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Business Excellence Skillnet

We are pleased to be able to offer a limited number of free places for jobseekers on our network programmes

Please click on the following link to check if you meet Jobseekers eligibility criteria;

CLICK HERE TO BOOK NOW

DATES: 10th June 2013

TIMES: 9.30 am – 5.00 pm

LOCATION: Training Point Raheen Industrial Estate Raheen Limerick

COST: €175.00 per member €210.00 non member

 

 Programme Overview

 

This Good Laboratory Practice training course is a 1 Day public programme, designed to provide participants with the principles of good laboratory practice for personnel of laboratories who wish to produce test results that are fit for the purpose and which would stand up to the scrutiny of Good Laboratory Practice Compliance Inspectors/FDA Inspectors.

Training Content

 

The drug development process and the non-regulated vs. regulated areas

A History of GLP and its application

The origins of GLP

What is GLP?

 

Good Laboratory Practice

Background

The FDA’s & OECD’s GLPs

The effects of two Regulatory regimes

 

THE FUNDAMENTAL POINTS OF GLP

Resources

Organisation and personel

Facilities and Equipment

Rules

Protocols

Written procedures

 The study director

Characterization

Documentation

 

 

Raw Data

Study Report

Archives

Quality assurance

 

RESOURCES

Facilities: buildings and equipment

Buildings: General Principles

Pharmacy and dose mixing areas

Animal Facility

Equipment

Documentation

Good Science

Good Organisation

CHARACTERIZATION

The test item

Test item control before formulation

Preparation of the dose formulation

 Test system

Introduction

Facilities

Choice of the test system

Suppliers, ordering, transport and arrival

Acclimatization

Animal identification

Assignment to groups

Husbandry

Control and monitoring of environmental variables

 

DOCUMENTATION – RAW DATA AND DATA COLLECTION

Carrying out procedures and recording observations

Records and recording

 

QUALITY ASSURANCE UNIT

Protocol (or study plan) review

SOP review

Planning (Master schedule, inspection plan)

Audits and inspections

Study based inspections/ audits

Process –based inspections

Final report / raw data audit

Quality assurance statement

QAU inspections of suppliers and contractors

The distribution and archiving of QAU files and reports

 

OECD & FDA GLPs: Key Differences

Terminology

Comparing FDA and OECD GLPs

Laboratory certification

Authority inspections

Archiving requirements

 

STEPWISE IMPLEMENTATION OF GLP

Introduction

Implementation as a project

Initiating the GLP Project

Implementation of GLP requirements

 

 

Audience

 

This Good Laboratory Practice training programme may be of interest to laboratory managers, supervisors, technicians and analysts who wish to increase their understanding of good laboratory practice.

 

Training Company Name

Training Point  Raheen Limerick

 

Dr. John Fitzgerald

Dr. John Fitzgerald is a corporate consultant providing consultancy and training in Management Skills & Personal Development and specialising in areas such as, Professional Minute Taking, Presentation Skills, Negotiation skills deal with conflict management & resolution training.  John has delivered training for Procad Training for a number of years now and is a highly qualified and experienced Management Skills Trainer and always consistently delivering top quality courses for Procad Training over these years.

John creates an atmosphere of openness and trust in which people feel free to share.  John sets high performance standards for himself and excels in obtaining results.  His commitment, excellent organisational and professional manner is a credit to him.

 

 

The Business Excellence Skillnet is funded by member companies and the Training Networks Programme, an initiative of Skillnets Ltd. funded from the National Training Fund through the Department of Education and Skills.

 

For more information on Skillnets Ltd, please visit www.skillnets.ie

We are pleased to be able to offer a limited number of free places for jobseekers on our network programmes subject to funding being available. Please click on the following link to check if you meet Jobseekers eligibility criteria

Skillnets funded from the National Training Fund through the Department of Education and Skills

 


 

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