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DTSTART;TZID=UTC:20221010T080000
DTEND;TZID=UTC:20221012T170000
DTSTAMP:20260424T155254
CREATED:20220428T190658Z
LAST-MODIFIED:20220506T175646Z
UID:18921-1665388800-1665594000@ntint.com
SUMMARY:2022 PDA Pharmaceutical Microbiology Conference | Washington\, DC
DESCRIPTION:This Conference continues the ongoing tradition of addressing the opportunities and challenges\, most relevant\, to the future of microbiology in today’s global market. Join new and seasoned professionals from all facets of the field\, including global industry\, academia\, and regulatory authorities\, to share insights on how to best prepare for the future through the sharing of best practices\, development of standards\, and integration of innovative technologies. \nCome join Novatek at booth No. 203! \nNote the latest revision made to PDA Technical Report No. 13:  \nPage 20-21\, section 5.4 on Data Management:\n“Based on the large number of samples tested by a given facility\, a computer-based data-tracking system is essential.”\nIt’s easier than you think and Novatek can help you achieve all of this & more! \n \n  \n  \n 
URL:https://ntint.com/event/2022-pda-pharmaceutical-microbiology-conference-washington-dc/
LOCATION:Grand Hyatt Washington\, 1000 H St NW\, WA\, United States
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220928T080000
DTEND;TZID=UTC:20220929T170000
DTSTAMP:20260424T155254
CREATED:20220505T184348Z
LAST-MODIFIED:20220505T184717Z
UID:18919-1664352000-1664470800@ntint.com
SUMMARY:SPEAKER: Pharma ED Combination Products Summit 2022 | Philadelphia\, PA
DESCRIPTION:Regulators in North America and Europe are requiring stricter standards for the manufacture and safety testing for combination products in both the Pharma and med device industries. \nThis two-day summit features expert insight into CP product development\, and the complex quality\, safety\, and regulatory compliance issues facing the CP market. \nPharma Ed’s Combination Products Summit 2022 provides comprehensive coverage of current and future trends in combination product development for drugs\, biologics and medical devices.
URL:https://ntint.com/event/speaker-pharma-ed-combination-products-summit-2022-philadelphia-pa/
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
ORGANIZER;CN="PharmaED Resources":MAILTO:info@pharmaedresources.com
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220913T080000
DTEND;TZID=UTC:20220914T170000
DTSTAMP:20260424T155254
CREATED:20220818T174127Z
LAST-MODIFIED:20220818T174127Z
UID:19151-1663056000-1663174800@ntint.com
SUMMARY:WEBINAR: PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environment
DESCRIPTION:Novatek will be both speaking and sponsoring September’s ISPE Philippines Affiliate’s webinar on PIC/S Guidance on GMP and Data Integrity.  Novatek will be presenting on Data Integrity best practices and Risk-Based Laboratory Information Management Systems (LIMS). \nWebinar Fee:\nPHP 1\,500.00 – ISPE Members\, FDA\, Government\, and Students \nPHP 2\,500.00 – Non ISPE Members \nRegister at:\nhttps://docs.google.com/forms/d/e/1FAIpQLSd6w8RCmrND1VPLnEaHc1C3EptGOBg2TEuZdexl8eI4PEAcXg/viewform
URL:https://ntint.com/event/webinar-pic-s-guidance-on-good-practices-for-data-management-and-integrity-in-regulated-gmp-gdp-environment/
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220912T080000
DTEND;TZID=UTC:20220914T170000
DTSTAMP:20260424T155254
CREATED:20220818T172656Z
LAST-MODIFIED:20220818T173023Z
UID:19154-1662969600-1663174800@ntint.com
SUMMARY:PDA/FDA Joint Regulatory Conference | Washington\, DC
DESCRIPTION:We are BACK in Washington\, D.C. for one of our favourite PDA events of the year!  Come visit us at booth 46 to learn how Novatek can help you meet today’s Quality Evolution with our Regulatory Compliant Quality Software. \nThis flagship conference provides opportunities for attendees to learn about current issues relating to manufacturing and quality assurance. The Conference emphasizes the role of effective quality systems in ensuring an ongoing state of control throughout the product lifecycle by vigilantly managing risks to manufacturing and quality. \n  \n  \n 
URL:https://ntint.com/event/pda-fda-joint-regulatory-conference-washington-dc/
LOCATION:Renaissance Washington\, DC Downtown Hotel\, 999 9th Street NW\, Washington\, DC\, 20001\, United States
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220817T080000
DTEND;TZID=UTC:20220819T170000
DTSTAMP:20260424T155254
CREATED:20220817T212159Z
LAST-MODIFIED:20220817T212923Z
UID:19146-1660723200-1660928400@ntint.com
SUMMARY:ISPE Singapore Affiliate Conference & Exhibition
DESCRIPTION:Collaboration | Transformation | Digitalization \nJoin manufacturers\, technology and service providers to distil best practices and knowledge. Director of Asia\, Vivien Santillan will be moderating the event’s Women in Pharma Roundtable Discussion & Lunch on Friday August 19. \nEvent Information:\nhttps://www.ispesingapore.org/
URL:https://ntint.com/event/ispe-singapore-affiliate-conference-exhibition/
LOCATION:Suntec Singapore
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220623
DTEND;VALUE=DATE:20220624
DTSTAMP:20260424T155254
CREATED:20220530T213435Z
LAST-MODIFIED:20220530T213803Z
UID:19013-1655942400-1656028799@ntint.com
SUMMARY:PDA Ireland: Pharmaceutical Data Integrity
DESCRIPTION:Novatek will be sponsoring PDA Ireland’s upcoming event\, Pharmaceutical Data Integrity – The Solution Room.  An event that will address Issues\, Challenges\, and Proposed Solutions – Knowledge Sharing in an Interactive Workshop Environment.
URL:https://ntint.com/event/pda-ireland-pharmaceutical-data-integrity/
LOCATION:Castleknock Hotel\, Porterstown Road\, D15 WNR7 D15\, Ireland
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220620T120000
DTEND;TZID=UTC:20220622T170000
DTSTAMP:20260424T155254
CREATED:20220426T205003Z
LAST-MODIFIED:20220506T174007Z
UID:18916-1655726400-1655917200@ntint.com
SUMMARY:SPEAKER: KENX Laboratory University | Philadelphia\, PA
DESCRIPTION:The time has never been greater to stay up-to-speed with current regulatory thinking. Join Novatek at KENX’s Laboratory University and stay up to date with the latest developments and regulations in Analytical Procedures & Methods Validation\, Stability Testing & Program Management\, and FDA Inspections of Quality Control Laboratories. \nNovatek Presentation: Elements of Sample Control-Compliance\, Inventory & Tracking \nSpeaker: Sheba Zaman \nDay 3: June 22\, 2022 @ 12:45 – 1:25 ET \nTake advantage of Novatek’s Promo Code: NOVATEK200 and save $200 of your registration.
URL:https://ntint.com/event/kenx-laboratory-university-philadelphia-pa/
LOCATION:The Wyndham Historic District\, 400 Arch Street\, Philadelphia\, PA\, 19106\, United States
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
GEO:39.9520404;-75.147515
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=The Wyndham Historic District 400 Arch Street Philadelphia PA 19106 United States;X-APPLE-RADIUS=500;X-TITLE=400 Arch Street:geo:-75.147515,39.9520404
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220615
DTEND;VALUE=DATE:20220616
DTSTAMP:20260424T155254
CREATED:20220516T201216Z
LAST-MODIFIED:20220516T221004Z
UID:18996-1655251200-1655337599@ntint.com
SUMMARY:SPEAKER: Annual Bio Event | Tel Aviv\, Israel
DESCRIPTION:Novatek is proud to be participating as a speaker at the Annual Bio Event to be held June 15 in Tel Aviv at the David Intercontinental Hotel.  This conference will provide the most advanced information for understanding the operation and maintaining the quality of the sterile facility. Quality requirements in production and sterile pharmaceutical preparations – what is required\, from the managers and quality people of preparation centers and production facilities\, to understand about the clean rooms. \nNovatek will be presenting on Risk-Based Contamination Control: \nPresentation Title: \nAnnex 1 in The Age of Digitization: Reimagining Contamination Control Presented Virtually by Parsa Famili President & CEO\, Novatek International \nOverview: \n\nOptimized manufacturing and change control\nUsing the Risk-Based Approach in Defining User Requirements\nThe importance of clear roles and responsibilities\nProper determination of Maximum Safe Carryover (MSC)\nHealth-based exposure limits (HBELs)\nThe trends and data analysis that support a total contamination control strategy (CCS)\nHow to correlate or centralize trending of disinfectant qualification\nEffectiveness of cleaning\nRisks in Environmental Monitoring and Utility Monitoring\nPersonnel gowning\, and qualification\nTrending for investigational purposes across all contamination control elements to assist with root cause determination\nDoing Digital or Being Digital
URL:https://ntint.com/event/speaker-annual-bio-event-tel-aviv-israel/
LOCATION:InterContinental David Tel Aviv\, an IHG Hotel\, Kaufmann St 12\, Tel Aviv-Yafo\, 61501\, Israel
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220614
DTEND;VALUE=DATE:20220616
DTSTAMP:20260424T155254
CREATED:20210810T180327Z
LAST-MODIFIED:20220505T195732Z
UID:18367-1655164800-1655337599@ntint.com
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
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220613T080000
DTEND;TZID=UTC:20220616T170000
DTSTAMP:20260424T155254
CREATED:20220426T203254Z
LAST-MODIFIED:20220426T203254Z
UID:18913-1655107200-1655398800@ntint.com
SUMMARY:BIO International Convention | San Diego\, CA
DESCRIPTION:#BIO2022 is back in-person!\n\n\n\n\nThe BIO International Convention is back and in-person. Join Novatek at booth number 1704 June 13-16 in San Diego\, California for four exciting days of networking\, programming\, and partnering opportunities that will shape the future of our industry and celebrate the scientific discoveries transforming our world. \nExplore ‘LIMITLESS’ possibilities alongside thousands of global biotechnology and pharma leaders as we dive into topics such as business development\, healthcare innovations\, and the future of biotechnology.
URL:https://ntint.com/event/bio-international-convention-san-diego-ca/
LOCATION:San Diego Convention Center\, 111 West Harbor Drive \, San Diego\,  92101\, United States
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
GEO:32.7063297;-117.1618414
X-APPLE-STRUCTURED-LOCATION;VALUE=URI;X-ADDRESS=San Diego Convention Center 111 West Harbor Drive  San Diego  92101 United States;X-APPLE-RADIUS=500;X-TITLE=111 West Harbor Drive:geo:-117.1618414,32.7063297
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220516T080000
DTEND;TZID=UTC:20220517T170000
DTSTAMP:20260424T155254
CREATED:20220107T010218Z
LAST-MODIFIED:20220517T020212Z
UID:18751-1652688000-1652806800@ntint.com
SUMMARY:SPEAKER: 2022 PDA Robotics & Automation Conference | Dublin\, Ireland
DESCRIPTION:While concepts of robots and automation might have been considered nice to have a few years ago\, the global pandemic has accelerated the importance of speed while maintaining our standards of safety. We will cover a wide range of topics ranging from artificial intelligence and machine learning\, big data\, data analytics\, digital twins\, cloud solutions and blockchain technology to automated solutions in pharma testing and manufacturing. \nNovatek will be speaking at this event: \nSession 2: Lab Automation\nModerator: Dieter Bachmann\, Janssen J&J \n14:45 I A Glimpse in the Future of Automated in Environmental Monitoring\nAram Montazami\, Novatek\nAnne-Grit Klees\, Merck KGaA
URL:https://ntint.com/event/conference-2022-pda-robotics-and-automation-conference/
LOCATION:Crowne Plaza Dublin Airport
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220504T130000
DTEND;TZID=UTC:20220505T180000
DTSTAMP:20260424T155254
CREATED:20220420T193814Z
LAST-MODIFIED:20220420T193814Z
UID:18903-1651669200-1651773600@ntint.com
SUMMARY:14th Annual Microbial Contamination and Control Conference | PDA Midwest Chapter
DESCRIPTION:Microbial Contamination and Control\nPDA Midwest Chapter is pleased to announce that the chapter will partner with the Hilton Chicago Northbrook Hotel in Northbrook\, IL for one of our signature events\, the 14th Annual Microbial Contamination and Control Conference. \nJoin us on Wednesday and Thursday\, May 4th and 5th for an agenda packed full of thought provoking presentations addressing the opportunities and microbial challenges within the industry. Presentations will include topics such as the danger of poor clean room investigations\, preventing contamination from entering the controlled environments\, contamination control strategies\, particulate matter based on the harmonized USP and guidance chapters\, and much more! \nRefreshment breaks will feature tabletop exhibits\, which will allow for peer-to-peer discussions and exhibitor showcase. In addition\, raffle prizes will be given out after the afternoon break. \nNovatek to be presenting on Data Trending & Analysis for Contamination Control on Day 2 (May 5th). \n 
URL:https://ntint.com/event/14th-annual-microbial-contamination-and-control-conference-pda-midwest-chapter/
LOCATION:Hilton Chicago-Northbrook\, 2855 N. Milwaukee Ave.\, Northbrook\,\, IL\, 60062\, United States
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220427T080000
DTEND;TZID=UTC:20220429T170000
DTSTAMP:20260424T155254
CREATED:20220423T192443Z
LAST-MODIFIED:20220423T192443Z
UID:18910-1651046400-1651251600@ntint.com
SUMMARY:EXPOFARMA 2022 | Mexico City
DESCRIPTION:2022 is here\, and with this new year\, also came the opportunity to attend the best and most important Health Exhibition in Latin America\, which the Mexican Pharmaceutical Association\, A.C. has for you: EXPO FARMA 2022 which is celebrating its 49th Edition. \nThe CDMX WTC awaits you from APRIL 27 to 29\, where national and foreign visitors will have the opportunity to be in direct contact with more than 8\,000 Professionals from the Pharmaceutical\, Chemical\, Cosmetic\, Food\, Hospital Pharmacy\, Pharmaceutical\, Devices Medical and Clinical Analysis. \nLarge Suppliers of the Industry will meet the most prestigious Experts of the country in a single venue. \nNovatek will be in the exhibitor hall for all your inquiries! Booth 1025!
URL:https://ntint.com/event/expofarma-2022-mexico-city/
LOCATION:World Trade Center Mexico City\, Montecito 38\, Nápoles\, Mexico City\, Ciudad de México\, CDMX\, 03810\, Mexico
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220427T080000
DTEND;TZID=UTC:20220429T170000
DTSTAMP:20260424T155254
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:20220425T080000
DTEND;TZID=UTC:20220427T170000
DTSTAMP:20260424T155254
CREATED:20220423T191843Z
LAST-MODIFIED:20220423T191843Z
UID:18907-1650873600-1651078800@ntint.com
SUMMARY:2022 ISPE Europe Annual Conference
DESCRIPTION:Sustainability\, Annex 1\, Digital Quality\, Trends in Pharmaceutical Engineering and Project Management\nInnovation in the market\, digital transformation\, current trends\, successful realizations\, new strategies\, and concepts will be the focus of the 2022 ISPE Europe Annual Conference in Madrid\, Spain. The programme offers an Executive Forum\, dynamic keynote speakers\, four robust tracks and innovative and attractive plant tours. \nJoin us in Madrid\, Spain and learn from case studies about different approaches and applications. You will have the opportunity to meet Novatek’s CEO and Europe Team.  Find us at Booth #4. \nLets converse and exchange experiences about the best ways to approach your company’s digital transformation together! \n 
URL:https://ntint.com/event/2022-ispe-europe-annual-conference/
LOCATION:Hotel Meliá Avenida América\, Calle de Juan Ignacio Luca de Tena\, 36\, Madrid\, Spain
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220407
DTEND;VALUE=DATE:20220408
DTSTAMP:20260424T155254
CREATED:20220107T003215Z
LAST-MODIFIED:20220117T171734Z
UID:18749-1649289600-1649375999@ntint.com
SUMMARY:WORKSHOP: A3P Microbiology
DESCRIPTION:Workshop 1:\nDoing Digtal or Being Digtial ?\nMarc Voderman\nWorkshop 2 &3:\nANNEX-1 Total contamination control using automation\nMarc Voderman\n\n\n\n\nMicrobiological control in the pharmaceutical industry is one of the fundamental pillars to have safe medicines in the market. \nThis year\, your reference association and the A3P Spain Committee invite you to participate in the presential event within the framework of microbiological quality control: \nIncorporate rapid microbiology into pharmaceutical production processes increases productivity and safety\, allows for earlier detection of any contamination and for fast and effective action. \n\n\n\n\nSimultaneous interpretation: English / Spanish
URL:https://ntint.com/event/workshop-a3p-microbiology/
CATEGORIES:Conference
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220404
DTEND;VALUE=DATE:20220407
DTSTAMP:20260424T155254
CREATED:20211217T022334Z
LAST-MODIFIED:20211217T022413Z
UID:18716-1649030400-1649289599@ntint.com
SUMMARY:SPEAKER: 2022 PDA Annual Meeting
DESCRIPTION:Level Up: Agility in the New Normal \nThis Conference will focus on the theme to Level Up: Agility in the New Normal! We will highlight what’s in store for the future of pharmaceutical manufacturing. Examine how companies are developing new modalities and adapting to the current manufacturing environment through the modernization of aging facilities and the adoption of innovative approaches and processes. \nASEPTIC PROCESSING & STERILIZATION SPEAKER:\nDAY 2: Tuesday April 5\, 2022 \nStrategies for Total Contamination Control in an Aseptic Environment\n \nSheba Zaman\, Head of Product Specialists and Training Services\, Novatek \nCome also see us at BOOTH 406 in the Exhibitor Hall!
URL:https://ntint.com/event/speaker-2022-pda-annual-meeting/
LOCATION:Hyatt Regency Dallas\, 300 Reunion Boulevard\, Dallas\, TX\, United States
CATEGORIES:Conference
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220328T080000
DTEND;TZID=UTC:20220330T170000
DTSTAMP:20260424T155254
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
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ORGANIZER;CN="KENX":MAILTO:info@kenx.org
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=UTC:20220323T080000
DTEND;TZID=UTC:20220324T170000
DTSTAMP:20260424T155254
CREATED:20220307T154136Z
LAST-MODIFIED:20220307T154136Z
UID:18835-1648022400-1648141200@ntint.com
SUMMARY:Contamin@Lyon | Lyon France
DESCRIPTION:Novatek is looking forward to exhibiting at Contamin@Lyon this month.  Come find us at Booth 14. \nThis year’s conference theme is 2022 theme is “The fundamentals of the clean room”. \nAll sectors combined\, this conferences will deal with essential and varied topics in the world of clean rooms\, controlled environments and contaminants.
URL:https://ntint.com/event/contaminlyon-lyon-france/
LOCATION:La Sucrière\, 49-50 Quai Rambaud\, Lyon\, LYON\, 69002\, France
CATEGORIES:Conference
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BEGIN:VEVENT
DTSTART;TZID=America/Halifax:20220322T110000
DTEND;TZID=America/Halifax:20220322T120000
DTSTAMP:20260424T155254
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=UTC:20220316T080000
DTEND;TZID=UTC:20220317T170000
DTSTAMP:20260424T155254
CREATED:20220107T191613Z
LAST-MODIFIED:20220225T213647Z
UID:18754-1647417600-1647536400@ntint.com
SUMMARY:WORKSHOP: A3P Validation du Nettoyage | Cleaning Validation
DESCRIPTION:Novatek will be leading workshops and exhibiting at this year’s A3P workshops solely dedicated to the Cleaning Validation process. \nFull details on the workshop (to be provided in French and English) can be found here: https://www.a3p.org/a3p-validation-nettoyage-2022-lille
URL:https://ntint.com/event/workshop-a3p-validation-du-nettoyage-cleaning-validation/
LOCATION:Lille Grand Palais\, 1 Bd des Cités Unies\, 59777 Lille\, France
CATEGORIES:Workshop
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END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220308
DTEND;VALUE=DATE:20220309
DTSTAMP:20260424T155254
CREATED:20220303T033130Z
LAST-MODIFIED:20220303T033130Z
UID:18831-1646697600-1646783999@ntint.com
SUMMARY:PDA Southern California: Full Day Symposium-Risk Management
DESCRIPTION:Novatek is proud to be an annual sponsor for PDA’s Southern California Chapter.  All year long\, we will be working closely together bringing quality events to our industry peers.  Kicking off 2022 with our first sponsored event: \nPDA SoCal Chapter invites you to attend a Full Day Symposium-Risk Management \nRisk Management with a focus on Contamination Control risk mitigation\, Interventions and effects of facility design\, Risk prevention for refrigeration storage using an industry 4.0 solution. \n\nCompliance risks in the cleanroom\nMinimizing risk through RFID\nEmerging trends in risk management with regards to Data Integrity in Car-T\nRemote Audits\n\nOur Keynote Speakers:\n\nSue Schniepp\, Regulatory Compliance Associates\, Inc.\nDan Klein/Steris\nKevin McMurtrie/Veltek\nKimberley Buytaert-Hoefen\, Azzur\nFrances Grinstead/Curis Systems\nLinda Soo Hoo/Gilead\nRobert Chew/CAI\nCarl Patterson/ Latitude Pharma\nJoe Swigurski/Kite Pharma\nLarry Newman/ThermoFisher\nBiana Torres/ Crispr Therapeutics\nTeresa Henry/ Sequoia Consulting
URL:https://ntint.com/event/pda-southern-california-full-day-symposium-risk-management/
CATEGORIES:Conference,Expo
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220224T110000
DTEND;TZID=America/New_York:20220224T120000
DTSTAMP:20260424T155254
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
BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220126T090000
DTEND;TZID=America/New_York:20220127T120000
DTSTAMP:20260424T155254
CREATED:20220107T000418Z
LAST-MODIFIED:20220107T000418Z
UID:18741-1643187600-1643284800@ntint.com
SUMMARY:TRAINING: PDA 612.1 Analysis of Environmental Monitoring Data with Respect to cGMP and Data Integrity Guidelines
DESCRIPTION:This training course offers a deep dive into the analysis required for Environmental Monitoring (EM) with specific consideration to cGMP and Data Integrity guidelines. As such\, the training course is two-fold. The first portion focuses on primarily data analysis for EM. This is for both routine data analysis as well as the analysis required for excursions and investigations with respect to process risks and industry requirements/guidelines. The second portion deals with assessing and maintaining compliance to data integrity guidelines. These two seemingly independent subjects are tied together when we consider that data integrity best practices are required for compliant and meaningful data analysis. Data analysis performed for EM must be risk based\, including assessment of data integrity. Furthermore\, data integrity tools – such as accurately tracing actions through audit trails – can be crucial to investigations\, an area cited by regulators. \nTrainer: \nSheba Zaman \nHead of Product Specialists and Training Services at Novatek International \n\n\n\n\nLearning Objectives\n\n\nConduct detailed EM data analysis for both routine\, state of control monitoring\, including frequency\, filtering data\, grouping data and selection of the meaningful analysis types (e.g. tabular\, regression\, control chart etc.)\nConduct detailed EM data analysis as well as non-routine data analysis for excursions and investigation with an understanding of the regulatory expectations\nExplain the inherent risks in EM data management and their counter measures\nDefine an overview of the general data integrity guidelines from all organizations and identify possible causes of a breach. Demonstrate true understanding of Quality Culture with respect to its effects on data integrity\nDemonstrate the ALCOA+ principles including the reason behind each principle and its applicability in routine operations and root cause analysis\n\n\n\n\n\n\n\n\n\n\nWho Should Attend\n\n\nThis training course is intended for professionals who are involved in viable and non-viable environmental monitoring\, particularly for those investigating or performing data analysis\, including supervision of such analysis.
URL:https://ntint.com/event/training-pda-612-1-analysis-of-environmental-monitoring-data-with-respect-to-cgmp-and-data-integrity-guidelines/
CATEGORIES:Virtual Training
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BEGIN:VEVENT
DTSTART;TZID=UTC:20220124T080000
DTEND;TZID=UTC:20220127T170000
DTSTAMP:20260424T155254
CREATED:20220106T235250Z
LAST-MODIFIED:20220106T235506Z
UID:18736-1643011200-1643302800@ntint.com
SUMMARY:CONFERENCE: Arab Health 2022
DESCRIPTION:Novatek will be attending Arab Health 2022 this January. \nJoin Arab Health\, at the Dubai World Trade Centre this January\, to create meaningful connections and support innovation in healthcare. Get the most out of your participation with the online tool allowing you to start networking before meeting face-to-face in Dubai.
URL:https://ntint.com/event/arab-health-2022/
LOCATION:Dubai World Trade Centre\, Sheikh Zayed Rd\, Dubai\, United Arab Emirates
CATEGORIES:Conference
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BEGIN:VEVENT
DTSTART;TZID=Asia/Shanghai:20220120T093000
DTEND;TZID=Asia/Shanghai:20220120T120000
DTSTAMP:20260424T155254
CREATED:20220106T235942Z
LAST-MODIFIED:20220106T235942Z
UID:18738-1642671000-1642680000@ntint.com
SUMMARY:WEBINAR: ISPE Malaysia - Principles of Cleaning Validation & it’s Regulatory Requirements
DESCRIPTION:This webinar series provides an introductory yet comprehensive overview of cleaning validation principles and requirements that are crucial for ensuring the effectiveness of cleaning as well as compliance with GMP requirements. \nSpeakers: \nVivien Santillan\, Director Asia \nDr. David Vincent\, CEO VTI Lifesciences \nLearning objective: \n\nTo understand the Requirement of cleaning validation in GMP\nTo understand the best practices in Cleaning Validation\nTo understand how the Risk Assessment should be carried out for Cleaning Program\nCase study on Cleaning Validation Program\nTo understand the expectation from GMP Inspector during a routine audit\nSharing of the common observations by pharmaceutical manufacturers\n\nFees: \n\nMember: RM 250\nNon Member: RM 500\nForeign Participants: USD200\n\nRecommended for QA\, QC\, Production\, Technical Services\, Engineering\, Project Management\, Regulatory Affairs. \nNote: E-Certificate of attendance will be provided \n\n\n\n\nThe details for the webinar are:\nDate: 20 January 2022 (Thursday)\nTime: 9.30 AM – 12.00 PM\nPlatform: Zoom
URL:https://ntint.com/event/webinar-ispe-malaysia-principles-of-cleaning-validation-its-regulatory-requirements/
CATEGORIES:Webinar
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