Basic Principles of GMP

Introduction

to the Training Course

Module 1

Slide 1 of 16

WHO - EDM

Introduction
Objectives of this Introductory Session

To outline the programme To introduce your trainers

To introduce you to one another and to understand your objectives and background
To understand the way these modules work

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Slide 2 of 16

WHO - EDM

Introduction
Programme Overview I

Basic Principles of GMP

1. 2. 3. 4. 5. Introduction to the training programme Quality Management Sanitation and hygiene Validation Complaints and recalls

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Slide 3 of 16

WHO - EDM

Introduction
Programme Overview II

Basic Principles of GMP

6. Contract production and analysis 7. Self Inspection 8. Personnel 9. Premises 10. Equipment

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Slide 4 of 16

WHO - EDM

Introduction
Programme Overview III

Basic Principles of GMP

11. Materials 12. Documentation 13. Sterile production 14. Active pharmaceutical ingredients

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Slide 5 of 16

WHO - EDM

Introduction
Programme Overview IV

GMP Inspection Process

15. 16. 17. 18. 19. 20.
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Introduction The role of the inspector Preparation for the inspection Types of GMP inspection The inspection Trainers notes
Slide 6 of 16
WHO - EDM

Introduction
Your Team
Who are we?

Trainers
(Name) (Qualifications) (Experience) (Name) (Qualifications) (Experience)

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Slide 7 of 16

WHO - EDM

Introduction
Who am I?

Name Experience

Objectives
Not a lot of people know..

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Slide 8 of 16

WHO - EDM

Introduction
Objectives of the training course

To introduce general elements on quality management

To train you in the WHO GMP texts for pharmaceutical products To bring in your own experience To develop your own action plan

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Slide 9 of 16

WHO - EDM

Introduction
Our Way of Working

A presentation on the subject of the module - usually no more than 60 minutes

follows the WHO text as the basis of the module will have the WHO reference at the bottom of the slide

A 30-60 minutes group session discussing issues or a problem that will be set for you
Group feedback in plenary session

Multiple choice quiz

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Slide 10 of 16

WHO - EDM

Introduction
How the Group Session and Feedback works

Move to your area and select a group chairperson, a timekeeper, a recorder and reporter to present the groups views to the combined meeting
Identify the issues to be discussed.

Discussion:
fundamental to the learning process need enthusiastic participation needs a brainstorming approach

Module 1

Document the groups views on 1 flip-chart page Maximum of 10 minutes for each groups presentation
Slide 11 of 16
WHO - EDM

Introduction
Working in Groups
Please accept shared responsibility in each group for:

Dialogue Shared ideas

Participation Enabling others to participate Active listening Agreeing to disagree

Shared understanding
Shared meaning Clarifying

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Slide 12 of 16

WHO - EDM

Introduction
Working in Groups
When someone says something which does not agree with your views, . or seems wrong to you.

Do not immediately say

Thats wrong or How stupid

Pause; Reflect What do they really mean? Say instead An interesting idea or thats a different way of looking at it

Module 1

Slide 13 of 16

WHO - EDM

Introduction
Group Session
Discuss the GMP issues you each face in your own countries Identify key objectives to be achieved in attending this programme at:

a Regional level National level Organisational level Personal level.

Module 1

Slide 14 of 16

WHO - EDM

Introduction
Group Session

Identify key objectives to be achieved in attending this programme, at a Regional level, at a National level, at an Organisation level and at a personal level. Set objectives using the SMART formula: Specific Measurable Action-oriented Realistic Time-related

Module 1

Slide 15 of 16

WHO - EDM

Introduction
Group Session

Identify key objectives to be achieved in attending this programme, at a Regional level, at a National level, at an Organisation level and at a Personal level. Objectives should be developed in the SMART format: Specific, Measurable, Action-oriented, Realistic, Time-related Identify 3 success criteria by which the objective will be measured. Please observe the times allowed: 1 hour maximum discussion 5 - 10 minutes maximum feedback for each group
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WHO - EDM

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