This two and a half day course is the ideal external training opportunity for people needing to gain a basic understanding of computerised system validation. The knowledge gained will help attendees to validate systems within their own organisation for use in GxP (GLP, GCP, GMP, GDP and GPvP) environments, and to audit validated computerised systems to assure compliance with the applicable GxP regulations.
The course starts with an introduction to the regulatory requirements and the system lifecycle and then concentrates on the practicalities of validating computerised systems and auditing these systems.
The course provides a mixture of presentations, discussions and practical workshops.
This course will provide delegates with an understanding of the computerised system validation process, including:
Who should attend
Tutors will be comprised from the list below:
Director and Principal Consultant, Nuncius Compliance (Course Principal)
Consultancy Partner, Empowerment Quality Engineering Ltd
"Huge amount was provided and in details for an introductory course."
"I liked Barry that used schemes to explain the unimaginable IT part. Very helpful during the exercise and quite open to share ideas and suggestions."
||Welcome, Introduction and Expectation Setting|
|13.30||Why Validate? Regulations and Guidance on Computerised System Validation|
|14.00||Overview of lifecycle and user requirements|
Exercise 1 - User Requirements
|17.20||Day 1 Summary and Q&A|
|17.30||Close of day|
|10.00||Exercise 2 - Supplier Assessment|
|12.00||Test Overview and Test Planning|
|13.45||Test Overview and Test Planning (continued)|
|14.15||Test Script Design and Execution|
|15.45||Test Script Design and Execution (continued)|
|16.15||Infrastructure Configuration and Qualification|
|17.00||Day 2 Summary, Q&A and close of day|
|09.00||Exercise 3 - Test Script Design|
|11.15||Maintaining the Validated State|
|14.15||Excel Spreadsheet Validation|
|15.15||Course wrap up and check expectations met|
|15.45||Close of course|
This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.
You will need a stable internet connection, a microphone and a webcam.
P01 Introduction to Computer Systems Validation
P04 Quality Assurance for Good Laboratory Practice
P08 The Auditing Course
P34 Practical Approach to Auditing Systems and Processes
P42 Advanced Auditing Skills: Audit Analysis and Reporting
RP04 Quality Assurance for Good Laboratory Practice REMOTE LEARNING
RP09 The REMOTE Auditing Course
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