Software Validation

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. For abbreviations used in this document, see end of document.

Delivery Mode

  • Public
    Programmes

    Dates
    23 - 25 Apr 2024(Full)
    24 - 26 Sep 2024
    03 - 05 Dec 2024
  • Virtual
    Training
    Programmes

    Contact Us
  • Customised
    In-Company
    Programmes

    Contact Us

SnapshotSnapshot

Course Code
LS035

What's covered?

DAY 1

  • 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

DAY 2 

  • 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

DAY 3 

  • 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

Who should participate?

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.

What will I 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.

 

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

Who are the tutors?

John Lafferty

John Lafferty is a Quality professional with over 25 years experience in the medical device and pharmaceutical industry. John joined SQT as a tutor in 2007. Prior to that, John spent many years working in the Medical Devices/ Pharmaceutical sectors – the final six years of which were as a Senior Manager of a multinational Medical Devices plant where he managed the Quality and Regulatory Systems. John completed his Lean Six Sigma Black Belt training through SQT in 2009 and derives great benefit from applying the techniques that he learned to Risk Management and Validation in a Life Sciences setting. “It is great to be able to bring this knowledge, and the experience gained from ongoing involvement with Life Sciences companies, into the classroom,” he says.

John passionately believes that the key to success in Life Sciences Manufacturing is the relentless application of Risk Management, Variation Reduction and Good Validation Practices. As the SQT tutor for Technical Writing Skills, John believes that good written communication skills are vital for any Life Sciences professional.

John holds the following qualifications: a Bachelor of Technology in Manufacturing Technology, a Six Sigma Black Belt, a Certificate in Training & Continuing Education and a Certificate in Quality Management. John is a member of the following committees relating to Risk Management of Medical Devices; ISO TC 210 – Medical Devices Technical Committee and CEN/ISO JWG1 – Joint Working Group on Risk Management.

One of John’s greatest achievements, in recent years, has been the development of the MDSAP and MDSAP Internal Auditor courses in response to demand from SQT’s loyal client base.


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.

John Lafferty

Duration: 3 days **
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  • 23 - 25 Apr 2024
    Sorry, this date is full – please contact SQT to add your name to a waitlist.
  • 24 - 26 Sep 2024
    Location: Virtual Book Date
  • 03 - 05 Dec 2024
    Location: Virtual Book Date

John Lafferty

Duration: 3 days
Virtual Training: €995
Hide
  • 23 - 25 Apr 2024
    Sorry, this date is full – please contact SQT to add your name to a waitlist.
  • 24 - 26 Sep 2024
    Delivery: Virtual Training
    Location: Virtual
    Book Date
  • 03 - 05 Dec 2024
    Delivery: Virtual Training
    Location: Virtual
    Book Date

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