Data Integrity and Document Management in the GxP Pharmaceutical Lifecycle (GCP, GMP, GLP and GvP): Latest MHRA Data Integrity Guide and EMA TMF Guideline (ONLINE EVENT: June 22, 2026)
Dublin, April 15, 2026 (GLOBE NEWSWIRE) -- The "Data Integrity and Document Management (June 22, 2026)" training has been added to ResearchAndMarkets.com's offering.
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, including 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.
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 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.
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:
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.
Key Topics Covered:
CPD Hours: 6
Speakers
Laura Brown
Dr Laura Brown MBA, BSc, PhD, is a pharmaceutical QA and training consultant and Senior Lecturer for the MSc in Clinical Research at the School of Pharmacy,University of Cardiff. She has more than 20 years' experience of quality assurance in the pharmaceutical industry and has worked for several companies, including GSK, Hoechst Marion Roussel, Farmitalia and Phoenix International.
Laura has a particular expertise in quality assurance including risk-based approaches to quality systems, data integrity and quality project management implementation in the pharmaceutical industry. She was Chair of the ACRPI GCP Forum for six years and regularly writes on pharmaceutical regulatory and quality issues including for the Research Quality Assurance Association's journal.
For more information about this training visit https://www.researchandmarkets.com/r/uq9zr8
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