The "Data Integrity and Document Management for GxP Compliance" conference has been added to ResearchAndMarkets.com's offering.
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.
Principles of data integrity and good documentation practice
- What is data integrity?
- Why is data integrity important?
- ALCOA principles
- Good documentation practice including paper and electronic records
Data integrity regulations and guidelines
- MHRA/WHO/FDA/EMA/PICS/ICH GCP R2, Data Integrity guidelines
- Group review and discussion of some key regulated documents including the new MHRA data integrity guide
Document management and data integrity inspection findings
- MHRA, EMA findings, EU non-compliance reports
- FDA findings
- Group discussion on inspection findings
QMS considerations for Data integrity and documentation
- What are the elements of QMS for data integrity?
- Risk management considerations
- Data governance
- Discussion of participants experience and best practice for QMS and data governance
Data integrity for computer systems
- Computer system validation considerations
- What is expected for compliance for GXP systems
Discussion of document and data integrity issues
- Data integrity and digital signatures
- Certified copies/true copies
- Managing and preventing data integrity breaches
Final questions and summary discussion
For more information about this conference visit https://www.researchandmarkets.com/research/rlld8k/1day_course?w=4
Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
Related Topics: Information Management, Pharmaceutical Manufacturing