Your company cannot operate without a level of reliance on computerised systems. New technology and the industry hot topic “data integrity” (“information availability, authenticity, correctness and traceability”) are driving greater adoption of computerised information systems.
In response, regulators like the TGA, FDA and Medsafe are increasingly scrutinising the validation of computerised systems. As such, you must apply an appropriate level of risk-focused validation effort for your computerised systems and organisation to be compliant.
The Computer Software Assurance (CSA) approach is being widely discussed for its use of critical thinking and risk assessment.
This course will provide you with an overview of what matters in validation of computerised systems (including CSA) to help your company effectively and efficiently ensure systems are fit for purpose, meet regulatory requirements and mitigate risks to product quality and patient safety.
Content
Through this course you will develop an understanding of:
- Common terms and definitions of Computerised 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 computerised 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 computerised systems
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 computerised systems.
Training Delivery Options
- Online and On-Demand for Anyone, Anywhere, Anytime
- Contact us to discuss your interest in a private delivery of this course, which can be either online (Zoom) or on-site.
Certificate
