Waarom dit thema?
GLP is a quality system including organisational and technical aspects with regard to the implementation of non-clinical health and environmental safety studies.
The understanding and implementation of the GLP Principles is fundamental for the application of non-clinical health and environmental safety studies. The application of GLP Principles is mandatory for non-clinical safety testing of test items in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as food additives, feed additives, and industrial chemicals and other products as required by national regulation or legislation.
Waarom deze opleiding?
A lot of actors (sponsors, management, study directors, study personnel, quality assurance staff, IT personnel and archivists) are involved in the development, implementation and follow-up of a GOOD LABORATORY PRACTICE (GLP) quality system. Therefore, correct understanding and interpretation of the content of the principles of GLP and related documents are crucial before reliable data are produced with the purpose to register or license the test items of different origin.
The programme of this GLP training course will be focused to
- Introduction to GLP, legal aspects, documentation, mutual acceptance of data, processes
- Responsibilities sponsor, management, study director, principal investigator, study personnel, IT personnel and archivist
- Management of facilities, apparatus, test items and test systems.
- Setup of standard operating procedures
- Performance, reporting and archiving of GLP studies
- Quality Assurance Program
The organization of this GLP Training Course exists of presentations, questions and answers and individual exercises.
The GLP workshop is an advanced GLP training course where it is recommended that participants have a basic knowledge and experience of the OECD GLP Principles or other quality system.
Meer info nodig?
Inhoud
Day 1
8:30 Welcome and coffee
9:00 Introduction
9:15 Individual exercise 1: test of basic GLP knowledge
9:40 General aspects of GLP
10:40 Questions and answers
10:55 Coffee Break
11:10 Organisation and personnel
12:15 Questions and answers
12:30 Lunch
13:45 Facilities
14:15 Apparatus and related materials
14:45 Test items
15:15 Coffee break
15:30 Test systems
16:00 Standard Operating Procedures
16:30 Archives
17:00 Questions and answers
17:15 Individual exercise 2: organisational aspects
17:30 End
Day 2
9:00 Discussion and evaluation of exercises
9:30 Performance of GLP studies
10:30 Questions and answers
10:45 Coffee break
11:00 Reporting of GLP studies
11:45 Archiving of GLP studies
12:15 Questions and answers
12.30 Lunch
13.45 Quality Assurance Program
14:45 Questions and answers
15.00 Coffee break
15.15 Group exercise: performance and reporting of a GLP study
16:15 open discussion and interaction between the groups
17:15 Conclusions
17u30 End
Waar & wanneer
Prijs
Ledenprijs
Nog geen lid? Lid worden kan al vanaf € 205 per jaar
Deze opleiding goedkoper volgen?
- Bekijk op welke subsidies (o.a. KMO-portefeuille) je recht hebt
- Korting mogelijk bij meerdere deelnemers van hetzelfde bedrijf
Docenten
- jarenlang lid van de OECD en EU GLP stuurgroep
- uitgebreide ervaring in het geven van GLP opleidingen wereldwijd
Op maat
Liever een oplossing op maat?
- Win het advies in van een ervaren vakspecialist, en doe beroep op een consultant.
- Meerdere collega's die deze opleiding willen volgen? Al vanaf 4 deelnemers is in-company voordeliger.
- Aangepast op basis van de noden van jouw organisatie.