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About us
Auditing Computerised Systems
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:
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Discuss and develop ideas
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Solve specific problems
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Understand the vulnerabilities of computerised systems
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Learn how to create a compliance checklist
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Link system development with good business practice.
Is this course for you?
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Auditors
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Audit programme managers
- Individuals subject to audits.
Tutors
Tutors will be comprised of (click the photos for biographies):
Nichola Stevens
Nichola is the owner of and Principal Consultant at Nuncius Compliance Solutions Ltd. In this role Nichola helps companies improve overall IT Quality and achieve effective regulatory compliance by performing gap assessments, data integrity evaluations, supplier audits, etc., and proposing and overseeing prioritized remediation activities.
Previously Nichola was the Global Director of Computer System Validation at Alere (now part of Abbott). In this role Nichola was responsible for ensuring that Alere had, and applied, the necessary standards, processes and procedures to deliver high quality, validated computerized systems and to maintain those systems in a compliant manner. This included identifying and managing risks (e.g. cloud computing, outsourcing, data integrity, data center migrations, etc.) that might impact the GxP compliance of Alere’s computerised systems.
Nichola started her career in R&D as a chromatographer with SmithKline Beckman before moving to Oxford Asymmetry International, gaining a first experience of validation. Further experience was gained at Covance before Nichola joined Mi Services as a validation consultant. . Prior to joining Alere, Nichola worked for AstraZeneca as the Global GxP Subject Matter Expert within IT.
Nichola is the Chair of the GAMP UK Steering Committee, a member of the GMP Europe Steering Committee, and a member of the RQA IT Committee.
Barry McManus
Barry is a Principal Consultant for Empowerment Quality Engineering ltd, a Computerised System Validation consultancy that bridges the gap between IT and Quality.
Barry focuses on building quality and security into Computerised Systems (CS) by using quality techniques from the wider software industry while ensuring regulatory compliance. He leads GxP Computerised System (CS) Validation compliance and IT Supplier/Service Provider audits across the globe; performs IT supplier’s software lifecycle process improvement; risk assessments to drive Validation strategies and tailored training.
Barry has over 23 years’ experience in Software Engineering and IT Administration with vast technical knowledge of every role and every activity within the Computerised System lifecycle; development methodologies (traditional and agile), databases and programming languages across multiple technologies. He moved into the regulated industry in 2003 to commence management roles in QA, QC and CS validation. His approach resulted in delivering risk based, on time, right first-time CS validation projects. His experiences ensure that technical and regulatory risks do not compromise CS validation projects, delivers “value add” CS validation documentation and GxP compliance.
He is a member of the RQA’s I.T. committee, the DIA IQCT community core team and a member of the ISPE Data Integrity Project team.
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
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.
Free Booklet
All delegates will receive a copy of our booklet 'Auditing Computerised Systems'.
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.
Free Booklet
All delegates will receive a copy of our booklet 'Auditing Computerised Systems'.
Development Level
Develop
Recommended Products
Auditing Computerised Systems eBooklet
Computerised System Validation eBooklet