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."
Please note timings are subject to alteration
||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|
Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course.
The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions.
You will also receive a copy of our booklet - "Auditing Computerised Systems"
Where the venue is Madingley Hall, accommodation and dinner are available for the dates of the course (we recommend you take this as the location has few nearby facilities).
If you wish to book additional dates please specify in the ‘accommodation requirements’ box when making your booking and we will check availability with Madingley Hall. Bed and Breakfast is £77*, dinner (three courses with drinks, in the main dining room with other course participants) is £35* (* per night per person) - these can be selected during the booking process. As part of the booking process we ask for dietary requirements and these will be taken in to consideration by Madingley Hall. Alternatively bar snacks are available on a pay as you go basis, not bookable through RQA.
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P08 The Auditing Course
P34 Practical Approach to Auditing Systems and Processes
P41 Advanced Auditing Skills: Audit Planning and Performance
P42 Advanced Auditing Skills: Audit Analysis and Reporting
RP01 Introduction to Computer Systems Validation REMOTE LEARNING