Computer Systems Validation and Electronic Records & Signatures

Computer System Validation & Electronic Records and Signatures

Two Day Training Course

Background

The main objectives of this course are to give attendees a grounding in the principles of Computer Systems Validation and the latest requirements for Electronic Records and Electronic Signatures. 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 Computer Systems Validation.

Learning Outcomes

On successful completion of this training course, delegates should be able to:

• Apply the principles of Computer Systems Validation
• Implement the Validation Life Cycle approach to 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

Who Should Attend

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.

Course Programme

Laws, Regulations and Guidelines for Computer Systems Validation
The course will examine the regulations surrounding the current requirements for the validation of software and control systems, 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 Computer 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.

Course Tutor

John Lafferty

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Course Times

9.00am - 5.00pm

Public Course Cost

€790 (includes course documentation, lunch and refreshments)

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.