Your company cannot operate without a level of reliance on computer 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 computer systems. As such, you must apply an appropriate level of risk-focused validation effort for your computer 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 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 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
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 will be delivered as an online virtual-classroom training session.
Participants will be provided with a PDF of the training material in advance of the training should they wish to print and annotate notes. Participants will be connected to the trainer and other participants via online collaboration tool Zoom with connected video (webcam / screen sharing) and audio (computer audio or phone dial-in). Theory will be delivered by the trainer sharing their screen of the PowerPoint presentation. Facilitated workshops will be run in digital breakout rooms (e.g. a group of 12 might split into 4 breakout rooms each with 3 participants to separately work on a problem). Breakout rooms can call the trainer in for support when required and the trainer can electronically bring everyone back to the main session to debrief when appropriate.
The training will be delivered as 2 x 3.5 hour sessions over 2 days. Breaks are included.
PDF Certificates will be provided to participants electronically.
What Do I Need?
Participant needs are very basic. You will need a computer or suitable device with a good internet connection. A headset (headphones with microphone) and second monitor/screen are recommended but not required.
Sessions
Participants will attend both half-day sessions:
| Sessions | Dates | Times |
| Day 1 | 16th August 2021 | 8:45am join for 9:00am-12:30pm |
| Day 2 | 17th August 2021 | 8:45am join for 9:00am-12:30pm |
Times are based on Melbourne, Australian Eastern Standard Time (AEST) / Coordinated Universal Time (UTC) +10:00.
Participants to join at 8:45am in advance of a 9:00am start to address any technical issues.
Fee and Discount
- AUD $600 (exc. GST) per participant
- A 10% discount applies for 3 or more participants from the same company
Contact us to discuss your interest in a public or private delivery of this course.
