BEGIN:VCALENDAR VERSION:2.0 PRODID:icalendar-ruby CALSCALE:GREGORIAN BEGIN:VEVENT DTSTAMP:20240328T130438Z UID:22c32ad1-4408-46a1-865a-68e2f939f24b DTSTART:20210420T090000 DTEND:20210421T090000 CLASS:PRIVATE DESCRIPTION:
The impact of Data Integrity issues on a regulated company c an be significant: it can result in recalls of products\, warning or untit led letters\, import alerts\, injunctions\, seizures\, legal action\, etc. These regulatory actions can have significant financial impact to the com pany. However\, and most importantly\, data integrity issues can lead to p otential patient harm!!
\n\nDefined by the Medicines and Healthcare Products Regulatory Agency (MHRA) as "\;the extent which all data are complete\, consistent and accurate throughout the data lifecycle"\;\, data integrity is increasingly the focus of regulatory agencies round the world. Companies must now ensure that they are appropriately addressing da ta integrity and data governance. This includes organizational\, procedura l and technical controls that must be considered as part of an overarching data governance system. In addition\, the effort and resources committed to data integrity must be commensurate with the role it plays in assuring product quality.
\n\nTo ensure Data Integrity\, a GxP regulated comp any needs to abide by principles\, current regulations and industry best p ractices on the expectations for the management GxP regulated records and data. These principles\, regulations and best practices\, ensure that data is complete\, consistent\, accurate\, secure and available throughout the record life cycle. This approach is intended to encourage innovation and technological advances while avoiding unacceptable risk to product quality \, patient safety and public health.
\n\nKey implementation consider ations for a corporate data integrity program\, include development of a h igh-level strategy\, identifying and gaining executive sponsorship\, focus ing on management accountability\, implementing tools for knowledge sharin g and developing and providing the appropriate levels of training. An effe ctive data integrity program includes addressing of behavioral factors and drives a strategy that focuses on prevention\, detection\, response and c ontinuous improvement.
\n\nIntroduction and Background
\n\nData Governance Framework
\n\nQuality Risk Management
\n\nData Lif e Cycle
\n\nData Integrity Management
\n\nAuditing &\; Audit Tr ails
\n\nData Integrity for Electronic Records / Electro nic Signatures (ERES)
\n\nData Conversions p>\n\n
Seasoned Executive with 40 years of experience in the
Life Sciences &\; Healthcare Industries. Positions include Chief Compli
ance Officer \;http://morflearning.com/angelabazigos/. Experience combines Q
uality Assurance\, Regulatory Compliance\, Business Administration\, Infor
mation Technology\, Project Management\, Clinical Lab Science\, Turnaround
s and Business Development. Past employers / clients include Roche\, Novar
tis\, Genentech &\; PriceWaterhouseCoopers. Co-authored &\; prototyp
ed 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinic
al Research w/ FDA \;http://www1.diahome.org/~/media/4
FA562336EBD46C58CDC43A8B7773095.ashx Patent on speeding up software co
mpliance \;https://www.google.com/patents/US8266578. Recently quoted in Wa
ll Street Journal for using training to bring regulatory compliance to the
Boardroom \;http:/
/blogs.wsj.com/riskandcompliance/2021/07/24/using-training-to-bring-compli
ance-to-boardrooms/ \;National Trainer for Society of Quality Assu
rance. Comments / collaborates with FDA on new guidance documents. Former
President of Pacific Regional Chapter of Society of Quality Assurance. Sta
nford'\;s Who'\;s Who for LifeSciences: \;htt
p://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.
\n
\nPlease contact Marilyn Turner: Phone: +1 929 900 1853  \;Em
ail: marilyn.turner [a] nyeventslist.com for registrations