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HES6411 Computer Systems Validation (3 days)

Aims and Objectives

This subject aims to introduce students to the necessity for validation in IT and to train students for the need to be prepared for auditing etc. in the real world.

On completion of this subject students will be able to:

• Understand the requirements of the regulations and how they relate to the guidance documents and Good Automated Manufacturing Practices (GAMP).
• Understand all stages of the software development lifecycle and their related documentation.
• Understand supplier audit concepts and the importance of the user/supplier relationship.
• Learn the concepts of risk assessment.
• Understand the QA & IT terminology.
• Identify the requirements of computer system suppliers to the industry.
• Discuss relevant case studies and participate in workshops on all aspects of computer validation.

Content

• Principles of Computer Validation.
• Understanding the GAMP Approach to Computer Systems Validation (CSV).
• Electronic Records and Electronic Signatures.
• CSV Documentation and Testing.
• Current regulatory Trends / Requirements.
• Introduction to GxP issues in relation to computer system usage.
• Supplying to the pharmaceutical industry.

Format

The course consists of a lively mix of presentations, group exercises, and discussions. At the end of the course, there will be a short quiz to test understanding. Copies of all presentation slides and handouts will be provided.

Out of Class Assignment

Participants are offered the opportunity to complete a GMP assignment following completion of the course. This will be facilitated and supported remotely by SeerPharma's team of consultants, and successful completion will be rewarded with additional certification.

There is no additional charge for this.