This course will provide you with an overview of what matters in Computerised System Validation (CSV) - including Computer Software Assurance (CSA) - to help your company meet regulatory requirements and mitigate risks to product quality and patient safety.
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
Topics/Modules
- Course Introduction
- 2 sections
- Introduction to CSV
- 12 sections
- Validation Concepts
- 16 sections
- Validation Planning and Execution
- 14 sections
- Audits and Vendor Management
- 5 sections
- Requirements to Release and Report
- 24 sections
- After Release and Beyond
- 15 sections
- 21CFR Part 11
- 10 sections
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.
Assessment / Certificate
There is a 10-question quiz assessment at the end of the course with a pass mark of 80% and 3 attempts.
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 a mix of video (with audio where the trainer speaks to a PowerPoint presentation), documents, images, weblinks and quizzes.
Available 24/7, you can undertake the training at any time and over multiple sessions as you need; the Matrix Learning Management System (LMS) will save your progress so you can continue in the next session from wherever you're up to. The training is self-paced, so you can progress as quickly or slowly as you need. The course includes ~3.5 hours of videos (as microlearning) as well as reference documents, in-learning quizzes and a final assessment. Your licence grants you access to the course for 30 days.
This CSV on-demand course is a pre-curser to optional live instructor-led workshops that you may also be interested in >> Learn more
Access
For organisations looking to setup once-off or ongoing training for group of personnel, SeerPharma can create a dedicated company account in our online Learning Management System (LMS) or we can licence courses for you to host in your own LMS or QMS. Request pricing for organisations.
For individuals, you can buy now for $299 (ex GST) and your licence grants you access to the course for 30 days.
Contact us with any questions.
