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\n\nThe impact of Data Integri ty issues on a regulated company can be significant: it can result in reca lls of products\, warning or untitled letters\, import alerts\, injunction s\, seizures\, legal action\, etc. These regulatory actions can have signi ficant financial impact to the company. However\, and most importantly\, d ata integrity issues can lead to potential patient harm!!
\n\nDefined by the Medicines and Healthcare Pro ducts Regulatory Agency (MHRA) as "\;the extent which all data are com plete\, consistent and accurate throughout the data lifecycle"\;\, dat a integrity is increasingly the focus of regulatory agencies round the wor ld. Companies must now ensure that they are appropriately addressing data integrity and data governance. This includes organizational\, procedural a nd technical controls that must be considered as part of an overarching da ta governance system. In addition\, the effort and resources committed to data integrity must be commensurate with the role it plays in assuring pro duct quality.
\n\nTo ensure Dat a Integrity\, a GxP regulated company needs to abide by principles\, curre nt regulations and industry best practices on the expectations for the man agement GxP regulated records and data. These principles\, regulations and best practices\, ensure that data is complete\, consistent\, accurate\, s ecure and available throughout the record life cycle. This approach is int ended to encourage innovation and technological advances while avoiding un acceptable risk to product quality\, patient safety and public health.
\n\nKey implementation considerati ons for a corporate data integrity program\, include development of a high -level strategy\, identifying and gaining executive sponsorship\, focusing on management accountability\, implementing tools for knowledge sharing a nd developing and providing the appropriate levels of training. An effecti ve data integrity program includes addressing of behavioral factors and dr ives a strategy that focuses on prevention\, detection\, response and cont inuous improvement.
\n\nThis Semina r addresses the integrity of GxP records and data used within the regulate d industries including pharmaceutical\, biological\, medical devices\, cos metics\, food and any other industry where data integrity is important. It provides a method for managing risk to record and data integrity. Learnin g Objectives for the seminar include:
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\n\nIntroduction and Background
\n\nData Go vernance Framework
\n\nQuality Risk Management p>\n\n
Data Life Cycle< /p>\n\n
Data Integrity Management
\n\nAuditing &\; Audit Trails
\n\nData Integrity for Electronic Records / Electronic Signatures (ERES)
\n\nDat a Conversions
\n\nQuiz: Jeopardy!!!!
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\n\nCEO\, Touchstone Technologies Silicon Valley
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Seasoned Executive with 40 years of experience in the Life Sciences &\; Healthcare Industries. Positions in clude Chief Compliance Officer http://morflearning.com/angelabazigos/. Exp erience combines Quality Assurance\, Regulatory Compliance\, Business Admi nistration\, Information Technology\, Project Management\, Clinical Lab Sc ience\, Turnarounds and Business Development. Past employers / clients inc lude Roche\, Novartis\, Genentech &\; PriceWaterhouseCoopers. Co-author ed &\; prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA http://www1.diahome.org/~/media/4FA56 2336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software compliance https://www.google.com/patents/US8266578. Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroom http://blogs.wsj.com/riskandcompliance/2021/07/24/using-training-to-bring -compliance-to-boardrooms/ National Trainer for Society of Quality Assuran ce. Comments / collaborates with FDA on new guidance documents. Former Pre sident of Pacific Regional Chapter of Society of Quality Assurance. Stanfo rd'\;s Who'\;s Who for LifeSciences: http://www.stanfordwhoswho.com/ Angela.Bazigos.7144112.html#overview.
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