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 provide you with an overview of what is meant by data integrity 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, up to 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, injunctions relating to deviations from data integrity. Recently, Health Canada has introduced this concept during regulatory inspections because it is a basic principle of GMP regulations and a hot topic all over the world. 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
Education Approach
- The course sessions are illustrated with examples based on case studies
- Practical exercises include examples and discussions
