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.
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
Day 1 Schedule
Lecture 1: Introduction and Background
Lecture 2: Data Governance Framework
Lecture 3: Quality Risk Management
Lecture 4: Data Life Cycle
Day 2 Schedule
Lecture 5: Data Integrity Management
Lecture 6: Auditing & Audit Trails
Lecture 7: Data Integrity for Electronic Records / Electronic Signatures (ERES)
Lecture 8: Data Conversions
CEO, Touchstone Technologies Silicon Valley
Four Points Sheraton, Los Angeles