A Risk Based Approach To Data Integrity ntz

A Risk Based Approach To Data Integrity (ntz)
At
Courtyard by Marriott Arlington Crystal City/Reagan National Airport


DESCRIPTION

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!!

Defined 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 data integrity and data governance. This includes organizational, procedural 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.

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.

Key implementation considerations 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 and developing and providing the appropriate levels of training.
An effective data integrity program includes addressing of behavioral factors and drives a strategy that focuses on prevention, detection, response and continuous improvement.

The Seminar:
This Seminar addresses the integrity of GxP records and data used within the regulated industries including pharmaceutical, biological, medical devices, cosmetics, food and any other industry where data integrity is important. It provides a method for managing risk to record and data integrity. 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

Angela Bazigos
CEO, Touchstone Technologies Silicon Valley

Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
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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