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Event Details


Data Integrity for GxP Compliance

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Who should attend?

This course is designed for managers and staff from clinical research and other GXP areas in the pharmaceutical and medical device industries who are responsible for the creation, review, approval and reporting of data to ensure Data Integrity, including, Clinical Trials, Manufacturing, Pharmacovigilance, QC/QA and QA personnel from CROs and CMOs. GXP auditors responsible for carrying out audits and self-inspections or external audits will also benefit from this course. Relevant roles include those working in: Clinical research Regulatory affairs Quality assurance / quality control Legal and compliance office Compliance manager GMP compliance officers Heads of internal audits


Course Overview

Topics to be covered Include:

  • Understand the importance of data integrity
  • Discuss data integrity criteria and definitions – eg ALCOA
  • Be aware of key regulations and guidelines – MHRA / FDA/ EMA / PICS / ICH GCP R2
  • Understand QMS considerations for data integrity
  • Review data integrity inspection findings to check for compliance against data integrity expectations
  • Consider the requirements for data integrity governance to prevent data integrity breaches

Why you should attend

Data Integrity is now a focus for regulatory inspections, with both EU and FDA inspectors increasingly observing violations during GxP inspections. Data Integrity 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 ensure the safety, efficacy, and quality of drugs. Data integrity-related violations 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 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 practical advice in defining and implementing an appropriate data governance process for compliance with data integrity requirements.




Leigh White

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