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Introduction to Computer Systems Validation

 

RQA CPD Stamp

Course Information

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:

  • Definition of end user requirements
  • Risk management, including supplier assessment and techniques for audit planning
  • Validation planning and reporting
  • Linking system development with good business practices
  • Formal testing and qualification
  • Understanding of data integrity and security issues
  • How to assess system validation documentation to verify compliance

Who should attend

  • IT professionals new to implementing computerised systems into regulated environments
  • Quality professionals who monitor or audit computerised systems
  • System owners, end users, tester and project staff

Course Tutors

Tutors will be comprised from the list below:

Nichola Stevens
Director and Principal Consultant, Nuncius Compliance (Course Principal)

Barry McManus
Consultancy Partner, Empowerment Quality Engineering Ltd

Recent Feedback

"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."

CPD Points

19 Points

Course Programme

Please note timings are subject to alteration

 

Day 1 
11.45 Registration 
12.00
 Welcome, Introduction and Expectation Setting
12.45 Lunch
 13.30 Why Validate?  Regulations and Guidance on Computerised System Validation 
 14.00 Overview of lifecycle and user requirements
15.00 Break
15.15 Project Introduction
Exercise 1 - User Requirements
 16.30 Risk Management
17.20 Day 1 Summary and Q&A
17.30 Close of day
 

Day 2
9.00 Supplier Assessment
10.00 Exercise 2 - Supplier Assessment
10.45 Break
11.00 Validation Planning
 12.00 Test Overview and Test Planning
13.00 Lunch
13.45 Test Overview and Test Planning (continued)
 14.15 Test Script Design and Execution
15.15 Break
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
 

Day 3 
09.00 Exercise 3 - Test Script Design
10.00 Validation Reporting
10.45 Break
11.15 Maintaining the Validated State
 12.00 Change Control 
12.45 Lunch
 13.15 Data Integrity
 14.15 Excel Spreadsheet Validation
15.00 Break
15.15 Course wrap up and check expectations met
15.45 Close of course 

Course Material

Following requests from attendees of previous RQA events we are pleased to offer course material in PDF format for delegates attending this course. 

The advantages of this include

  • Ability for delegates to keep material on a mobile device
  • Ability to review material at any time pre and post course
  • Environmental benefits – less paper being used per 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"

Additional Requirements
(not included in course fees)

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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Booklets

Auditing Computerised Systems
Computerised System Validation
Management of the Training and Competency of Personnel in GxP and Research Environments

Courses

P04 Quality Assurance for Good Laboratory Practice
P08 The Auditing Course
P34 Practical Approach to Auditing Systems and Processes
P41 Advanced Auditing Skills: Audit Planning and Performance
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RP01 Introduction to Computer Systems Validation REMOTE LEARNING

Webcasts

Webcast - Where Does Audit End?

eLearning Products

Introduction to the Audit Process elearning

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