Data Integrity and Document Management Training Course: Ensure Compliance with Latest Data Integrity Guidelines (ONLINE EVENT: July 14, 2025) - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Data Integrity and Document Management Training Course" has been added to ResearchAndMarkets.com's offering.

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.

Document management and data integrity have become focal points during regulatory

inspections by both EU and FDA authorities, with a notable increase in violation observations in GxP inspections. This highlights the critical nature of document governance. Regulatory bodies mandate that individuals in GxP roles be well-versed in this area, underscoring its significance in maintaining drug safety, efficacy, and quality.

Recent regulatory actions, including warning letters and critical inspection findings, have often stemmed from breaches in document management and data integrity. As a response, the FDA, EMA, MHRA, and the World Health Organization (WHO) have released new guidelines aimed at fortifying data integrity within the pharma sector.

This comprehensive course delves into the imperatives of data integrity, highlighting its impacts on both paper-based and digital systems. Participants will engage with the latest MHRA data integrity and EMA TMF guidelines crucial for any entity engaged in the GxP pharmaceutical lifecycle, covering facets of GCP, GMP, GLP, and GvP.

Attendees will gain insights into ensuring compliance with data integrity standards. The program offers a detailed review of data integrity inspection findings and provides hands-on advice on setting up a robust data governance process to meet compliance demands.

Benefits of Attending:

• Grasp the significance of data integrity and best practices in document management.
• Achieve compliance with the new EU trial master file (TMF) guideline.
• Stay informed about pivotal regulations and directives.
• Deliberate on QMS considerations related to data integrity and document management.
• Explore inspection outcomes on document management and data integrity for better regulatory compliance.
• Understand governance requirements to avert data integrity breaches effectively.
• This course is part of the GxP training collection, covering various topics to maintain adherence to regulatory and quality standards.

Certification:

• CPD: Earn 6 hours towards your professional development records.
• Receive a certificate of completion upon the course's conclusion.

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

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

• Elements of QMS for data integrity
• Risk management considerations
• Data governance
• Discussion of participants experience and best practice

Data integrity for computer systems

• Computer system validation considerations
• Compliance expectations 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 https://www.researchandmarkets.com/r/hj86ci

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