Data Integrity Overview

Overview of Data integrity History & Requirements for GMP

This course offers a high-level introduction to the principals of Data integrity for GMP manufacturers.

Learn about the history, background, origins and inspection focus for this complex topic.

Ideal for:

  • Senior Management
  • Quality Assurance
  • Data & System owners


Approximate Duration:  45mins

Key Learnings

  • Data Integrity History

    Understand the historical context for Data Integrity Requirements

  • Data Integrity Requirements

    Understand the requirements for Data integrity compliance

  • Data Integrity Inspection Focus

    Understand the regulatory inspection focus for Data Integrity

Course curriculum

  • 1

    Course Introduction

    • Course Introduction
  • 2

    Data Integrity Background & History

    • Data Integrity Definition

    • Data Integrity History

    • Data Integrity Risks

    • Data Integrity Guidance & Governance
  • 3

    Data Integrity Motivations & Causes

    • Data Integrity Causes & Motivations
  • 4

    Data Integrity Areas of Focus

    • Data Integrity- Areas of Inspection Focus

    • Data Integrity and R&D

    • Non-GxP Data and For Information Only data
  • 5

    Data Integrity Example Deficiencies

    • Data integrity- Example Deficiencies
  • 6

    Conclusions & Quiz

    • Conclusions

    • Course Slides

    • Untitled quiz

Instructor(s)

Instructor

Ian Ramsay

Ian Ramsay is an ex-MHRA GMDP inspector who established RamsayPharma consulting in 2016 to support industry with quality and compliance needs. Ian Ramsay has extensive experience in the Pharmaceutical Industry across a wide range of dose forms and processes. A microbiologist with experience in Pharma and GMP/GDP Regulatory inspections, Ian can bring a wealth of knowledge to your organisation. As an accredited LMLS (leading & managing lean sigma) Green Belt, Ian can bring a balanced and pragmatic approach to Quality and Compliance to your quality and compliance needs.