Laboratory System & Software Validation in a Regulated Environment

 Laboratory System & Software Validation in a Regulated Environment

One Day Training Course

Background

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.

Learning Outcomes

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

• 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 Should Attend

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

Course Programme

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.

Course Tutor

John Lafferty

Testimonials

Click Here

Course Dates & Venues

Click Here

Course Times

9.00am - 5.00pm

Public Course Cost

€395 (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.