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Auditing Computerised Systems

By Research Quality Association

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

Auditing Computerised Systems
Delivered in Manchester or Online + more
£1297 to £1687

BRCGS Food Safety Issue 9 - Lead Auditor (5 Days)

5.0(6)

By Ask Sonia Limited

Official BRCGS Food Safety Issue 9 Lead Auditor training course. Delivered online (Zoom) by a live BRCGS Approved Training Partner & Virtual Trainer. Exam and Certificate fee included in the price.

BRCGS Food Safety Issue 9 - Lead Auditor (5 Days)
Delivered Online + more
£975

BRCGS Storage & Distribution Auditor Issue 4 (3 Days)

5.0(36)

By Ask Sonia Limited

Official BRCGS Storage & Distribution Issue 4: Auditor course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

BRCGS Storage & Distribution Auditor Issue 4 (3 Days)
Delivered Online + more
£840

BRCGS Food Safety Issue 9 - For Auditors (3 Days)

5.0(37)

By Ask Sonia Limited

Official BRCGS Food Safety Issue 9 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

BRCGS Food Safety Issue 9 - For Auditors (3 Days)
Delivered Online + more
£800

BRCGS Food Safety Issue 9 - For Sites (2 Days)

5.0(2)

By Ask Sonia Limited

Official BRCGS Food Safety Issue 9 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

BRCGS Food Safety Issue 9 - For Sites (2 Days)
Delivered Online + more
£570

BRCGS Storage & Distribution Sites Issue 4 (2 Days)

5.0(36)

By Ask Sonia Limited

Official BRCGS Storage & Distribution Issue 4: Sites course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

BRCGS Storage & Distribution Sites Issue 4 (2 Days)
Delivered Online + more
£570

Become A Mental Health First Aider

By Starling

Embark on a transformative journey to become a qualified MHFAider®. Master your skills and learn how to spot and support people with mental health issues and make a difference whether at work, volunteering, or in your community.

Become A Mental Health First Aider
Delivered Online + more
£315

Watercolour for All 4 week Online Course Monday Morning Via Zoom

By Art By Purnima

Watercolour for All 4 week Online Course Monday Morning Via Zoom

Watercolour for All 4 week Online Course Monday Morning Via Zoom
Delivered Online + more
£95

IPAF - Harness Awareness

By Kingfisher Access

The theory assessment provides delegates with the essential knowledge to select, monitor, manage and plan the correct use of Harnesses and lanyards for use in a MEWP. Delegates successfully completing the e-learning will: Have an awareness of how to correctly identify and select the appropriate form of personal protection against falls from MEWPs. Have a theoretical awareness only of how to check, use, maintain and store a harness and lanyard with manufacturer’s instructions. Have a theoretical awareness of how harnesses and lanyards should be fitted and adjusted.

IPAF - Harness Awareness
Delivered Online + more
£75

Ear Irrigation Training

4.9(1007)

By Caring For Care

Anatomy and physiology How to examine the ear About this event Anatomy and physiology How to examine the ear Common ear problems & foreign bodies Complications Risk assessing Infection control Documentation and record keeping Ear irrigation (syringing) Practical session

Ear Irrigation Training
Delivered in Stoke On Trent or Online + more
£170