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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
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DTSTART;TZID=America/Halifax:20220322T110000
DTEND;TZID=America/Halifax:20220322T120000
DTSTAMP:20260606T120103
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
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DTSTART;TZID=America/New_York:20220224T110000
DTEND;TZID=America/New_York:20220224T120000
DTSTAMP:20260606T120103
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=Asia/Shanghai:20220120T093000
DTEND;TZID=Asia/Shanghai:20220120T120000
DTSTAMP:20260606T120103
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
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
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