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Manufacturing Operations


Manufacturing Operations 


Data Integrity 21 CFR Part 11

Data Integrity 21 CFR Part 11

Duration (Days)



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.

  • 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

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