SQT Training Software Validation Course

By Gemma Creagh - Last update

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Are you working in the Pharmaceutical/Medical Device/Healthcare sector and would like to gain a solid foundation in the principles of Computer Systems Validation? Then SQT training has just the course for you, kicking off later this month. The main objectives of this programme are to give attendees a grounding in the principles of Software Validation, Computer Systems Validation and the latest requirements for Electronic Records and Electronic Signatures.

About this Software Validation Course

The course provides an overview of the FDA and European requirements with practical exercises covering the implementation of those requirements. The course covers the application of these requirements to the validation of both computer hardware and software systems used in Manufacturing, QA, Regulatory and the Control of Processes. 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.

What’s covered?

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.

To find out more about the details of the course, click here, although the next scheduled course will take place 21st – 22nd May 2019.


Gemma Creagh

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