TRAINEE - World Health Organization

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ABOUT THIS TRAINING MANUAL This manual is a support document for the WHO good laboratory practice (GLP) training programme. The training is designed to provide information about the Organisation for Economic Cooperation and Development (OECD) GLP Principles which are recognized as the international standard for GLP. The training is spread over a three-day period. In general the first 1 1⁄2 days will be spent on presentations relating to GLP Principles. The next 1 1⁄2 days will be devoted to workshops and discussion groups. The training programme first explains GLP requirements and then examines in more detail, through intensive workshop activities, the problems relating to writing study plans (protocols) and standard operating procedures (SOPs). Thanks should be expressed to the following people who contributed to the completion of this manual: David Long, Nick Kail, David Ford, Nadya Gawadi and Phil Withers. Without the help of these people the manual could not have been compiled. The manual is divided into two main parts. The first part (Chapters 1-6) deals with the GLP requirements through presentations based on the five fundamental points (Resources, Rules, Characterisation, Documentation and Quality Assurance). These are first explained very briefly in Chapter 1, where you will also find an introduction to the subject of GLP and a few remarks on the history of GLP including why it was necessary to implement this regulation. Each of the first 6 chapters has the same format: a text to explain the subject, followed by a copy of each of the slides used during the presentation. Participants can thus follow the presentation on the screen at the same time as in the manual (where they can make notes if they wish). The explanatory notes can then be used at some convenient time after the course has finished to read up about the subject. The second part of the manual (Chapters 7-9) contains limited information on the workshops relating to protocols and to SOPs. The instructors have all the workshop material and this will only be distributed when necessary, on days 2 and 3 of the course. The first two workshops are designed to encourage participants to think about the salient points when writing protocols (Chapter 7) and SOPs (Chapter 8). The participants will be able to use the information acquired during the more formal first day of presentations to help them during their workshops. 1
2 <strong>TRAINEE</strong>S About this Training Manual • GLP Training Manual In both workshops there are, of course, many ways of dealing with the problems presented, so that each workshop group may well have a different approach. This is perfectly normal. It is both interesting and instructive to have divers opinions on how to respond positively to the GLP requirements. One of the reasons for doing workshops on these topics is to stimulate discussion between participants, because it is through debate that a real understanding of the issues develops. The third workshop (Chapter 9) is really a private exercise. You are provided with a multiple-choice questionnaire and with the answers. Answer the questionnaire at your leisure and check whether you have the correct answers. If you get the right answer, all well and good. If your answer is inaccurate, you should re-read the chapter in the manual that deals with the problem and also refer to the OECD GLP Principles or the consensus documents until you find the answer you are looking for.
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TRAINEE - World Health Organization

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