Software Validation Training Course - Computer Systems Validation FDA European requirements

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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.

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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

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.

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

Carmel McCrea Kelly

Carmel McCrea Kelly, BSc in Quality Management & Technology...

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John Lafferty

John Lafferty is a Quality professional with over 25 years expe...

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Snapshot

Course Code

LS035

Duration

3 training days

Public Price

Virtual Training: €995

(includes course documentation).

Delivery Mode

This programme is delivered by Classroom, Virtual Training, or In-Company training

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