Booking options
£1,139 - £1,527
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Auditing Computerised Systems
- 30 Day Money Back Guarantee
- Completion Certificate
- 24/7 Technical Support
Highlights
Delivered In-Person
3 days
Description
Course Information
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.
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.
Is this course for you?
Auditors
Audit programme managers
Individuals subject to audits.
Tutors
Tutors will be comprised of (click the photos for biographies):
Nichola Stevens
Director and Principal Consultant, Nuncius Compliance Solutions Ltd
Barry McManus
Consultancy Partner, Empowerment Quality Engineering Ltd
Programme
Please note timings may be subject to alteration.
Day 1
09:00
Welcome and Introductions
09:45
Why We Validate and Regulatory Trends
10:30
Break
10:45
Audit Overview, High Level Process and Scheduling
11:30
System Lifecycle
12:30
Lunch
13:15
Exercise 1 - Audit Scheduling
14:45
Exercise 1 - Feedback
15:15
Break
15:30
Validation Deliverables
16:30
Risk Assessments
17:30
Close of Day 1
Day 2
09:00
Supplier Assessment
10:30
Break
10:45
Exercise 2 - Planning a Supplier Audit
12:00
Exercise 2 - Feedback
12:30
Lunch
13:15
Exercise 3 - Auditing a Computerised System Validation Package
15:30
Break
15:45
Exercise 3 - Feedback
16:30
Change Control
17:15
Close of Day
Day 3
09:00
Infrastructure Qualification
09:45
Maintaining a Validated State - Operational Processes
11:00
Break
11:15
Exercise 4 - Auditing Systems in Operational Use
12:45
Lunch
13:30
Exercise 4 - Feedback
14:15
Exercise 5 - Auditing Trail Review
15:30
Break
15:45
Exercise 5 - Feedback
16:15
Course Objectives Summary and Any Additional Questions
16:45
Close of Course
Extra Information
Face-to-face course
Course Material
Course material will be available 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.
Remote course
Course Material
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.
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 Access to an online course group to enhance networking.
You will need a stable internet connection, a microphone and a webcam.
CPD Points
19 Points
Development Level
Develop
Dates
- Delivered OnlineFrom:To:£1,139 - £1,527
Location
Radisson Blu, Manchester Airport Chicago Avenue, M90 3RA, United Kingdom, ManchesterAbout The Provider
Research Quality Association
Ipswich
RQA (Research Quality Association) is the global community for QA professionals, providing invaluable information, education, and networking opportunities
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