to the implementation of the FMEA method only. But it is much more than this and QRM can support the pharmaceutical industry in improving their processes and performance.\n  \n\n\nTarget Group\n  \nThis training course is designed for members of staff in pharmaceutical\, biopharmaceutical and API industry’s production and quality units\, who establish\, manage and use quality risk management systems.\n  \n\n\n\nProgramme\n  \nICH Q 9 – Quality Risk Management: an Overview\n\nQRM in non-GxP industries\nQRM in pharma\nHistorical GMP Situation\nICH Q9: current Revision\nQRM tools and techniques\n\nThe Inspector’s View\n\nExpectations\nIntegration in the Pharmaceutical Quality System\nExamples for good and not so good practice\n\nHow to realise Quality Risk Management in a GMP Environment\n\nThe term “quality risk management” is used throughout the GMP guidelines. In this session you will get some practical advice on how implement QRM:\n– Chapter 1\n– Chapter 2\n– Annex 1\n– Annex 15\n– Annex 16\nSOPs needed\nAuditing\n\nInteractive Session: Applying Principles of QMR after an Incident has happened\nA problem has occurred – how to perform a sound Risk Assessment of the situation and come to an appropriate decision.\n\nDesign of an Event Handling System based on a Quality System and Quality Risk Management Approach\n\nQRM in the Quality System\nDesign of an Event Handling system based on QRM and Management Review\nUse of QRM in the evaluation of Events\nExamples\n\nCase Study: Quality Risk Register\n\nWhat is it\, how to develop it and which type of risks to include\nWhat to show to authorities?\nThe way to business continuity\nExamples\n\nHow to implement Quality Risk Management in a pharmaceutical Company\n\nPart 1: QRM Tools made practicable in daily life\n– ICH Q9 and other Norms (with takeaways for Pharma)\n– Strength of practical DMAIC methodology\n– QRM culture: principles and examples\n– Cost of Quality/Compliance\nPart 2: Examples\n– Change Control\n– Monitoring\n– Maintenance
URL:http://52.56.119.59/event/quality-risk-management-an-ich-q9-training-course/
LOCATION:Barcelo Sants Hotel\, Pl. Països Catalans\, Barcelona\, Catalunya\, Spain
CATEGORIES:Conference
ORGANIZER;CN="ECA Foundation":MAILTO:info@eca-foundation.eu
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230920
DTEND;VALUE=DATE:20230922
DTSTAMP:20260709T104446
CREATED:20230608T124327Z
LAST-MODIFIED:20230608T124327Z
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SUMMARY:FarmForum 2023 ||| Madrid\, Spain
DESCRIPTION:Join Novatek Europe at Farmaforum 2023\, the preeminent Pharmaceutical\, Biopharmaceutical\, and Laboratory Technologies Industry Forum\, set to hold its ninth edition in Madrid at the Feria de Madrid’s Hall 14. \nOver the years\, Farmaforum has solidified its reputation as the most significant event for the Pharmaceutical Industry in Spain. It continues to broaden its thematic focus\, establishing synergies with the Biotechnology and Cosmetics Industries through specialized areas such as the Health&Research Forum\, Cosmeticsforum\, Biotechforum\, Nutraforum\, and Cannabisforum. \nFarmaforum boasts an exhibition area complemented by a comprehensive program of conferences and workshops\, featuring dedicated spaces for networking. We’re excited to be part of the event that\, in 2023\, will also host the fifth edition of Labforum – a specialized event dedicated to Materials\, Instrumentation\, Equipment\, and Methods for Laboratory Analysis and Diagnosis. \nAs a side event running parallel to Farmaforum\, Labforum provides a unique focus on the new generation of research and analytical laboratories. Further enhancing the forum’s offerings\, the incorporation of the Health&Research Forum congress will bring the world of research to the fore. \nThe pharmaceutical\, biotechnology\, and cosmetics industries\, to name a few\, hinge on the progress of research for their product launches. Speeding up these processes while ensuring quality and safety has a direct bearing on the costs of new development\, making it a matter of utmost importance for companies. \nBe part of this extraordinary event with NOvatek Europe. Engage with industry leaders\, discuss breakthroughs\, and gain insight into the cutting-edge technologies shaping the future of these industries. We look forward to seeing you there!
URL:http://52.56.119.59/event/farmforum-2023-madrid-spain/
LOCATION:IFEMA Madrid\, Av. del Partenón\, 5\, Madrid\, Spain
CATEGORIES:Conference
ORGANIZER;CN="FarmaForum":MAILTO:info@farmaforum.es
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20231004
DTEND;VALUE=DATE:20231007
DTSTAMP:20260709T104447
CREATED:20230608T125128Z
LAST-MODIFIED:20230608T125254Z
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SUMMARY:The 26th European GERPAC Conference ||| Hyères\, France
DESCRIPTION:Novatek Europe is thrilled to announce our presence at the 26th European scientific days of GERPAC\, taking place on October 4\, 5\, and 6 in Hyères\, France. \nWe warmly invite you to join us at this highly anticipated event focusing on hospital pharmacotechnics\, presented in various engaging formats. \nThis year’s program features conferences spanning various fields of hospital pharmacotechny. Special attention will be given to 3D printing\, risk management in controlled atmosphere areas\, and research on extracellular vesicles as non-viral drug carriers. \nAttendees can look forward to an enriching European Round Table discussion on business continuity in the aftermath of critical situations. Short oral communications\, oral presentation sessions\, and a multimedia competition centered around pharmaceutical technology are sure to stimulate innovative thought and discussion. \nThe event will also feature five interactive workshops in parallel sessions to tackle professional practice topics such as the validation of analytical methods and the establishment of a Cytotoxiq Reconstitution Unit. \nIntermissions and exhibition visits will provide valuable opportunities for networking\, facilitating conversations between attendees\, speakers\, and exhibitors. \nRecognizing the benefits of accessibility\, a remote version of the event will also be available for those unable to attend in person\, similar to the successful format offered in 2022. Simultaneous French-English translation will ensure seamless comprehension during all plenary sessions. \nWe eagerly anticipate the opportunity to meet you at this significant event\, whether that’s in-person or during the remote sessions. \nJoin us for insightful discussions on hospital pharmaceutical technology. We’re looking forward to seeing you there!
URL:http://52.56.119.59/event/the-26th-european-gerpac-conference-hyeres-france/
LOCATION:Belambra Business\, France
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20241017
DTEND;VALUE=DATE:20241019
DTSTAMP:20260709T104447
CREATED:20241015T023619Z
LAST-MODIFIED:20241015T023619Z
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SUMMARY:Quality Assurance and Technical Services (QATS) Symposium
DESCRIPTION:Join Novatek Europe at the QATS Symposium!\nWe’re thrilled to announce that Novatek Europe will be exhibiting at the Quality Assurance and Technical Services (QATS) Symposium on Thursday\, October 17\, and Friday\, October 18 at Stand 57! \nCome visit us at the NHS PASG QATS Symposium to discover how our cutting-edge environmental monitoring and process management solutions can help you achieve your Key Performance Indicators (KPIs). Our tools demonstrate that your production unit or facility is effectively managing your Quality Management System (QMS) and Process Quality System (PQS) in relation to Microbiological Deviations (MDEVs) and Environmental Monitoring Excursions (EMEs). \nLet’s explore innovative strategies for streamlining compliance and enhancing proactive contamination control\, ultimately improving product quality and patient safety. \n Meet our team! We look forward to connecting with industry leaders and experts dedicated to advancing innovation and ensuring patient safety.
URL:http://52.56.119.59/event/quality-assurance-and-technical-services-qats-symposium/
LOCATION:Sutton Coldfield
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20241114
DTEND;VALUE=DATE:20241115
DTSTAMP:20260709T104447
CREATED:20241023T111525Z
LAST-MODIFIED:20241023T111621Z
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SUMMARY:Novatek Europe to Attend the “One Year After the Implementation of Annex 1” Event in Barcelona – 14th November 2024!
DESCRIPTION:Novatek Europe is excited to announce that we will be attending the “One Year After the Implementation of Annex 1” event hosted by A3P Association in Barcelona on 14th November 2024. This important event will delve into the impacts and advancements following the updated Annex 1 guidelines\, which are reshaping the future of pharmaceutical manufacturing and quality assurance. \n\nAs industry leaders\, we are eager to share how our innovative solutions align with these regulatory changes\, helping companies improve compliance and operational efficiency. \nWe look forward to engaging with industry experts\, exchanging ideas\, and exploring new strategies for overcoming the challenges ahead. Join us for a conversation on how we can shape the future of pharmaceutical manufacturing together! \n\n 
URL:http://52.56.119.59/event/novatek-europe-to-attend-the-one-year-after-the-implementation-of-annex-1-event-in-barcelona-14th-november-2024/
LOCATION:Barcelona\, Barcelona\, Spain
CATEGORIES:Conference
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20241120
DTEND;VALUE=DATE:20241122
DTSTAMP:20260709T104447
CREATED:20241113T035207Z
LAST-MODIFIED:20241113T040804Z
UID:2764-1732060800-1732233599@52.56.119.59
SUMMARY:Join Novatek Europe at KNEX Validation University Europe 2024 in Dublin!
DESCRIPTION:[vc_row][vc_column][vc_column_text css=”.vc_custom_1731469789032{margin-bottom: 0px !important;}”]On November 20-21\, the KNEX (Knowledge Exchange Network) hosts a premier event for professionals in life sciences\, featuring hands-on tutorials\, emerging technology discussions\, and key insights into GMP compliance and digital transformation. Don’t miss this chance to network\, learn\, and stay ahead in the industry.[/vc_column_text][/vc_column][/vc_row]
URL:http://52.56.119.59/event/join-novatek-europe-at-knex-validation-university-europe-2024-in-dublin/
LOCATION:Dublin\, Ireland
CATEGORIES:Conference
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