Auditing Computerised Systems

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Programme
Extra information

Course Information

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

Course Tutors

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

Keith Thornley
Regional CSQA Representative, Eli Lilly & Co Ltd

Recent Feedback

"Both [tutors] were very friendly and helpful and between them had a lot of knowledge on systems."

Course Programme

Please note timings are subject to alteration

	Day 1
12.30	Lunch
13.15	Registration
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
15.00	Break
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
	Day 2
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
10.45	Break
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
12.30	Lunch
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
15.00	Break
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
	Day 3
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
10.15	Break
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
12.30	Lunch
13.15	Workshop 4 Feedback
13.30	Infrastructure Qualification Comparison of Qualification and Validation
14.00	Different Challenges New technologies and new concerns for managing them
14.45	Break
15.00	Course Objectives Summary and Panel Discussion A round up of key learning from the course
15.30	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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