1. Module 1Slide 1 of 16 WHO - EDM Introduction to the Training Course Basic Principles of GMP

2. Module 1Slide 2 of 16 WHO - EDM Introduction Objectives of this Introductory Session l To outline the programme l To introduce your trainers l To introduce you to one another and to understand your objectives and background l To understand the way these modules work

3. Module 1Slide 3 of 16 WHO - EDM 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

4. Module 1Slide 4 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

5. Module 1Slide 5 of 16 WHO - EDM Introduction Programme Overview – III Basic Principles of GMP 11. Materials 12. Documentation 13. Sterile production 14. Active pharmaceutical ingredients

6. Module 1Slide 6 of 16 WHO - EDM 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

7. Module 1Slide 7 of 16 WHO - EDM Introduction Your Team Who are we? l Trainers ä (Name) ä (Qualifications) ä (Experience) ä (Name) ä (Qualifications) ä (Experience)

8. Module 1Slide 8 of 16 WHO - EDM Introduction Who am I? l Name l Experience l Objectives l Not a lot of people know………..

9. Module 1Slide 9 of 16 WHO - EDM Introduction Objectives of the training course l To introduce general elements on quality management l To train you in the WHO GMP texts for pharmaceutical products l To bring in your own experience l To develop your own action plan

10. Module 1Slide 10 of 16 WHO - EDM Introduction Our Way of Working l A presentation on the subject of the module - usually no more than 60 minutes ä follows the WHO text as the basis of the module ä will have the WHO reference at the bottom of the slide l A 30-60 minutes group session discussing issues or a problem that will be set for you l Group feedback in plenary session l Multiple choice quiz

11. Module 1Slide 11 of 16 WHO - EDM Introduction How the Group Session and Feedback works l 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 l Identify the issues to be discussed. l Discussion: ä fundamental to the learning process ä need enthusiastic participation ä needs a “brainstorming approach” l Document the group’s views on 1 flip-chart page l Maximum of 10 minutes for each group’s presentation

12. Module 1Slide 12 of 16 WHO - EDM Introduction Working in Groups Please accept shared responsibility in each group for: l Dialogue l Shared ideas l Shared understanding l Shared meaning l Clarifying l Participation l Enabling others to participate l Active listening l Agreeing to disagree

13. Module 1Slide 13 of 16 WHO - EDM Introduction Working in Groups When someone says something which does not agree with your views, …. or seems wrong to you.… l Do not immediately say “ That’s wrong” or “How stupid” l Pause; Reflect l “What do they really mean?” l Say instead “An interesting idea” or “that’s a different way of looking at it”

14. Module 1Slide 14 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: l a Regional level l National level l Organisational level l Personal level.

15. Module 1Slide 15 of 16 WHO - EDM Introduction Group Session l 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. l Set objectives using the SMART formula : S pecific M easurable A ction-oriented R ealistic T ime-related

16. Module 1Slide 16 of 16 WHO - EDM Introduction Group Session l 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: S pecific, M easurable, A ction-oriented, R ealistic, T ime-related l Identify 3 success criteria by which the objective will be measured. l Please observe the times allowed : ä 1 hour maximum discussion ä 5 - 10 minutes maximum feedback for each group