ISPE GAMP Guide: Records and Data Integrity (NTZ)
At
Courtyard Seattle Sea-Tac Area
For more information: https://www.eventbrite.com/e/ispe-gamp-guide-records-and-data-integrity-ntz-tickets-43441116549?aff=RMV
DESCRIPTION
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ISPE GAMP Guide: Records and Data Integrity
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.
However, and most importantly, data integrity issues can lead to potential patient harm!!
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.
The Seminar
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Learning Objectives for the seminar include:
Data Integrity Requirements
Critical Areas of Regulatory Focus and Concern
Key Concepts
A Framework for Data Governance and Human Factors
A Complete Data Life Cycle Approach as Part of a Quality Management System, from Creation to Destruction
How to Apply Risk Management to Data Integrity
Why you should attend:
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VP of IT
Director of IT
Quality Managers
Project Managers (for CSV / IT)
Validation Specialists
Database Administrators
System Administrators
Directors / Senior Directors of Discovery
Directors / Senior Directors of Development
Directors / Senior Directors of Commercialization
Document Managers
Training Managers
Regulators
Vendors
Suppliers
Outsource Service Providers
Industries
Pharmaceuticals
Biotech
Medical Device
Radiological Health
Blood Products
Companion Animals
Food
Cosmetics
Tobacco
Academia
AGENDA
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/ispe-gamp-guide-records-and-data-integrity-ntz-tickets-43441116549?aff=RMV
Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
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