Basic Principles of GMP Introduction to the Training

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

Introduction Objectives of this Introductory Session l To outline the programme l To introduce your trainers l l Module 1 To introduce you to one another and to understand your objectives and background To understand the way these modules work Slide 2 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 Module 1 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 Module 1 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 Module 1 Slide 5 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 Module 1 Slide 6 of 16 WHO - EDM

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

Introduction Who am I? l Name l Experience l Objectives l Not a lot of people know………. . Module 1 Slide 8 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 Module 1 Slide 9 of 16 WHO - EDM

Introduction Our Way of Working l A presentation on the subject of the module - usually no more than 60 minutes äfollows the WHO text as the basis of the module äwill 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 Module 1 Slide 10 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 Module 1 Slide 11 of 16 WHO - EDM

Introduction Working in Groups Please accept shared responsibility in each group for: l Dialogue l Participation l Shared ideas l Enabling others to participate l Shared understanding l Active listening l Shared meaning l Agreeing to disagree l Clarifying Module 1 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. … 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” 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: l a Regional level l National level l Organisational level l Personal level. Module 1 Slide 14 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: Specific Measurable Action-oriented Realistic Time-related Module 1 Slide 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 Objectives should be developed in the SMART format: Specific, Measurable, Action-oriented, Realistic, Time-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 Module 1 Slide 16 of 16 WHO - EDM