Data Integrity and Document Management for GxP Compliance
Data integrity is now a focus for regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections. It has become a critical issue in document governance and regulators expect staff working in GxP roles to have been trained in this important area.
This concise course covers the background to data integrity, why it is important and how its requirements affect both paper-based and computer-based systems. The course will include discussion of the recently finalised MHRA data integrity guide which provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the GxP pharmaceutical lifecycle (GCP, GMP, GLP and GvP). You will gain an understanding of the requirements for ensuring data integrity, review data integrity inspection findings, and get practical advice on defining and implementing an appropriate data governance process for compliance with data integrity requirements.
Benefits of attending:
- Understand the importance of data integrity and good document practice
- Discuss data integrity criteria and definitions – eg ALCOA
- Be aware of key regulations and guidelines
- Understand QMS considerations for data integrity and document management
- Review document management and data integrity inspections to facilitate regulatory compliance
- Consider the requirements for data integrity governance to prevent data integrity breaches
Who should attend?
This course is designed for managers and staff from all GxP areas in the pharmaceutical and medical device industries who are responsible for the creation, review, approval and/or reporting of data to ensure data integrity, in particular those working in:
- Clinical trials
- Quality assurance/quality control
- QA personnel from CROs/CMOs and GxP auditors responsible for carrying out audits and self-inspections or external audits will also benefit from the programme.