Laboratory Systems Validation

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Validation of equipment and methods is a vital element in assuring the integrity of results from laboratories in the pharmaceutical, healthcare and medical device industries. This course covers the life cycle for laboratory equipment validation, from... Read More

Validation of equipment and methods is a vital element in assuring the integrity of results from laboratories in the pharmaceutical, healthcare and medical device industries. This course covers the life cycle for laboratory equipment validation, from requirements specification to installation, operation and performance testing. It addresses the requirements for the control of electronic records and signatures within a laboratory environment. The course is aimed at fulfilling the requirements of the latest industry requirements such as; ICH, USP, 21 CFR Part 11 and GAMP.

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What's covered?

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  • Guidelines for Laboratory System Validation focusing on the current regulations from the FDA and EU authorities in the area of GLP.
  • Laboratory Equipment Validation - The life cycle for laboratory equipment validation from specification to installation validation and start up for a typical lab equipment project.
  • Contents of key documents / activities such as URS, FDS, VMP, IQ, OQ and PQ as applied to the laboratory environment.
  • Laboratory Method Validation- the ICH methodology for analytical procedures. Methods requiring verification and validation of these methods using a standard approach.
  • Laboratory Software Validation Considerations – control of computerised systems within the laboratory environment. Security, Back-up, Disaster planning, and the implications of 21 CFR part 11.

Who should attend?

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  • Laboratory Managers, Supervisors and Technicians who wish to increase their understanding of Laboratory Systems and Software Validation
  • Development Chemists / Microbiologists

What will I learn?

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Participants achieve the following learning outcomes from the programme;

  • Demonstrate a working knowledge of the fundamentals and principles of validation and how they are applied in a laboratory.
  • Generate key validation documents such as URS, FDS, VMP, IQ, OQ and PQ.
  • Apply the fundamentals of analytical test method validation to laboratory methods.
  • Apply the requirements of 21CFR Part 11 in the laboratory environment

Who are the tutors?

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Duration
1 training day
Course Times
9.00am - 5.00pm
Price
€450

(includes course documentation, lunch and refreshments)

Delivery Mode
This programme is available In-House and on certain Public dates

What They SayWhat They Say

Excellent presentation and feel I learned a lot of new information on validation. The tutor is very knowledgeable in the area

– Claire Canavan, Medical Scientist, Mater Private Hospital

Laboratory Systems Validation

Duration: 1 dayPublic Price: €450
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