Laboratory Software Validation

Our fully interactive Laboratory Software Validation 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, providing attendees with a well-thought-out approach and real-world implementation methodologies to help achieve compliance and assure consistency of performance of computerised systems. This course covers the validation of standalone software such as LIMS systems, statistical packages and databases as well software contained in laboratory equipment ranging in complexity from centrifuges to integrated HLPC systems. The course also covers the latest FDA Requirements and Guidance on Electronic Records and Signatures (21 CFR Part 11) and Quality Risk Management as applied to Software Validation and Computer Systems Validation. 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 brochure, see end of brochure.

Delivery Mode

  • Public
    Programmes

    Dates
    06 - 07 Nov 2024
  • Virtual
    Training
    Programmes

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  • Customised
    In-Company
    Programmes

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SnapshotSnapshot

Course Code
L009

What's covered?

Day 1

  • The Need for Software Validation in the Laboratory
  • European and FDA Regulations and Guidance on Laboratory Software Validation
  • The latest FDA Guidance on Software Validation New
  • Group Discussion the latest FDA Guidance on Software Validation New
  • The GAMP Approach to Software Validation
  • The V Model ApproachV Model Approach interactive exercise
  • Software Validation Planning - designing Master Validation Plans
  • 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

Day 2

  • Case Study writing an equipment IQ Protocol
  • Software Testing and Software Test Environments
  • Software Testing Interactive Exercise
  • Case Study writing an equipment OQ Protocol
  • 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

Who should participate?

  • Laboratory Managers, Supervisors and Technicians who wish to increase their understanding of Laboratory Systems and Software Validation
  • Laboratory Staff who will be involved in the validation of laboratory systems, equipment and software.
  • IT personnel who will be involved in laboratory software valid

What will I learn?

Upon completion of this course, participants will be able to;

  • Identify the regulatory requirements for Laboratory Software Validation
  • Categorise software in accordance with GAMP guidelines
  • Apply the V Model to Laboratory 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
  • Leverage vendor documentation to minimise validation effort
  • Report on Software testing results
  • Assist in ensuring that the validated state is maintained

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. In-house courses can be customised to meet your organisation’s specific requirements. Where appropriate, course exercises can be carried out using procedures, data etc from your organisation.

Course Manual
Delegates will receive a very comprehensive course manual.

Acronyms used in this document.

CFR Code of Federal Regulation (US Federal Law)
EU European Union
FDA Food and Drugs Administration
FDS Functional Design Specification
GAMP Good Automated Manufacturing Practice (Industry Guidance)
GLP Good Laboratory Practice
GMP Good Manufacturing Practice
IQ Installation Qualification
LIMS Laboratory Information Management Systems
OQ Operational Qualification
PQ Performance Qualification
URS User Requirements Specification
MVP Master Validation Plan

John Lafferty

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  • 06 - 07 Nov 2024

John Lafferty

Duration: 2 days
Virtual Training: €695
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  • 06 - 07 Nov 2024
    Delivery: Virtual Training Location: Virtual Book Date

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