Software Validation

Laws, Regulations and Guidelines for Software Validation
The course will examine the regulations surrounding the current requirements for the validation of software and computer systems used in Manufacturing, QA, Regulatory and the Control of Processes, both prospectively and retrospectively. Both FDA and EU regulatory guidelines will be discussed with regard to the Medical Device and Pharmaceutical industries. The use of the current GAMP guidelines as a method of compliance with the regulations will be discussed.

The Software Validation Life Cycle
The life cycle from design, through construction, installation and live start-up for a typical software project will be described with details on the contents of key documents / activities such as URS, FDS, VMP, IQ, OQ and PQ.

Electronic Signatures and Records
This section of the course introduces the regulations governing the use of Electronic Records and Electronic Signatures in a regulated environment. Details of the requirements of 21 CFR 11 will be examined and the current expectations of the FDA with regard to implementation will be discussed.

Risk Assessment
This section will look at the objectives for risk assessment, and will discuss the various guidelines and techniques involved. The programme will cover the implementation of risk assessment to ensure critical risks are identified and the correct level of validation is carried out.

Personnel in the Pharmaceutical/Medical Device/Healthcare sectors who need to gain a solid foundation in the principles of Computer Systems Validation in a regulated environment.

Participants achieve the following learning outcomes from the programme;

• Apply the principles of Software Validation and Computer Systems Validation.
• Implement the Validation Life Cycle approach to software and computer systems
• Apply Quality Risk Management techniques.
• Generate key validation documents such as URS, FDS, VMP, IQ, OQ and PQ.
• Apply the requirements of 21 CFR part 11 in relation to Electronic Signatures & Records.

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  Carmel McCrea Kelly

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

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  John Lafferty

  John Lafferty, B. Tech. in Manufacturing Technology, Six Sigma ...

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