Laboratory Systems Software Validation in a Regulated

Document Sample
Laboratory Systems Software Validation in a Regulated Powered By Docstoc
					             Laboratory Systems & 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 specification to installation, operational 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.

COURSE OBJECTIVES

On completing this course participants will 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 validations 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- ICH text on methodology for analytical procedures.
       Methods to be verified 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 MANUAL

This course comes with a very comprehensive manual, which proves to be an excellent source of
reference after the course.


COURSE PRESENTER - JOHN LAFFERTY

John Lafferty:
John Lafferty graduated from University College Galway in 1986 with a degree in Manufacturing
Technology. John spent 17 years working in the Medical Devices and Pharmaceutical Packaging
manufacturing sectors in Quality, Manufacturing Engineering and Process Engineering. He spent 6
years as a Senior Manager in a multinational Medical Devices plant where he managed the Quality,
Environmental Management and Health & Safety Systems.
A Six Sigma Green Belt with many years experience in Validation, Risk Management, Problem
Solving and Process Improvement, John runs a Quality Management consultancy business,
Northridge Management Services in Letterkenny.

John holds a Certificate in Training and Continuing Education from NUI Maynooth and is currently
undertaking a Six Sigma Black Belt qualification.

TRAINING METHODOLOGY
This classroom-based course is highly interactive. All courses use accelerated learning where
possible. Courses use PowerPoint slides and other multimedia where appropriate.
Practical examples are given throughout all courses.

IN-HOUSE COURSES

All SQT courses are available on an in-house basis. On in-house courses, the tutor will work with
the customer in advance to clearly define course objectives to meet the specific delegate and
company requirements. Where appropriate and facilitated by the company, the course exercises can
be carried out using the company’s own case studies, procedures, forms, metrics etc.

Course Dates &           Course Times        Public Course Cost € 395
Venues                   9.00am - 5.00pm     (includes course documentation, lunch and refreshments)
See attached Calendar

                                              Rev 06