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DTSTART;VALUE=DATE:20260319
DTEND;VALUE=DATE:20260321
DTSTAMP:20260531T143721
CREATED:20260220T153532Z
LAST-MODIFIED:20260226T185117Z
UID:20355-1773878400-1774051199@ntint.com
SUMMARY:KENX - Validation University
DESCRIPTION:We’ll meet you in Philadelphia on March 19-20! \n  \nBe sure to attend Susan Cleary‘s talk on Digitalization Of Cleaning Validation Management! \nKalid Kassaby will also be there to introduce you to key points which would upgrade your position in the industry. (Kalid Kassaby | LinkedIn) \n  \nDate: March 19-20\, 2026\nVenue: Wyndham Philadelphia Historic District + Virtual\nRegister Here: https://kenx.org/conferences/validation-university/\nPromo Code: NOVA200\n  \nHere are the Key Takeaways from Susan’s talk. \n\nUnderstand the fundamentals of cleaning validation and its regulatory importance in ensuring product safety\, quality\, and compliance with GMP requirements.\nIdentify the limitations of traditional paper-based cleaning validation systems\, including inefficiencies\, data integrity risks\, and compliance challenges.\nExplore how digital tools improve cleaning validation management\, including automated workflows\, electronic records\, and real-time monitoring.\nLearn how digitalization enhances data integrity\, traceability\, and audit readiness through secure\, centralized\, and compliant data management systems.\nDiscover best practices and key considerations for implementing digital cleaning validation solutions\, including change management\, system validation\, and regulatory alignment.
URL:https://ntint.com/event/kenx-validation-university/
LOCATION:Wyndham Philadelphia Historic District\, 400 Arch Street\, Philadelphia\, 19106\, United States
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2026/02/07.-KENX-Validation-University.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
GEO:39.9518939;-75.1473609
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20251119
DTEND;VALUE=DATE:20251121
DTSTAMP:20260531T143721
CREATED:20251107T210947Z
LAST-MODIFIED:20251107T210947Z
UID:20263-1763510400-1763683199@ntint.com
SUMMARY:KENX - AI in GxP Europe
DESCRIPTION:Join Parsa Famili and Niccolo Moreno on November 19-20 in Dublin\, Ireland.\n  \n\nWelcome to Harness the Power of AI in GxP Europe\n\n\nUse Cases\, Process Optimization\, and Validation\, in beautiful Dublin\, Ireland! \nNovember 19-20\, 2025 | Dublin\, Ireland \n\n\nJoin us for an immersive 2-day event focused on leveraging and validating Artificial Intelligence (AI) to drive innovation and efficiency within the GxP environment. “Harness the Power of AI in GxP” will feature a series of case study driven sessions that reveal the latest developments in AI applications\, process optimization\, validation\, and compliance within regulated life sciences industries. Whether your goal is to validate AI for regulatory compliance\, streamline manufacturing\, or ensure data integrity\, this conference delivers actionable insights to keep you at the forefront of technology and regulation. \n\n\nSession Highlights: Dive into Real-World Use Cases and Compliance Strategies\n\n\nUnderstanding Regulatory Frameworks for AI in GxP\n\n\nExplore essential regulatory considerations\, including FDA guidance on AI\, Part 11 compliance for electronic records\, and the latest on data integrity standards. Industry experts will provide insights into ISPE® AI quality and compliance initiative and discuss how to ensure alignment with global standards. \n\n\n\nNavigating FDA guidance on AI/ML in life sciences\nPart 11 compliance: Ensuring secure and accurate electronic records\nISPE® AI Quality and Compliance Initiative: An in-depth overview\nAddressing data integrity challenges in AI-driven processes\nManaging regulatory expectations across global markets\nEnsuring transparency and accountability in AI validation processes\n\n\n\nCase Studies and Validation of AI in GxP\n\n\nLearn from specific use cases demonstrating how AI is transforming GxP processes. Topics include optimizing manufacturing workflows\, enhancing validation accuracy\, and applying predictive analytics in quality control. Sessions will also cover best practices for validating AI processes to meet compliance requirements\, ensuring safe and effective AI implementation in regulated environments. \n\n\n\nAI-driven automation in GMP environments: Practical examples\nOptimizing quality control and data integrity through AI\nBest practices for validating AI algorithms and models\nLeveraging predictive analytics for preventive maintenance\nCase study: AI applications in continuous process improvement\nEnhancing validation speed and accuracy with AI\nReal-world applications of AI in manufacturing and supply chain
URL:https://ntint.com/event/kenx-ai-in-gxp-europe/
LOCATION:Hyatt Centric DUBLIN\, IRELAND\, Dublin\, Ireland
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2025/11/Novatek-X-KENX-AI-in-GxP-Dublin.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20251009
DTEND;VALUE=DATE:20251011
DTSTAMP:20260531T143721
CREATED:20250909T161737Z
LAST-MODIFIED:20250910T182324Z
UID:20184-1759968000-1760140799@ntint.com
SUMMARY:KENX - GMP University
DESCRIPTION:Don’t forget to use our discount code: NOVA200 \nOur SME (Subject Matter Expert) Sheba Zaman will be available to answer all your questions about upgrading compliance of your process. \n  \nGMP University 2025 takes a deeper dive into advanced GMP topics and the latest industry trends. This two-day conference in La Jolla\, CA is designed for professionals who want to stay at the forefront of Good Manufacturing Practices\, explore new technologies\, and learn how to implement best practices for regulatory compliance and operational excellence. \nWhat You’ll Gain: \nGMP University 2025 focuses on emerging challenges and innovations in the GMP landscape\, offering insights into the future of compliance and quality assurance. Key topics include: \n\nModernizing Quality Systems: Learn about the latest approaches to building resilient and agile quality systems that adapt to regulatory changes.\nDigital Transformation in GMP: Discover how automation\, data analytics\, and digital tools are reshaping GMP processes\, from documentation to quality control.\nRisk Management & Continuous Improvement: Explore advanced risk management strategies that support continuous improvement and help maintain compliance.\nSupplier & Supply Chain Management: Gain insights into GMP compliance across global supply chains\, including supplier qualification and risk mitigation.\nRegulatory Updates & Compliance: Stay informed about current and upcoming regulatory changes and understand what they mean for your operations.\n\nEvent Highlights: \n\nExpert-Led Sessions & Case Studies: Participate in in-depth presentations and case studies from industry leaders who are innovating in GMP.\nWorkshops & Hands-On Learning: Take part in interactive workshops that focus on applying new GMP trends and best practices in real-world scenarios.\nPanel Discussions & Roundtables: Join discussions with experts on hot topics like digital compliance\, quality metrics\, and regulatory expectations.\nNetworking with Industry Leaders: Connect with peers\, vendors\, and key opinion leaders to share insights\, explore challenges\, and build partnerships.\n\n 
URL:https://ntint.com/event/kenx-gmp-university/
LOCATION:San Diego Marriot La Jolla\, 4240 La Jolla Village Drive\, La Jolla\, CA\, 92037\, United States
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2025/09/Novatek-X-KENX-GMP-University-San-Diego.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250805
DTEND;VALUE=DATE:20250807
DTSTAMP:20260531T143721
CREATED:20250717T192046Z
LAST-MODIFIED:20250717T192046Z
UID:20145-1754352000-1754524799@ntint.com
SUMMARY:KENX - Sterility Assurance University
DESCRIPTION:Sterility Assurance University is the industry’s most focused event dedicated to microbiology\, contamination control strategy (CCS)\, and sterility assurance across the product lifecycle. This two-day summit brings together leading experts from pharma\, biopharma\, and device organizations to share actionable insights on Annex 1 implementation\, environmental monitoring\, aseptic processing\, and cleaning validation — including lifecycle development\, data-driven approaches\, and regulatory alignment. Whether you’re preparing for inspections or proactively strengthening your programs\, this is your go-to event for expert guidance\, peer networking\, and practical tools.
URL:https://ntint.com/event/kenx-sterility-assurance-university/
LOCATION:Hilton Philadelphia at Penns Landing\, 201 S Christopher Columbus Blvd\, Philadelphia\, PA\, 19106\, United States
ATTACH;FMTTYPE=image/webp:https://ntint.com/wp-content/uploads/2025/07/Sterile-2025.webp
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250326
DTEND;VALUE=DATE:20250328
DTSTAMP:20260531T143721
CREATED:20250303T193245Z
LAST-MODIFIED:20250303T193245Z
UID:20061-1742947200-1743119999@ntint.com
SUMMARY:KENX Validation University 2025
DESCRIPTION:An event for QA\, Validation\, Engineering\, IT\, and RA professionals working in the pharmaceutical\, biopharmaceutical\, and medical device industries. \n  \nHighlighted Sessions: \n\nModernizing Process Validation: Strategies for Stage 1-3 Compliance and Efficiency\nCSV 4.0: Validating AI\, SaaS\, and Cloud-Based Systems\nContinuous Validation: Staying Compliant in Rapidly Evolving Environments\nNext-Gen Cleaning Validation: Integrating Risk-Based Approaches and Visual Inspection\nRisk-Based Approach to Computer Systems Validation: Simplifying Compliance\nFacility Qualification: Ensuring Regulatory Compliance Through Effective Design and Execution\nQuality Risk Management (QRM): Integrating ICH Q9 into Validation Processes\nAutomated Validation Systems: Reducing Human Error and Increasing Efficiency\n\nTrends: \n\nComputer Software Assurance (CSA): Shifting from Compliance to Critical Thinking\nValidation in Continuous Manufacturing: Ensuring Compliance in Real-Time Processes\nLean Validation: Driving Efficiency and Reducing Costs in Complex Projects\nData Integrity Beyond ALCOA: Addressing Current Challenges in Digital Validation\nValidation Master Plans: Blueprinting Success for Compliance and Efficiency\nSingle-Use Systems in Validation: Balancing Flexibility and Compliance\nAudit Trails: Ensuring Data Integrity in a Digital Era
URL:https://ntint.com/event/kenx-validation-university-2025/
LOCATION:DoubleTree Philadelphia Center City\, 237 South Broad Street\, Philadelphia\, PA\, 19107\, United States
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2025/03/kenx-val-u.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20230328T080000
DTEND;TZID=UTC:20230330T170000
DTSTAMP:20260531T143721
CREATED:20230116T075540Z
LAST-MODIFIED:20230116T075540Z
UID:19884-1679990400-1680195600@ntint.com
SUMMARY:KENX Validation University | Philadelphia\, PA
DESCRIPTION:Join us this year at KENX’s Validation University for hands-on training for engineering\, quality\, C&Q and validation professionals within the pharmaceutical\, biotech\, medical device and related industries. Participants can create-their-own-experience by choosing from over 55 tutorials and benefit from the wealth of knowledge and useful material our faculty exchanges. Val-U offers a hands-on experience in which lessons learned turn into immediate\, actionable results. \nNovatek’s Presentations: \nTuesday March 28\, 2023 | 11:00 am – 12:00 pm\nPanel Discussion: Navigate the Maze of Regulatory Guidance Shaping Validation – CSA\, Data Integrity\, Quality Metrics\, GAMP® 5\, Annex 1\, Annex 11\, ICH Q9 r1 and More \nThurday March 30\, 2023 | 11:35 am – 12:15 pm\nCleaning Validation Hot Topics – Project Management\, Equipment Grouping\, and Clean Hold Times
URL:https://ntint.com/event/kenx-validation-university-philadelphia-pa/
LOCATION:The Double Tree by Hilton\, 237 S Broad St\, Philadelphia\, PA\, 19107\, USA
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20221213T103000
DTEND;TZID=UTC:20221213T170000
DTSTAMP:20260531T143721
CREATED:20221125T183532Z
LAST-MODIFIED:20221125T183532Z
UID:19782-1670927400-1670950800@ntint.com
SUMMARY:Aseptic Processing Virtual Training
DESCRIPTION:This one-day virtual training delivers the knowledge and tools needed to implement best-in-class procedures in aseptic processing. The elite faculty covers recent changes to Annex 1\, aseptic principles\, facility design\, development\, implementation and validation\, media fills\, data analysis\, and inspection readiness. \n\nUnderstand What the Recent Changes for Annex 1 Mean for You\nModernize Your Aseptic Processing Procedures\nKnowledge Management – Review Recent 483s and Avoid Non-Compliance\nLearn Effective Design Criteria and Program Maintenance Processes\nDevelop and Implement Environmental Control\, Cleaning\, and Sanitization Programs\nUnderstand Aseptic Principles\, Component Sterilization\, and Single Use Technology\nOvercome Common Problems in Sterilization\nLearn Alternative Methods in Aseptic Processing – Isolator Usage\, Blow Fill and Seal Technology\, Restricted Access Barrier Systems (RABS)\nLearn How to Manage Media Fills – Frequency and Size\, Duration\, Manipulation\, Incubation Methods\, Failure Investigations\, Corrective Actions\, SOPs\nImplement a Risk- and Quality System-based Approach to Aseptic Processes\n\nFaculty:\nJR Humbert – Vice President\, Quality\, INCOG BioPharma Services\nParsa Famili\, MSc – President & CEO\, Novatek International\nSheba Zama – Head Of Product Specialists And Training Services\, Novatek International\nDavid W. Vincent\, MPH\, Ph.D. – Chief Scientific Officer\, VTI Life Sciences \n  \n 
URL:https://ntint.com/event/aseptic-processing-virtual-training/
CATEGORIES:Virtual Training
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20221121T080000
DTEND;TZID=UTC:20221123T170000
DTSTAMP:20260531T143721
CREATED:20220818T180244Z
LAST-MODIFIED:20220830T203242Z
UID:19160-1669017600-1669222800@ntint.com
SUMMARY:KENX Validation University Europe | Dublin\, Ireland
DESCRIPTION:Attend Virtually or in Dublin\, Ireland! \nKnowledge Exchange Network (KENX) is extremely excited to announce Validation & GMP University is returning to Europe this November! This is Europe’s leading validation and QMS event. Do not miss this opportunity to network with leading experts and like-minded colleagues leading the charge for best practices in validating processes\, cleaning\, equipment\, facilities\, utilities\, quality systems & metrics\, change control\, risk management\, inspections and so much more! Participants can create their own experience by choosing from over fifty tutorials and benefit from the wealth of knowledge that will have immediate impact on their professional development and organizations. \nNovatek will be both speaking and sponsoring at this year’s event!  Looking forward to meeting you there. Contact us directly for a group or individual discounts. \nTo Register:\nhttps://kenx.org/conferences/europe/
URL:https://ntint.com/event/kenx-validation-university-europe-dublin/
LOCATION:The Spencer Hotel\, Excise Walk\, IFSC\, Dublin\, D01 X4C9\, Ireland
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220427T080000
DTEND;TZID=UTC:20220429T170000
DTSTAMP:20260531T143721
CREATED:20220107T001505Z
LAST-MODIFIED:20220112T000417Z
UID:18743-1651046400-1651251600@ntint.com
SUMMARY:HYBRID CONFERENCE & SPEAKER: KENX Cleanroom Validation\, Disinfection & EM
DESCRIPTION:SAVE $200 off your registration with CODE: Novatek200 \nWith the impending changes of Annex 1 as it applies the sterile environment and FDA’s Quality Consideration in Non-Sterile Drug Manufacturing Draft Guidance\, the time has never been greater to ensure you have procedures mastered to comply with regulatory authorities. KENX’s hybrid conference showcases those paving the way in best practices in cleanroom qualification\, disinfection\, contamination control\, environmental monitoring and more. As a bonus\, the event is co-located with Cleaning Validation and Critical Cleaning Processes and has over 40 tutorials to enhance your professional development. \nJoin KENX at industry’s cleanroom validation event of the year! Whether you’re in QA\, validation\, or engineering; a novice or advanced professional; or\, attending in-person or online\, this is your chance to network with over 200 of like-minded colleagues in the FDA-regulated environment. \nNovatek Speaker Session: \nTrending as part of a contamination control strategy  \nSusan Cleary B.CS\, EMBA – Direct Product Development\, Novatek International \n\nOverview on regulations and guidelines on EM data analysis\nUnderstand EM Trending Requirements\nLearn How to Trend & Analyze Environmental Monitoring Data\nConsiderations for EM data analysis using computerized systems\n\nTakeaway Tools \n\nExample Trend Reports\nRoot cause assessment data fields list\nTrending requirements examples for on demand\, weekly\, monthly\, quarterly\, and annual review
URL:https://ntint.com/event/hybrid-conference-kenx-cleanroom-validation-disinfection-em/
CATEGORIES:Conference,Virtual Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220328T080000
DTEND;TZID=UTC:20220330T170000
DTSTAMP:20260531T143721
CREATED:20220107T002013Z
LAST-MODIFIED:20220112T000204Z
UID:18745-1648454400-1648659600@ntint.com
SUMMARY:HYBRID CONFERENCE & SPEAKER: KENX Validation University
DESCRIPTION:SAVE $200 off your registration with CODE: Novatek200 \n55 Tutorials Overflowing with Rich Content and Tangible Takeaways for the CQV Universe\nFacility Commissioning & Equipment Qualification\n\nImplement a Risk-based Verification Strategy\nDesign a Risk-based IQ\, OQ\, and PQ Approach\nManage Process Validation Tech Transfers\nQualify Critical Utility Systems – HVAC\, Water and Gas\n\nProcess Validation\n\nLearn How To Use Statistics in Validation – Statistics for Non-Statisticians\nImplement a 3-Stage Process Validation Approach\nMaster the Validation Master Plan (VMP)\nConduct Risk-based Continued Process Verfications\n\n Cleaning Validation\n\nUnderstand Key Elements to a Successful Program\nEstablish Cleaning Residue Limits and Acceptance Criteria\nEstablishing Bioburden and Endotoxin limits for Sterile and Non-sterile Products and Processes\nReceive a Cleaning Validation Assessment Checklist Example\n\n Computer System Validation\n\nStay up to speed with FDA’s Computer Software Assurance proposed draft\nImplement a Risk-Based CSV Program Enterprise-Wide\nDevelop and Validate SAAS\, IAAS\, and Other Software Programs\nQualify Network Infrastructure and Cloud Environments\n\n\nPersonnel In The Following Environments Should Attend:\n\nValidation\nQA/QC\nEngineering\nC&Q\nRegulatory and Compliance\nFacility Management\nManufacturing\nLaboratory
URL:https://ntint.com/event/hybrid-conference-speaker-kenx-validation-university/
CATEGORIES:Conference,Virtual Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/Halifax:20220322T110000
DTEND;TZID=America/Halifax:20220322T120000
DTSTAMP:20260531T143721
CREATED:20220303T032216Z
LAST-MODIFIED:20220303T032216Z
UID:18826-1647946800-1647950400@ntint.com
SUMMARY:COMPLIMENTARY WEBINAR: Automation & Trending for a Total Contamination Control Strategy
DESCRIPTION:The regulations are evolving as are the processes we use to validate and monitor controlled areas and utility systems.  Automating these processes and digitizing the data is a must to ensure regulatory compliance and process control.  This session will review the regulations regarding the trending and data analysis requirements and which trending tools are applicable for the process and the data. \n\nPinpoint the regulations which relate to trending and data analysis requirements\nUnderstand automation and data collection\nLearn the difference between discreet and continuous monitoring\nIdentify meaningful data sets and data groupings\nApply Data Analysis\, Trends\, and Pattern recognition tools\nKnow which trending tools are appropriate for the process\nLink Data Integrity\, Digitization\, and Efficiency.\n\nSpeaker: \nSusan B. Cleary\, B.Cs\, M.B.A. Director of Product Development – Novatek International \nRegister for Free: \nhttps://kenx.org/webinar/automation-and-trending-for-a-total-contamination-control-strategy/
URL:https://ntint.com/event/complimentary-webinar-automation-trending-for-a-total-contamination-control-strategy/
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220224T110000
DTEND;TZID=America/New_York:20220224T120000
DTSTAMP:20260531T143721
CREATED:20220208T203457Z
LAST-MODIFIED:20220208T203530Z
UID:18795-1645700400-1645704000@ntint.com
SUMMARY:Digitizing your Cleaning Validation Program and Strategy
DESCRIPTION:European Annex 1 encourages companies to develop a “Total Contamination Control Strategy” (TCCS). TCCS starts with proper determination of Maximum Safe Carryover (MSC)\, calculated based on health-based exposure limits (HBELs)\, a routine cleaning program to evaluate effectiveness of the steps used\, followed by microbial Environmental Monitoring\, Water and Utilities Monitoring\, HVAC filter qualifications\, Media Fills\, and personnel monitoring\, which completes the contamination control cycle. \n\nUnderstand Automation Considerations including Data Integrity\nBe able to properly identify Cleaning Validation Program Risks\nLearn Risk Mitigation Strategies through Digitization\nSee a Case Example of Automating MSC/HBELs & Worst-Case Product/API\nStrategies for Harmonizing of CV Master Data Tables\nView Routine Trends and Analysis used in a digitized CV Program\nLearn to Correlate data for assistance with Root Cause Determination using various Trends and Analysis methods\nView common process flow metrics and KPIs\n\nFree Registration Here: https://register.gotowebinar.com/register/91224328922183521430
URL:https://ntint.com/event/digitizing-your-cleaning-validation-program-and-strategy/
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
END:VCALENDAR