
Manufacturing Operations
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
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Understand the current regulatory focus on Data Integrity
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Understand the recent regulatory guidance on Data Integrity
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Meet the international regulatory requirements for records and signature
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Meet the requirements of other relevant regulations including EU Annex 11
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Maintain data integrity through the operation phase of the GAMP life cycle
Course Outline
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Data Integrity
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5W and 1 H of Data integrity
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Data in manual and Electronic form
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FDA
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MHRA
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WHO
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PIC/S Guidelines
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Data integrity examples and warning letters issued to companies.
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What is 21 CFR 11
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Myth of 21 CFR 11
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How it is applied into our system
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Paper records/ electronic records
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FDA 21 CFR 11 inspection questions
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Computerised systems
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Personnel
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ValidationSystem
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Change control & SOPs