13-05-2025
Data Integrity and Document Management Training Course: Latest MHRA Data Integrity Guide and EMA TMF Guidelines (ONLINE EVENT: July 14, 2025)
Dublin, May 13, 2025 (GLOBE NEWSWIRE) -- The "Data Integrity and Document Management Training Course" training has been added to offering.
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.
Document management and data integrity are a key focus of 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.
Ensuring data integrity is an important component of the pharma industry's responsibility to guarantee the safety, efficacy, and quality of drugs. Violations relating to document management and data integrity have led to numerous regulatory actions, in- cluding warning letters and critical inspection findings. To address these concerns, the FDA, EMA, MHRA and the World Health Organization (WHO) have all recently published data integrity guidelines.
The programme will include discussion of the latest MHRA data integrity guide and EMA TMF guideline 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
Ensure you are compliant with the new EU trial master file (TMF) guideline
Be aware of key regulations and guidelines
Discuss QMS considerations for data integrity and document management
Review document management and data integrity inspections to facilitate regulatory compliance
Consider the requirements for document management and data integrity governance to prevent data integrity breaches
This course is part of the GxP (Good x Practice) training course collection, which feature a variety of topic areas to ensure you comply with the regulations and quality guidelines.
Certification:
CPD: 6 hours for your records
Certificate of completion
Who Should Attend:
Clinical trials
Manufacturing
Quality assurance/quality control
Compliance
Pharmacovigilance
Key Topics Covered:
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 latest 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
For more information about this training visit
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