Course overview
Our fully interactive Software Validation training course provides attendees with the knowledge and skills they need to comply with European, US and Worldwide software validation requirements.
The course is fully tutor-led and focuses on the practical implementation of software validation requirements. The course provides attendees with a well-thought-out approach and real-world implementation methodologies, to help achieve compliance and assure consistency of performance of computerised systems. The course addresses the use of software and computerised systems in QMS, production, testing and distribution. Risk Management of software and computerised systems, and scaling of validation effort in proportion to risk, are covered in detail.
The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Data Integrity. The course involves practical group exercises which take the learner through the entire validation cycle with comprehensive feedback from the course tutor throughout.
What you'll learn
Upon completion of this course, participants will be able to;
- Identify the regulatory requirements for software validation,
- State the benefits of conducting software validation,
- Categorise software in accordance with GAMP guidelines,
- Apply the V Model to software validation,
- Appreciate European and FDA Guidance publications on software validation,
- Design a software validation master plan,
- Write user requirements for software and computerised systems,
- Assess software and computerised systems risks,
- Identify the main requirements for Electronic Records and Electronic Signatures,
- Apply the FDA guidance on 21 CFR Part 11 to software systems,
- State the main Data Integrity requirements,
- Complete a software DQ,
- Write IQ test cases for computerised systems,
- Identify challenge tests for software systems,
- Write Software OQ test cases,
- Write Software PQ test cases,
- Report on Software testing results,
- Leverage vendor documentation to minimise validation effort,
- Assist in ensuring that the validated state is maintained.
Study method
- In-class
- Virtual
- Blended
- Online
Duration study load
- 3 training days
Testimonials
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Yasser A"The course provided a comprehensive overview of software validation principles. - Mr. John delivered the course with great expertise and professionalism."
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Jakub S" am very happy and satisfied I took this course. Profesionalism of the tutor, quality of materials - one of the best courses I've had so far."
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Rob F"Helpful, applicable content, taught well by a very knowledgeable tutor."
Who's it for?
Personnel in the Pharmaceutical/Medical Device/Healthcare sectors who need to gain a solid practical foundation in how to perform Computer Systems and Software Validation in a regulated environment.
Delivery
This programme is delivered by Classroom, Virtual Training, or In-Company training
How do we train and support you?
In-House Courses
Course tutor will contact your organisation in advance to discuss the programme in detail.
In-house courses can be customised to meet your organisation’s specific requirements.
Course Manual
Delegates will receive a hardcopy course manual with relevant course materials.
Abbreviations used in this document:
- CPD: Continuous Professional Development
- DQ: Design Qualification
- GAMP: Good Automated Manufacturing Practice
- IQ: Installation Qualification
- MVP: Master Validation Plan
- OQ: Operational Qualification
- Part 11: 21 CFR Part 11 Electronic Records and Electronic Signatures
- PQ: Performance Qualification
- RTM: Requirements Traceability Matrix
- URS: User Requirements Specification
Subjects
- The Need for Software Validation
- European and FDA Regulations and Guidance on Software Validation
- Software Validation Regulations interactive quiz – New
- The latest FDA Guidance on Software Validation – New
- Group Discussion the latest FDA Guidance on software validation – New
- The GAMP Approach to Software Validation
- GAMP Categorization case study – New
- The V Model Approach
- V Model Approach interactive exercise
- Software Validation Planning – designing master validation plans
- Writing Software Validation Rationales – New
- Case Study – determining what needs to be included in the MVP for a specific manufacturing process – New Content
- Requirements Specifications – Case Study writing a URS
- Application of Risk Analysis to Software – Updated Content
- Software Design Qualification
- Requirements Tracing – using the RTM to plan qualification testing
- Case Study – writing an equipment IQ Protocol
- Software Testing and Software Test Environments
- Software Testing Interactive Exercise
- Case Study – writing an equipment OQ Protocol
- Application of Statistics to Software Validation – New Content
- Statistical Rationale for Samples Sizes – Updated Content
- Electronic Records and Electronic Signatures
- 21 CFR Part 11 Interactive Exercise
- Application of the FDA Guidance on Part 11
- Data Integrity and Software Validation – New
- Software Performance Qualification
- Case Study – writing a Software PQ Protocol – Updated Content
- Leveraging Supplier documentation for off-the-shelf systems – Updated Content
- Validation Reporting – How to Report on Software Validation testing – New
- Maintaining the Validated State – Updated Content
- End of Course Assessment. – New
About SQT Training
We are a specialist provider of bespoke training programmes that help organisations become leaner, more compliant and more progressive. For over 30 years, we’ve brought the latest thinking, the leading techniques and the most experienced industry experts into ambitious organisations, large and small, throughout Ireland, the UK, and beyond.
We trained some of the very first ISO Lead Auditors, and many years ago, we coached the earliest adopters of Lean Six Sigma.
We empower people with the capability to help their organisations reach the highest standards, maintain compliance, and drive efficiency.
Our programmes are renowned for their dynamic, practical, real-world approach and are built on a foundation of theory and practice that works. That’s why the likes of CRH, eBay, Glanbia, Kerry Group, Medtronic, Musgraves and Pepsi trust us to train their people – over 65,000 in 27 years.
As well as In-House programmes we run virtual and blended public courses.
