Computer Systems for Regulated Environments and Data Integrity

Course Code: CPD/O/09/2021

CPD Hours: 14

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. This course will provide you with an understanding of what matters in validation of computerised systems to help your company meet regulatory requirements and mitigate risks to product quality and patient safety.

Content

Day 1

 Regulations and GAMP

• Definition of validation as applied to computerised systems
• Regulatory status and PIC/S
• Introduction to the Principles of CSV
• GAMP

• System Life Cycle Approaches
• Development Models
• More Principles of CSV
• Mapping into Company Procedures
• Data Integrity
• Risk Assessment for Computerised Systems

• IT Infrastructure Qualification / Validation
• Validation Master Planning
• Legacy System Validation
• Generating an Inventory of Systems
• Validation Protocol
• Spreadsheet Validation
• Validation Plan
• Cross Functional Plans

Day 2

• Requirements Definition
• Traceability
• Audits
• Design

• Coding
• Testing
• Qualification
• Use
• Decommissioning

• Detailed interpretation of Part 11
• Implications for computerised systems in applying Electronic Records and Signatures
• Applying principles to new and existing Systems
• Reviewing Example Scenarios
• Understand Cloud Computing Implications

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 full day sessions with breaks.

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 full-day sessions.

Seats are limited: Only 25 participants per class

Fee and Registration

• HKD $4320 per participant

To register, please contact Biju Kishor at Biju.kishor@seerpharma.com.au 

Refer to the Terms and Conditions