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DTSTART;TZID=UTC:20220316T080000
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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
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20220308
DTEND;VALUE=DATE:20220309
DTSTAMP:20260424T181101
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:20260424T181101
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
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BEGIN:VEVENT
DTSTART;TZID=America/New_York:20220126T090000
DTEND;TZID=America/New_York:20220127T120000
DTSTAMP:20260424T181101
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
ATTACH;FMTTYPE=image/png:https://ntint.com/wp-content/uploads/2016/05/novatek-international-event.png
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BEGIN:VEVENT
DTSTART;TZID=UTC:20220124T080000
DTEND;TZID=UTC:20220127T170000
DTSTAMP:20260424T181101
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:20260424T181101
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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