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Basic Principles of GMP. Introduction to the Training Course. 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

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slide1

Basic Principles of GMP

Introduction

to the Training Course

introduction
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
introduction1
Introduction

Programme Overview – I

Basic Principles of GMP

1. Introduction to the training programme

2. Quality Management

3. Sanitation and hygiene

4. Validation

5. Complaints and recalls

introduction2
Introduction

Programme Overview – II

Basic Principles of GMP

6. Contract production and analysis

7. Self Inspection

8. Personnel

9. Premises

10. Equipment

introduction3
Introduction

Programme Overview – III

Basic Principles of GMP

11. Materials

12. Documentation

13. Sterile production

14. Active pharmaceutical ingredients

introduction4
Introduction

Programme Overview – IV

GMP Inspection Process

15. Introduction

16. The role of the inspector

17. Preparation for the inspection

18. Types of GMP inspection

19. The inspection

20. Trainers’ notes

introduction5
Introduction

Your Team

Who are we?

  • Trainers
    • (Name)
    • (Qualifications)
    • (Experience)
    • (Name)
    • (Qualifications)
    • (Experience)
introduction6
Introduction

Who am I?

  • Name
  • Experience
  • Objectives
  • Not a lot of people know………..
introduction7
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
introduction8
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
introduction9
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 group’s views to the combined meeting
  • Identify the issues to be discussed.
  • Discussion:
    • fundamental to the learning process
    • need enthusiastic participation
    • needs a “brainstorming approach”
  • Document the group’s views on 1 flip-chart page
  • Maximum of 10 minutes for each group’s presentation
introduction10
Introduction

Working in Groups

Please accept shared responsibility in each group for:

  • Dialogue
  • Shared ideas
  • Shared understanding
  • Shared meaning
  • Clarifying
  • Participation
  • Enabling others to participate
  • Active listening
  • Agreeing to disagree
introduction11
Introduction

Working in Groups

When someone says something which does not agree with your views, ….

or seems wrong to you.…

  • Do not immediately say

“That’s wrong” or “How stupid”

  • Pause; Reflect
  • “What do they really mean?”
  • Say instead

“An interesting idea” or

“that’s a different way of looking at it”

introduction12
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.
introduction13
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:

SpecificMeasurableAction-orientedRealistic Time-related

introduction14
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