Auditing Computerised Systems

Description

Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP).

Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation.

Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course.

Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance.

Tutors will be comprised of (click the photos for biographies):

Director and Principal Consultant, Nuncius Compliance Solutions Ltd

Consultancy Partner, Empowerment Quality Engineering Ltd

Please note timings may be subject to alteration.

Welcome and Introductions

Why We Validate and Regulatory Trends

Break

Audit Overview, High Level Process and Scheduling

System Lifecycle

Lunch

Exercise 1 - Audit Scheduling

Exercise 1 - Feedback

Break

Validation Deliverables

Risk Assessments

Close of Day 1

Supplier Assessment

Break

Exercise 2 - Planning a Supplier Audit

Exercise 2 - Feedback

Lunch

Exercise 3 - Auditing a Computerised System Validation Package

Break

Exercise 3 - Feedback

Change Control

Close of Day

Infrastructure Qualification

Maintaining a Validated State - Operational Processes

Break

Exercise 4 - Auditing Systems in Operational Use

Lunch

Exercise 4 - Feedback

Exercise 5 - Auditing Trail Review

Break

Exercise 5 - Feedback

Course Objectives Summary and Any Additional Questions

Close of Course

Face-to-face course

Course material will be available in PDF format for delegates attending this course. The advantages of this include:

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.

Remote course

This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event.

Please note this course will run in UK timezone.

You will need a stable internet connection, a microphone and a webcam.

19 Points

Develop