This two and a half day course offers the ideal external training opportunity for auditors, those who manage audit programmes and those who will be audited, to develop the understanding and skills necessary for auditing the validation of computer systems intended for use in GxP (GLP, GCP, GMP, GDP, GPvP) environments.
The course starts with an introduction to the regulatory requirements and the system life cycle and then concentrates on the practicalities of computer system validation audit.
The course provides a mixture of presentations, discussions and practical workshops.
Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance
* apply risk management techniques to audit planning
* plan and conduct computerised system audits
* assess system validation documentation to verify compliance
* evaluate data integrity and security issues
* prepare for regulatory inspection
The course is structured to encourage delegates to
* discuss and develop ideas
* solve specific problems
* understand the vulnerabilities of computerised systems
* learn how to create a compliance checklist
* link system development with good business practice
Director and Principal Consultant, Nuncius Compliance (Course Principal)
Regional CSQA Representative, Eli Lilly & Co Ltd
"Both [tutors] were very friendly and helpful and between them had a lot of knowledge on systems."
Please note timings are subject to alteration
|13.30||Welcome, Introductions and Course Objectives|
|14.15|| Regulation and Regulatory Compliance
The importance of quality and regulatory requirements and expectations for computerised systems
|15.15|| Regulatory Trends and Inspection Readiness
A review of recent regulatory inspection finding and a discussion of effective preparation for inspection
|16.30|| The System Life Cycle
The concept of the SLC and the key outputs from it
|17.15|| Questions and Answers
Answers to any outstanding questions from Day 1
|17.30||Close of day|
|09.00|| Auditing Computerised Systems - High Level Process
Types, scope, objectives, standards, planning, preparation and reporting of computerised system audits
|09.45|| Risk Management
Risk management and its impact on validation. Identifying the deliverables required. Then exercise on risk assessment for 3 systems
|11.00|| Validation Deliverables
The concept of the Validation process and the key outputs from it. Exercise on validation deliverable based on risk.
|12.00|| Project Introduction
The system which will be the object of the project is described and processes and deliverables are explained
|13.15|| Workshop 1 - Vendor Audit
Planning a vendor audit with a focus on the key validation deliverables
|14.00|| Workshop 1 Feedback
and model answers
|14.15|| Workshop 2 - CSV Audit
CSV Audit - planning your audit then performing the audit of the validation components
|15.15||Workshop 2 - CSV Audit (continued)|
|16.15|| Workshop 2 Feedback
CSV Audit - feedback
|16.45|| Change Control
Change control and ongoing system quality post implementation
|17.30|| Questions and Answers
Answers to any outstanding questions from Day 2
|17.45||Close of day|
|09.00|| Workshop 3 - Auditing Systems in Operational Use
Auditing Systems in Operational Use (SOPs exercise)
Planning and execution of audits of systems in operational use. What to look for
|10.30|| Workshop 3 Feedback
and model answers
|11.00|| The Principles of Data Integrity
Integrity, security, intellectual property, contingency and continuity planning
|11.45|| Workshop 4 - Audit Trail Review exercise
Current regulatory guidance and best business practice for ensuring continued access to data
|13.15||Workshop 4 Feedback|
Comparison of Qualification and Validation
New technologies and new concerns for managing them
|15.00|| Course Objectives Summary and Panel Discussion
A round up of key learning from the course
|15.30||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.