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Data Integrity 21 CFR Part 11

Data Integrity 21 CFR Part 11

Duration (Days)

2

Overview

This course is designed to help participants to understand the GMP Data Integrity for pharmaceutical manufacturing compliance. The authorities such as MHRA , FDA , PIC/S and TGA which has been published more guidance documentation on data management / data integrity. Participants will learn the new guidelines and how to implement it in workplace.

Objectives
  • Understand the current regulatory focus on Data Integrity

  • Understand the recent regulatory guidance on Data Integrity

  • Meet the international regulatory requirements for records and signature

  • Meet the requirements of other relevant regulations including EU Annex 11

  • Maintain data integrity through the operation phase of the GAMP life cycle

Course Outline
  • Data Integrity

  • 5W and 1 H of Data integrity

  • Data in manual and Electronic form

  • FDA

  • MHRA

  • WHO

  • PIC/S Guidelines

  • Data integrity examples and warning letters issued to companies.

  • What is 21 CFR 11

  • Myth of 21 CFR 11

  • How it is applied into our system

  • Paper records/ electronic records

  • FDA 21 CFR 11 inspection questions

  • Computerised systems

  • Personnel

  • ValidationSystem

  • Change control & SOPs