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Process Validation for Medical Laboratories by fhy50518

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									            Process Validation for Medical Laboratories
                                      One Day Training Course

BACKGROUND
European Union Directives 2005/62/EC & 2006/86/EC require that all procedures, premises &
equipment that have an influence on the quality & safety of blood components, tissue & cells shall
be validated prior to introduction & be revalidated at regular intervals. Storage & distribution
processes should be validated to ensure blood & or tissue component quality.
Process validation is a term used to indicate that a process has been subject to such scrutiny that the
results of the process can be practically guaranteed. It is vitally important if the predetermined
requirements of the process can only be assured by destructive testing. A comprehensive, well
thought-out approach to validation is a key element in assisting any laboratory meet regulatory
inspection requirements.

COURSE OBJECTIVES
The objectives of this course are to;
   • Gain an understanding of the regulatory requirements for process validation
   • Appreciate the benefits of conducting validation studies.
   • Understand the key elements of process validation
   • Review European & FDA Guidance publications on process validation
   • Understand what is needed to prepare a validation master plan, validation protocols &
       reports
   • Overview equipment validation requirements
   • Appreciate the main requirements for maintaining a state of validation

WHO SHOULD ATTEND
This course is intended for:
   • Personnel in the Medical Laboratory responsible for validation & involved in accreditation
       validation activities.

COURSE PROGRAMME

   •   Introduction
   •   Business Benefits of Process Validation
   •   Validation Regulatory Requirements & Guidelines
   •   Validation Master Plan
   •   Equipment Qualification
   •   Cleaning Validation
   •   Preparing a Process Validation Protocol
   •   Preparing a Process Validation Report
   •   Maintaining a state of validation
   •   Review of in-house laboratory templates
COURSE MANUAL
This course comes with a very comprehensive manual, which proves to be an excellent source of
reference after the course.

IN-HOUSE COURSES
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 PRESENTER Mary Rose O' Mahony
BACKGROUND
Mary Rose O' Mahony has 19 years experience in the Healthcare industry
  • 10 years at Management & Senior Management level in the Pharmaceutical & Medical
     Device Industry working in Quality, Technical Services, Validation & Production
  • 9 years as a training consultant in implementing quality systems
  • Extensive experience working in FDA, IMB & ISO regulated companies
  • Established and managed plant-wide validation programmes
  • Managed new product introductions
  • Graduated with a B.Sc. and Ph.D. in Industrial Microbiology from University College
     Dublin.
TRAINING METHODOLOGY
This classroom based course is highly interactive and uses practical exercises and simulated
case studies to reinforce understanding and learning.

THIS COURSE IS AVAILABLE EXCLUSIVELY               Course Times
ON AN IN-HOUSE BASIS.                              9.00am - 5.00pm

                                               Rev 1

								
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