For Madingley Hall courses, if you wish to stay for additional nights or double occupancy, please contact the us - firstname.lastname@example.org in the first instance
This three 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
|09:00||Welcome, Introduction and Course Objectives|
|09:45|| Why Validate? Regulations and Guidance on Computerised System Validation
Overview of the regulations and guidance applicable to CSV and their key expectations
|10:45|| The System Lifecyle
The concept of the SLC and the key outputs from it
|12:45|| The Validation Process
The approach to validation for different system types and a look at some of the key deliverables
|14:15|| Exercise 1 - User Requirements
Capturing, agreeing and documenting the user requirements for a system
|15:30||Exercise 1 - feedback|
|16:00|| Risk Management
Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for 3 systems
|17:00|| Questions and Answers
Answers to any outstanding questions from Day 1
|17:15||Close of Day|
|09:00|| Supplier Assessment
The different approaches to supplier assessment and the things to be considered when assessing a supplier
|10:15|| Exercise 2 - Supplier Assessment
Planning a vendor audit with a focus on the key validation deliverables
|11:15||Exercise 2 - feedback|
|11:45|| Test Overview and Test Planning
The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing
|13:30|| Test Overview and Test Planning
|14:15|| Test Script Design, Execution and Review
What a good test script looks like and the key things to consider when creating, executing and reviewing a test script
|15:45|| Exercise 3 - Creating a Test Script
Create a test script based on user requirements created on Day 1
|17:15||Close of Day|
|09:00||Exercise 3 feedback|
|09:30||Infrastructure Configuration and Qualification|
|10:45|| Validation Reporting
Overview of the Validation Report and what should be included in it
|11:15|| Maintaining the Validated State
The procedures and records needed to ensure the system remains fit for purpose
|13:15|| Change Control
Key concepts related to making changes to validated systems
|14:00||Exercise 4 - Change Control|
|14:45||Exercise 4 - feedback|
|15:30|| Data Integrity and Security
How can we assure the integrity and security of our data
|16:45||Course Objective Summary and Panel Discussion|
|17:00||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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