ISPE GAMP Guide: Records and Data Integrity (NTZ)<br />At<br />Courtyard Seattle Sea-Tac Area<br />For more information: https://www.eventbrite.com/e/ispe-gamp-guide-records-and-data-integrity-ntz-tickets-43441116549?aff=RMV<br /><br />DESCRIPTION<br />===========<br />ISPE GAMP Guide: Records and Data Integrity<br />The impact of Data Integrity issues on a regulated company can be significant: it can result in recalls of products, warning or untitled letters, import alerts, injunctions, seizures, legal action, etc. These regulatory actions can have significant financial impact to the company. <br />However, and most importantly, data integrity issues can lead to potential patient harm!!<br /><br />To ensure Data Integrity, a GxP regulated company needs to abide by principles, current regulations and industry best practices 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.<br /><br /><br />The Seminar<br />============<br />Learning Objectives for the seminar include:<br />Data Integrity Requirements<br />Critical Areas of Regulatory Focus and Concern<br />Key Concepts<br />A Framework for Data Governance and Human Factors<br />A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction<br />How to Apply Risk Management to Data Integrity<br /><br />Why you should attend:<br />=======================<br />VP of IT<br />Director of IT<br />Quality Managers<br />Project Managers (for CSV / IT)<br />Validation Specialists<br />Database Administrators<br />System Administrators<br />Directors / Senior Directors of Discovery<br />Directors / Senior Directors of Development<br />Directors / Senior Directors of Commercialization<br />Document Managers<br />Training Managers<br />Regulators<br />Vendors<br />Suppliers<br />Outsource Service Providers<br />Industries<br />Pharmaceuticals<br />Biotech<br />Medical Device<br />Radiological Health<br />Blood Products<br />Companion Animals<br />Food<br />Cosmetics<br />Tobacco<br />Academia<br />AGENDA<br /><br /><br />Please contact the event manager Marilyn below for the following:<br />- Discounts for registering 5 or more participants.<br />- If your company requires a price quotation.<br />Event Manager Contact: marilyn.b.turner(at)nyeventslist.com<br />You can also contact us if you require a visa invitation letter, after ticket purchase.<br />We can also provide a certificate of completion for this event if required.<br />----------------------------------<br /><br />For more information: https://www.eventbrite.com/e/ispe-gamp-guide-records-and-data-integrity-ntz-tickets-43441116549?aff=RMV<br /><br />Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675<br />Twitter: https://twitter.com/nyeventslist<br />Facebook: https://www.facebook.com/NewYorkEventsList<br />New York Events List: http://nyeventslist.com/<br />
