Understanding Data Integrity Standards

Description

Data integrity (DI) issues continue to lead to onerous regulatory actions. Such problems can be avoided with a thorough knowledge and understanding of regulatory agency requirements.

Learn how to comply with the expectations of regulatory authorities. This course is designed to give you an overview of what data integrity means and how to create a robust data governance system. Regardless of the format, this new system will help you keep your data complete, consistent, and accurate throughout the data lifecycle.

Why should you participate

The inspections of the last two years by the authorities have shown serious breaches of these principles: data deleted or not taken into account, re-testing until compliance, loss or lack of traceability, non-compliance with ALCOA rules, and data falsification. The FDA has issued several warning letters with points of data non-compliance. In Europe, the authorities (EMA, MHRA, ANSM, etc.) make the same observation and have also issued GMP non-compliances, and injunctions relating to deviations from data integrity. Recently, Health Canada introduced this concept during regulatory inspections because it is a basic principle of GMP regulations and a hot topic worldwide. So why are the competent authorities concerned?

Who should attend

This Pharmaceutical Data Integrity course is beneficial for anyone who operates in a pharmaceutical quality system or performs audits of pharmaceutical manufacturers or their suppliers.

Objectives

At the end of this session, you will be able to:

Recognize and identify key ID requirements and terminologies
Developing an ID program
Manage ID with subcontractors
Develop an ongoing monitoring and governance program
List the top 10 elements for electronic data integrity compliance
Identify and assess the risks related to the integrity of paper and electronic data in your organization