Data Integrity and Document Management Training Course: Latest MHRA Data Integrity Guide and EMA TMF Guidelines (April 21, 2023)
DUBLIN, Oct. 18, 2022 /PRNewswire/ -- The "Data Integrity and Document Management Training Course" conference has been added to ResearchAndMarkets.com's 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, 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.
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:
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:
Data integrity regulations and guidelines
Document management and data integrity inspection findings
QMS considerations for Data integrity and documentation
Data integrity for computer systems
Discussion of document and data integrity issues
She has a particular expertise in quality assurance including risked based approaches to quality systems, data Integrity and project management in the pharmaceutical industry. She regularly writes on pharmaceutical regulatory issues including "The Planning of International Drug Development", in the Clinical Research Manual, Euromed and the "Impact of Brexit", RQA Journal 2017.
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