Objectives

Through this course you will develop an understanding of:

• Common terms and definitions of Computer Systems Validation
• Types of, and elements of System Development Life Cycles (SDLC)
• Good Automated Manufacturing Practices (GAMP)
• What is critical for data integrity in the eyes of GxP regulators
• How computer systems are regulated in PIC/S (e.g. TGA and Medsafe) and FDA environments
• How to implement a CSA approach through worked examples
• How to recognise the compliance, risk and regulatory consequences of using computer systems

Content

See "Modules" tab

Participants

You will benefit from this course if you are a key Quality, IT or Operational Subject Matter Expert (SME) or Manager likely to be involved in using, validating, approving or purchasing computer systems.

Format and Course Length

The course is entirely online and on-demand built with a number of modules (i.e. topics) containing various content sections. Training content is primarily microlearning videos with audio (~3.5 hours total, where the trainer speaks to a PowerPoint presentation) accompanied by documents, images, weblinks and questions.

There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.

A digital credential (badge) will be issued from Credly on e-mail after the quiz assessment is passed.

Your licence grants you access to the course for 30 days.

What Do I Need?

Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset may be useful if you undertake this course in a shared environment due to the audio.

Workshops

This CSV on-demand course is a pre-curser to optional live instructor-led workshops that you may also be interested in participating in and you can register via the links here:

1. CSV Workshop (#1) Regulations (~ 1 hour)
   • We’ll discuss the FDA Environment, 21 CFR Part 11 and PIC/S Annex 11 and use this to explore areas of control within your company. We will then discuss specific Annex 11 clauses relevant to your requirements.
2. CSV Workshop (#2) CSVMP and Infrastructure Qualification (~1 hour)
   
   • We’ll walk through both a Computer System Validation Master Plan and an Infrastructure Qualification Plan to highlight the importance of the overarching validation framework.
3. CSV Workshop (#3) Risk Assessment and Practical Validation (~2 hours)
   • We'll work through a macro risk assessment, then use that risk assessment to discuss a CSA validation approach. We will then work through a full project validation example focussing on the validation plan, requirements, design and testing. This will highlight how knowledge gained at the system testing can flow back into the end-user testing.

Refer to the Terms and Conditions.

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