This document outlines an introductory training session on Good Manufacturing Practices (GMP). It introduces the trainers and objectives of the course. The training will cover 15 modules related to GMP based on WHO guidelines. Trainees will work in groups to discuss GMP issues in their countries and set objectives for attending the training at regional, national, organizational and personal levels using the SMART framework. The group work will be followed by feedback sessions.
Line clearance is a procedure to ensure equipment and work areas are free from materials from previous processes and ready for the next process. It involves clearing equipment of previous materials, cleaning, and checking. The purpose is to prevent mix-ups, contamination, and cross-contamination between products and batches. Proper line clearance, cleaning, separation of lines, and changeover approval are important cGMP requirements.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
The document outlines good manufacturing practices (GMP) that must be followed to produce safe products. It discusses personnel hygiene practices, facility requirements, storage practices, process equipment guidelines, cleaning and sanitation procedures, pest control measures, and documentation standards that are necessary to ensure product quality and safety.
This document appears to be an inspection report form used by inspectors from the World Health Organization (WHO) to inspect pharmaceutical manufacturing firms and ensure compliance with Good Manufacturing Practices (GMP). The form includes sections to record details of the firm, personnel, facilities, equipment, materials, documentation, production processes, and compliance with GMP standards. Inspectors would use this form to systematically evaluate all aspects of the facility and operations during an inspection.
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
The Product Quality Review (PQR) is a regular review of all licensed medicinal products conducted to verify consistency of manufacturing processes and the appropriateness of specifications. The objectives of the PQR include determining the need for process, specification or validation changes; verifying compliance; identifying trends; and determining corrective actions. The EU requires annual PQRs that review areas like starting materials, process and product testing results, failed batches, deviations, changes made, and stability monitoring results. The PQR is intended to enhance quality and identify improvements.
The document discusses Good Manufacturing Practices (GMP) and contamination prevention. It covers types of contamination, sources, and how to prevent them through practices like personal hygiene, sanitation, cleaning, and equipment maintenance. GMP regulations require facilities, equipment, personnel training, and documentation to help assure product quality and safety.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
Line clearance is a procedure to ensure equipment and work areas are free from materials from previous processes and ready for the next process. It involves clearing equipment of previous materials, cleaning, and checking. The purpose is to prevent mix-ups, contamination, and cross-contamination between products and batches. Proper line clearance, cleaning, separation of lines, and changeover approval are important cGMP requirements.
Process Validation is Key important factor for the Pharmaceutical Industry to maintain Consistent Quality in product which claimed by the manufacturer.
The document outlines good manufacturing practices (GMP) that must be followed to produce safe products. It discusses personnel hygiene practices, facility requirements, storage practices, process equipment guidelines, cleaning and sanitation procedures, pest control measures, and documentation standards that are necessary to ensure product quality and safety.
This document appears to be an inspection report form used by inspectors from the World Health Organization (WHO) to inspect pharmaceutical manufacturing firms and ensure compliance with Good Manufacturing Practices (GMP). The form includes sections to record details of the firm, personnel, facilities, equipment, materials, documentation, production processes, and compliance with GMP standards. Inspectors would use this form to systematically evaluate all aspects of the facility and operations during an inspection.
The document discusses batch production record (BPR) review and release. It defines key terms like deviations, critical process parameters, critical quality attributes. It outlines regulatory requirements from ICH Q7, CFR 211, and consequences of non-compliance. The objectives of BPR review are to confirm the batch quality and was produced under control. Records of critical steps must be reviewed and approved by quality before release. Failure to comply with cGMPs can render a drug adulterated under the FDA act.
The Product Quality Review (PQR) is a regular review of all licensed medicinal products conducted to verify consistency of manufacturing processes and the appropriateness of specifications. The objectives of the PQR include determining the need for process, specification or validation changes; verifying compliance; identifying trends; and determining corrective actions. The EU requires annual PQRs that review areas like starting materials, process and product testing results, failed batches, deviations, changes made, and stability monitoring results. The PQR is intended to enhance quality and identify improvements.
The document discusses Good Manufacturing Practices (GMP) and contamination prevention. It covers types of contamination, sources, and how to prevent them through practices like personal hygiene, sanitation, cleaning, and equipment maintenance. GMP regulations require facilities, equipment, personnel training, and documentation to help assure product quality and safety.
This document discusses in-process quality assurance in pharmaceutical manufacturing. It defines quality as meeting consumer needs and outlines how quality is built into the manufacturing process through controls like following good manufacturing practices, input material control, process control, in-process checks, cross-checking, and product release controls. The document explains that in-process quality assurance is important to ensure products are consistently manufactured to quality standards by guiding operators about any deviations observed during production. It provides examples of in-process checks for various unit operations like blending, compression, and coating. The overall goal of in-process quality assurance is to reduce batch rejections and reprocessing by adopting controls that build quality into each stage of the manufacturing process.
This document discusses process validation for solid oral dosage forms such as tablets and capsules. It begins by defining process validation and outlining the types, including prospective, concurrent, and retrospective validation. For tablets, it covers validation of raw materials, analytical methods, equipment, and process parameters. For capsules, it discusses validation of the capsule composition, encapsulation process, and quality control tests. The conclusion emphasizes that validation ensures reproducibility and compliance.
Line clearance is an important procedure to prevent mix-ups and mistakes during manufacturing. It involves three stages: clearing, cleaning, and checking. During clearing, materials from the previous production are removed. Next, cleaning is done according to standard operating procedures. Finally, the line is checked and any issues are recorded before clearance is given to begin the next production. Line clearance must be performed before various stages of production such as dispensing, filling, packaging, and more. It helps ensure safety and quality in manufacturing.
This document discusses changeover clearance, which is a process to ensure an area is free of residue before a new process. It describes minor changeovers between batches of the same product and major changeovers between different products. The types of changeovers and responsible personnel are defined. Key aspects of changeover clearance include cleaning equipment and areas, ensuring correct documentation, and labeling. Changeover clearance helps prevent mix-ups and contamination between products to maintain quality. The document stresses the importance of proper changeover clearance procedures.
c gmp (current good manufacturing practices)Rohit K.
cGMP (Current Good Manufacturing Practices) regulations provide the framework for ensuring quality control during pharmaceutical manufacturing. The regulations are divided into parts 210 and 211. Part 211 addresses good manufacturing practices for finished pharmaceuticals and is further divided into 11 subparts covering organization, facilities, equipment, production, packaging, labeling, quality control, and more. The goal of cGMP is to ensure identity, strength, quality and purity of drugs through strict control of manufacturing and monitoring.
The document discusses validation in pharmaceutical manufacturing. It defines validation and equipment qualification, which includes design qualification, installation qualification, operational qualification, and performance qualification. The goals of equipment qualification are to ensure equipment works correctly and produces accurate results through documentation and control of any changes. Specific validation processes for an autoclave used in stem sterilization are also outlined.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
This document discusses cross-contamination, mix-ups, and clean room practices. It defines key terms like contamination, cross-contamination, and mix-ups. It identifies sources of contamination like personnel, equipment, airflow, and discusses prevention methods like facility design, cleaning validation, and cleanroom classification systems. Personnel clothing, hygiene, and cleaning practices are important to prevent contamination from people. Proper airflow and HVAC systems also help control contamination. Regular monitoring and maintenance of cleanrooms is necessary to ensure quality manufacturing of pharmaceutical products.
The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers to using the most up-to-date production processes and technologies to comply with regulations, as defined by the FDA. Regulatory agencies that establish GMP standards are mentioned, along with the objectives of GMP and specific guidelines covering quality management, personnel, facilities, equipment, documentation, and production records.
This presentation from the Institute of Validation Technology's 7th Annual Method Validation covers regulatory expectations for deviations and out-of-specification results and protocol exceptions, change control, handing investigations and CAPAs, and avoiding common pitfalls.
GMP (good manufacturing practices) and cGMP (current good manufacturing practices) are quality standards for the manufacture of pharmaceutical products and medical devices. They help ensure that products are consistently produced and controlled according to quality standards for safety and efficacy. Key aspects of GMP include establishing processes and procedures for production, cleaning, maintenance, personnel training, and quality testing of products. Following GMP guidelines helps manufacturers produce pharmaceuticals that meet the necessary quality standards.
GMP regulations provide minimum standards for pharmaceutical manufacturing to ensure consistent high quality, safety, and efficacy of medicines. Key aspects of GMP include having documented procedures, validated processes, qualified facilities and equipment, trained personnel, cleaning and maintenance programs, quality control testing, and compliance auditing. Following GMP helps manufacturers produce pharmaceuticals that meet marketing authorizations and protects public health.
This document discusses the process validation of capsules. It begins by providing background on validation and defining process validation according to the FDA. It then describes the three main types of process validation: prospective, concurrent, and retrospective. Key documents used in validation like the validation master plan, validation protocols and reports, and standard operating procedures are also outlined. The validation process for capsules is then detailed, including evaluating the capsule composition, selecting the encapsulation process and equipment, and testing the encapsulation step. Critical factors considered during encapsulation like the technique used and encapsulation speed are also summarized.
This document discusses vendor audits for packaging materials. It defines a vendor audit as a way for pharmaceutical companies to inspect and evaluate a vendor's quality management system and practices. The objectives of a vendor audit are to ensure contracts are executed properly and identify risks, cost savings, and process improvements. The document outlines key steps in conducting a vendor audit, including preparing an audit plan, inspecting facilities and documentation, and writing an evaluation report. It also provides details on auditing packaging material vendors, such as checking storage areas, materials, and supplier qualifications.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
This document discusses the qualification of manufacturing equipment. It explains that equipment qualification is necessary to ensure equipment works correctly and produces reliable results. There are four types of qualification: design, installation, operational, and performance. Design qualification defines equipment specifications. Installation qualification confirms proper installation. Operational qualification verifies equipment functions as specified. Performance qualification demonstrates consistent performance under routine use. The document then provides details on specific qualification procedures for dry powder mixers and fluidized bed dryers.
WHO GMP- Introduction to the Training Course-1Jony Mallik
This document outlines an introductory training course on basic principles of Good Manufacturing Practice (GMP). The course objectives are to introduce elements of quality management and train participants in WHO GMP texts. It will cover topics like quality management, sanitation, and sterile production over several modules. Participants will work in groups to discuss issues, set objectives for attending, and provide feedback. The goals are for participants to bring experience, develop action plans, and gain a shared understanding of GMP principles.
This presentation is produced in the DigiCare project go-funded by Erasmus+ Capacity Building for Higher Education, CBHE.
This is the eighth of ten learning packages produced in the DigiCare project as support materials for implementing the DigiCare model and supporting teachers with ready-made materials.
The learning packages are designed to be adaptable to the specific needs of each Higher Education Institution (HEI) and healthcare student group. While they provide essential information, they are not exhaustive in their coverage. Active pedagogical tools are incorporated into the packages, which can be employed during theory lessons. Each presentation includes a Notes section below the slides, offering ideas for teachers and recommendations for further reading.
The learning packages can be translated, edited, and supplemented with additional content as desired. The packages can be used as a complete set or individually, based on the specific requirements of users. Each learning package is accompanied by an introductory slides and the final slide provides information about the subsequent package in the series.
This document discusses process validation for solid oral dosage forms such as tablets and capsules. It begins by defining process validation and outlining the types, including prospective, concurrent, and retrospective validation. For tablets, it covers validation of raw materials, analytical methods, equipment, and process parameters. For capsules, it discusses validation of the capsule composition, encapsulation process, and quality control tests. The conclusion emphasizes that validation ensures reproducibility and compliance.
Line clearance is an important procedure to prevent mix-ups and mistakes during manufacturing. It involves three stages: clearing, cleaning, and checking. During clearing, materials from the previous production are removed. Next, cleaning is done according to standard operating procedures. Finally, the line is checked and any issues are recorded before clearance is given to begin the next production. Line clearance must be performed before various stages of production such as dispensing, filling, packaging, and more. It helps ensure safety and quality in manufacturing.
This document discusses changeover clearance, which is a process to ensure an area is free of residue before a new process. It describes minor changeovers between batches of the same product and major changeovers between different products. The types of changeovers and responsible personnel are defined. Key aspects of changeover clearance include cleaning equipment and areas, ensuring correct documentation, and labeling. Changeover clearance helps prevent mix-ups and contamination between products to maintain quality. The document stresses the importance of proper changeover clearance procedures.
c gmp (current good manufacturing practices)Rohit K.
cGMP (Current Good Manufacturing Practices) regulations provide the framework for ensuring quality control during pharmaceutical manufacturing. The regulations are divided into parts 210 and 211. Part 211 addresses good manufacturing practices for finished pharmaceuticals and is further divided into 11 subparts covering organization, facilities, equipment, production, packaging, labeling, quality control, and more. The goal of cGMP is to ensure identity, strength, quality and purity of drugs through strict control of manufacturing and monitoring.
The document discusses validation in pharmaceutical manufacturing. It defines validation and equipment qualification, which includes design qualification, installation qualification, operational qualification, and performance qualification. The goals of equipment qualification are to ensure equipment works correctly and produces accurate results through documentation and control of any changes. Specific validation processes for an autoclave used in stem sterilization are also outlined.
Validation: Validation is a documented program that provides high degree of assurance that a specific process, method or system consistently produces a result meeting pre-determined acceptance criteria.
This document discusses cross-contamination, mix-ups, and clean room practices. It defines key terms like contamination, cross-contamination, and mix-ups. It identifies sources of contamination like personnel, equipment, airflow, and discusses prevention methods like facility design, cleaning validation, and cleanroom classification systems. Personnel clothing, hygiene, and cleaning practices are important to prevent contamination from people. Proper airflow and HVAC systems also help control contamination. Regular monitoring and maintenance of cleanrooms is necessary to ensure quality manufacturing of pharmaceutical products.
The document discusses Good Manufacturing Practices (GMP) guidelines according to ICH Q7A. It states that both GMP and cGMP aim to prevent bad quality products from entering the market. GMP applies to pharmaceutical and healthcare products, while cGMP refers to using the most up-to-date production processes and technologies to comply with regulations, as defined by the FDA. Regulatory agencies that establish GMP standards are mentioned, along with the objectives of GMP and specific guidelines covering quality management, personnel, facilities, equipment, documentation, and production records.
This presentation from the Institute of Validation Technology's 7th Annual Method Validation covers regulatory expectations for deviations and out-of-specification results and protocol exceptions, change control, handing investigations and CAPAs, and avoiding common pitfalls.
GMP (good manufacturing practices) and cGMP (current good manufacturing practices) are quality standards for the manufacture of pharmaceutical products and medical devices. They help ensure that products are consistently produced and controlled according to quality standards for safety and efficacy. Key aspects of GMP include establishing processes and procedures for production, cleaning, maintenance, personnel training, and quality testing of products. Following GMP guidelines helps manufacturers produce pharmaceuticals that meet the necessary quality standards.
GMP regulations provide minimum standards for pharmaceutical manufacturing to ensure consistent high quality, safety, and efficacy of medicines. Key aspects of GMP include having documented procedures, validated processes, qualified facilities and equipment, trained personnel, cleaning and maintenance programs, quality control testing, and compliance auditing. Following GMP helps manufacturers produce pharmaceuticals that meet marketing authorizations and protects public health.
This document discusses the process validation of capsules. It begins by providing background on validation and defining process validation according to the FDA. It then describes the three main types of process validation: prospective, concurrent, and retrospective. Key documents used in validation like the validation master plan, validation protocols and reports, and standard operating procedures are also outlined. The validation process for capsules is then detailed, including evaluating the capsule composition, selecting the encapsulation process and equipment, and testing the encapsulation step. Critical factors considered during encapsulation like the technique used and encapsulation speed are also summarized.
This document discusses vendor audits for packaging materials. It defines a vendor audit as a way for pharmaceutical companies to inspect and evaluate a vendor's quality management system and practices. The objectives of a vendor audit are to ensure contracts are executed properly and identify risks, cost savings, and process improvements. The document outlines key steps in conducting a vendor audit, including preparing an audit plan, inspecting facilities and documentation, and writing an evaluation report. It also provides details on auditing packaging material vendors, such as checking storage areas, materials, and supplier qualifications.
This document discusses handling deviations from standard operating procedures in quality management systems. It defines a deviation as any departure from approved instructions or established standards. Deviations are classified as either planned or unplanned. Unplanned deviations require investigation to determine the root cause and implement corrective and preventive actions. The investigation process involves documenting the event, taking immediate action, analyzing the root cause, implementing corrective actions, and evaluating effectiveness. Guidelines such as ICH Q7 provide requirements for deviation handling, investigation, and corrective action to prevent future deviations.
This document discusses the qualification of manufacturing equipment. It explains that equipment qualification is necessary to ensure equipment works correctly and produces reliable results. There are four types of qualification: design, installation, operational, and performance. Design qualification defines equipment specifications. Installation qualification confirms proper installation. Operational qualification verifies equipment functions as specified. Performance qualification demonstrates consistent performance under routine use. The document then provides details on specific qualification procedures for dry powder mixers and fluidized bed dryers.
WHO GMP- Introduction to the Training Course-1Jony Mallik
This document outlines an introductory training course on basic principles of Good Manufacturing Practice (GMP). The course objectives are to introduce elements of quality management and train participants in WHO GMP texts. It will cover topics like quality management, sanitation, and sterile production over several modules. Participants will work in groups to discuss issues, set objectives for attending, and provide feedback. The goals are for participants to bring experience, develop action plans, and gain a shared understanding of GMP principles.
This presentation is produced in the DigiCare project go-funded by Erasmus+ Capacity Building for Higher Education, CBHE.
This is the eighth of ten learning packages produced in the DigiCare project as support materials for implementing the DigiCare model and supporting teachers with ready-made materials.
The learning packages are designed to be adaptable to the specific needs of each Higher Education Institution (HEI) and healthcare student group. While they provide essential information, they are not exhaustive in their coverage. Active pedagogical tools are incorporated into the packages, which can be employed during theory lessons. Each presentation includes a Notes section below the slides, offering ideas for teachers and recommendations for further reading.
The learning packages can be translated, edited, and supplemented with additional content as desired. The packages can be used as a complete set or individually, based on the specific requirements of users. Each learning package is accompanied by an introductory slides and the final slide provides information about the subsequent package in the series.
The A.D.D.I.E. of Developing a Strategic Training RoadmapHenry John Nueva
Whatever size business you run, it is important to remember that learning is an ongoing experience. This applies as much to the upper management of the business as the employees.
It follows that training should also be a part of the company’s day to day business activities. Of course, employees who are motivated and keen to see the business succeed will often take new ideas that they come across during the course of their work, and will sometimes be in a position to make suggestions for improvement that can benefit the company’s bottom line. Check this out !
NAP Training Viet Nam - Session 8 Moving Toward ActionsUNDP Climate
This two-day workshop supported the Government of Viet Nam in building the necessary capacity to advance its National Adaptation Plan (NAP) process. The workshop closely focused on building National Adaptation Plans in the agricultural sector through multi-stakeholder collaboration, and increased knowledge and capacity on a number of topics including: prioritization of adaptation options, cost-benefit analysis, overview of the broad-based nature of climate change adaption impacts, analysis of challenges, and creation of an open discussion with key stakeholders on defining a road-map for the NAP process. The workshop was delivered using discussions and case studies to enhance interactive learning for participants, with supporting presentations by GiZ and SNV.
This presentation is produced in the DigiCare project go-funded by Erasmus+ Capacity Building for Higher Education, CBHE.
This is the ninth of ten learning packages produced in the DigiCare project as support materials for implementing the DigiCare model and supporting teachers with ready-made materials.
The learning packages are designed to be adaptable to the specific needs of each Higher Education Institution (HEI) and healthcare student group. While they provide essential information, they are not exhaustive in their coverage. Active pedagogical tools are incorporated into the packages, which can be employed during theory lessons. Each presentation includes a Notes section below the slides, offering ideas for teachers and recommendations for further reading.
The learning packages can be translated, edited, and supplemented with additional content as desired. The packages can be used as a complete set or individually, based on the specific requirements of users. Each learning package is accompanied by an introductory slides and the final slide provides information about the subsequent package in the series.
FAO - 3. planning for producers associationsHernani Larrea
The Minami-Satsuma Agricultural Cooperative in Japan has over 12,000 member farmers producing a variety of crops including green tea, pumpkins, sweet potatoes, rice, vegetables, and livestock. As a large cooperative, it provides services to members such as farm advisory support, input supply, and output marketing. It has also expanded into international markets through strategies like pre-cooking and freezing vegetables to penetrate markets in Asia and the United States.
This guide provides materials for conducting monitoring and evaluation training sessions ranging from 1.5 hours to 2 days, including session agendas, exercises, and instructions for facilitators. It offers guidance on preparing for and adapting the training sessions to meet participant needs. The materials are meant to help trainers and participants better understand the concepts of monitoring and evaluation in the UNDP results framework.
Silvana Richardson: Weighing the Pig Doesn't Make it Fatter or Does iteaquals
This document discusses evaluating continuing professional development (CPD) programs using Guskey's five levels of evaluation. It begins by establishing the importance of evaluation in determining a CPD offer's impact. Level 1 evaluates participants' reactions; Level 2, learning; Level 3, organizational support for change; Level 4, application of new knowledge and skills; and Level 5, students' learning outcomes. Various tools are provided for each level. The document encourages considering all levels and discusses challenges, like timing. It concludes by having participants reflect on their organization's evaluation practices and how to strengthen them.
The document describes a trainer's module for a workshop on shared decision making. It provides guidance to trainers on preparing to conduct their own trainings, which includes: developing a training plan; compiling materials for participants; marketing the training; and ensuring participants can receive continuing education credits. The goal is to train healthcare professionals in shared decision making and provide ongoing support through an online learning network and webinars.
Report on Fab Labs and Sustainable Development Goals; Workshop; FAB13 Confere...Pieter van der Hijden
FAB13 Workshop: Fab Labs and Sustainable Development Goals (Sustainable Fab Lab Goals / Objetivos de Fab Labs Sostenibles); Report on the workshop during FAB13 conference in Santiago de Chile; 2017; Pieter van der Hijden, Enrico Bassi, Vaneza Caycho Ñuflo, Neville Govender, Yogesh Kulkarni, Wendy Neale.
This document outlines learning outcomes and tasks for an L5 PreProduction Specialist Study course in 2011. It discusses Kolb's learning cycle and conducting a self-assessment of skills and areas for improvement. The four learning outcomes focus on: 1) conducting research in a specialist area, 2) presenting work methodology verbally and visually, 3) identifying and engaging a target audience through design principles, and 4) demonstrating professional responsibility through on-time task completion. Students are assigned research, documentation, and presentation tasks to prepare for an L6 Specialist Study course, including developing an Area of Practice and action plan, and presenting their skills and offerings to potential L6 partners.
This document provides an overview and session plans for a training module on basic communication skills for trainers. The module aims to help participants improve their presentation, demonstration, discussion facilitation and training method selection skills over the course of 6 sessions. Each session plan outlines the objectives, activities, training aids and timing. Evaluation methods include self-assessment, observation, feedback and a post-module questionnaire. The document includes supporting materials like a trainer checklist, sample presentation evaluation forms, and discussion techniques guides.
This document provides an overview of a trainer's module for conducting shared decision making trainings. It outlines:
- How to prepare for trainings, including creating an agenda, compiling materials, and contacting trainees.
- Elements to include when planning trainings such as format, timing, location, and marketing strategies.
- Additional resources available to support trainings including an online learning network, webinars, and technical assistance.
- Information on acquiring continuing education credits for the trainer's workshop and future trainings conducted by trainees.
This document provides an overview of a trainer's module for teaching the SHARE Approach, which involves shared decision making. It outlines the topics that will be addressed in the training, including how to prepare for and conduct trainings, compile materials, market the training, and help participants obtain continuing education credits. The goal of the train-the-trainer program is to enable participants to train colleagues in shared decision making and engage leadership at their organizations. The training will cover planning workshops, available resources, and ongoing support through an online learning network and webinars.
The document provides guidance for training village facilitators to lead a participatory planning process to address HIV/AIDS at the village level. It outlines 11 units that will train facilitators on gathering community input, developing a theatre performance to raise awareness, creating an HIV/AIDS behavior change plan, and implementing and monitoring the plan. The first 2 units cover initial preparations that must be made by various stakeholders at the district, ward and village levels in advance of community meetings.
This document outlines a workshop on designing great lectures using the Deming cycle. The workshop objectives are to help participants recognize elements of a great lecture, design objectives, discuss teaching methods, engage students, and avoid mistakes. It discusses planning a lecture by understanding the audience and objectives, organizing content, using strategies like questions to engage students, and delivering effectively. It also covers checking learning through assessments, getting student feedback, and continually improving lectures based on the results.
This document provides an introduction and facilitator's guide for a regional skills-building workshop on monitoring, evaluation, and knowledge management of programs to end violence against women and girls. The workshop aims to provide grantees of the UN Trust Fund with skills in evidence-based programming, monitoring and evaluation, and knowledge management. It is designed to be interactive, utilizing participants' experiences and case studies. The five-day workshop covers topics such as developing program goals and objectives, monitoring and evaluation frameworks, choosing indicators, quantitative evaluation designs, and methods for measuring violence against women programs.
Does Over-Masturbation Contribute to Chronic Prostatitis.pptxwalterHu5
In some case, your chronic prostatitis may be related to over-masturbation. Generally, natural medicine Diuretic and Anti-inflammatory Pill can help mee get a cure.
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
Dive into an in-depth exploration of the histological structure of female reproductive system with this comprehensive lecture. Presented by Dr. Ayesha Irfan, Assistant Professor of Anatomy, this presentation covers the Gross anatomy and functional histology of the female reproductive organs. Ideal for students, educators, and anyone interested in medical science, this lecture provides clear explanations, detailed diagrams, and valuable insights into female reproductive system. Enhance your knowledge and understanding of this essential aspect of human biology.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
share - Lions, tigers, AI and health misinformation, oh my!.pptxTina Purnat
• Pitfalls and pivots needed to use AI effectively in public health
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• Assessing risk and mitigating harm from adverse health narratives in communities, health workforce and health system
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
Hiranandani Hospital in Powai, Mumbai, is a premier healthcare institution that has been serving the community with exceptional medical care since its establishment. As a part of the renowned Hiranandani Group, the hospital is committed to delivering world-class healthcare services across a wide range of specialties, including kidney transplantation. With its state-of-the-art facilities, advanced medical technology, and a team of highly skilled healthcare professionals, Hiranandani Hospital has earned a reputation as a trusted name in the healthcare industry. The hospital's patient-centric approach, coupled with its focus on innovation and excellence, ensures that patients receive the highest standard of care in a compassionate and supportive environment.
2. Module 1 | Slide 2 of 17 January
2006
Basic Principles of GMP
Introduction
to the Training Course
3. Module 1 | Slide 3 of 17 January
2006
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
4. Module 1 | Slide 4 of 17 January
2006
Introduction
Programme Overview – I
Basic Principles of GMP
WHO Technical Report Series, No. 908, 2003, Annex 4
1. Introduction to the training programme
2. Quality Management
3. Sanitation and hygiene
4. Qualification and Validation
5. Complaints and recalls
5. Module 1 | Slide 5 of 17 January
2006
Introduction
Programme Overview – II
Basic Principles of GMP
6. Contract production and analysis
7. Self Inspection and quality audits
8. Personnel
9. Premises
10. Equipment
6. Module 1 | Slide 6 of 17 January
2006
Introduction
Programme Overview – III
Basic Principles of GMP
11. Materials
12. Documentation
13. Good Practices in production and quality control
14. Sterile production
15. Active pharmaceutical ingredients
7. Module 1 | Slide 7 of 17 January
2006
Introduction
Programme Overview – IV
GMP Inspection Process
16. Introduction
17. The role of the inspector
18. Preparation for the inspection
19. Types of GMP inspection
20. The inspection
Trainers’ notes
8. Module 1 | Slide 8 of 17 January
2006
Introduction
Your Team
Who are we?
Trainers
(Name)
(Qualifications)
(Experience)
(Name)
(Qualifications)
(Experience)
9. Module 1 | Slide 9 of 17 January
2006
Introduction
Who am I?
Name
Experience
Objectives
Not a lot of people know ………..
10. Module 1 | Slide 10 of 17 January
2006
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
11. Module 1 | Slide 11 of 17 January
2006
Introduction
Our Way of Working
A presentation on the subject of the module - usually about
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 minute group session discussing issues or a problem that
will be set for you
Group feedback in plenary session
Multiple choice quiz
12. Module 1 | Slide 12 of 17 January
2006
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
needs 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
13. Module 1 | Slide 13 of 17 January
2006
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
14. Module 1 | Slide 14 of 17 January
2006
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”
15. Module 1 | Slide 15 of 17 January
2006
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
Organizational level
Personal level
16. Module 1 | Slide 16 of 17 January
2006
Introduction
Group Session
Identify key objectives to be achieved in attending this programme, at
a Regional level, at a National level, at an Organizational level and at
a Personal level.
Set objectives using the SMART formula:
Specific
Measurable
Action-oriented
Realistic
Time-related
17. Module 1 | Slide 17 of 17 January
2006
Introduction
Group Session
Identify key objectives to be achieved in attending this programme, at
a Regional level, at a National level, at an Organizational 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
Editor's Notes
Welcome
Good morning and welcome to all delegates to this training course offered by the World Health Organization to develop the practical implementation of the WHO GMP text of Good Manufacturing Practice for Pharmaceutical Products.
Thanks
Our thanks to ______________________ for the arrangements that have been made to accommodate us all for the duration of the programme.
Housekeeping
(cover fire or emergency procedures, and domestic arrangements including location of toilet facilities, tea or coffee breaks, meal breaks)
Objectives
I propose to review first of all the objectives that have been established for this training programme. These are to outline the programme and to describe the qualities that your team members bring to the programme.
(Introduce trainers)
We would also find it most valuable if we could understand something about you, why you are here and what you want to get from this training programme. In this way we hope to ensure that you get what you want from the programme. Additionally it will help us and your fellow trainees to know your area of expertise, so that we may all learn from one another.
It is also important that you have an understanding of how the modules are constructed, and our way of working in groups. I will explain a little later about some team rules which are essential if you are to obtain the most benefit from this GMP course.
My colleagues and I are also available to be consulted individually on any matter if you feel we can help in any way. Please make maximum use of the opportunity to exchange experiences with all of us.
We shall start by reviewing the programme and introduce our interactive way of working together. We will explain the way the group discussions will work.
Modules 1-14 cover the basic principles of GMP.
There will be a half-day module on Quality Management and the requirements for a quality assurance unit. You will need to have a clear understanding of the organizational structures that must be in place if a pharmaceutical company is to have the product quality that is required by the National Health Regulator.
We shall look at complaint handling procedures and product recall procedures that you should expect pharmaceutical companies to have. This ensures that complaints are properly handled and that patients are protected from dangerous or substandard medicines that have been placed on the market by a proper recall system.
This will be followed by a half-day session on Sanitation and Hygiene.
Next we will spend a half-day looking at Validation.
We then have a half-day module on Contract Production and Analysis. This is becoming much more important all over the world as companies decide not to manufacture all their own products in their own factories or manufacturing sites. This means that companies are putting more and more work out to contractors. Companies are also contracting out analytical work as methods become more complex or use expensive equipment. All of this contract work requires careful your inspection.
Next we will have a short session on Self-inspection.
We then turn to the topic of Personnel. Personnel should be seen by the pharmaceutical manufacturer as its most valuable resource. It is sometimes its most difficult one to manage. Inspectors need to be sure that there are sufficient human resources, with people who have the correct qualifications and acceptable levels of experience. An important issue for you to check is the conflict of interest that can arise if Quality Control is not properly independent of Production. For this reason a full day is required for this subject.
This will be followed by a half-day session on Equipment. If you would like to have any particular piece of equipment discussed please write its name down and hand it to me at the end of this module. If possible we will discuss the item during the Equipment module.
We shall then spend a full day on Premises. Here we are going to be looking at some of the fundamental issues, including the effect of the external environment, on a company’s ability to manufacture products in the appropriate conditions.
This will be followed by a half-day session on Materials. Experience has shown that many problems arise as a result of the selection of unsuitable or impure materials. Many developing countries have financial constraints that work against using materials of the right quality.
Documentation: This short module covers the design and use of documentation -- often poorly done, especially in less developed countries. Correct recording of activities as they occur is vital for the production and testing of products to meet GMP standards.
The full-day module on Sterile Production will look at the very demanding activities required to achieve the highest standards. There are special demands that these very important products make upon a company’s resources and systems. Companies are often tempted to take shortcuts because of the expense involved and you will have to know where to look to see if the companies are strictly following Good Manufacturing Practices.
A half-day module on Active Pharmaceutical Ingredients is covered next. This is an area where regulatory authorities should be increasing their inspection activities. It is a vital area for proper drug efficacy. If poor quality actives are used then the drug attributes sometimes cannot be tested for later on when the material is compounded into product. A problem at a later stage is also more expensive to detect and correct.
Personal objectives: On completion of the GMP Basic Training Modules, we shall distribute a Personal Action Plan form in order to check your understanding of the materials, and to give you the opportunity to develop your personal action plans.
Modules 15-20 cover the G MP Inspection Process. Modules 15-19 consist of short sessions on:
. an introduction to the topic
. the role of the inspector
. preparation for the inspection
. types of GMP inspection
. the inspection
and will take approximately one-and-a-half days to complete.
Module 20 provide trainer’s notes.
THIS SLIDE (or overhead transparency) IS AN EXAMPLE ONLY AND HAS NOT BEEN PROVIDED IN THE PACK – YOU SHOULD PREPARE AN APPROPRIATE VERSION FOR EACH COURSE.
First of all a few details about each of your team members.
(The team members are to introduce themselves with a short review of their background and experience, giving training, qualifications, organizations worked with, and any other relevant details. Get them to also reveal something personal, such as a hobby.)
(Note to the trainer: This is a good ice-breaker. Get the trainees used to speaking to the whole group. Give each trainee only 2 or 3 minutes each, a little longer if at all possible. You may need to allow a little for time depending on the language ability of the participants.)
In order that we can all become better acquainted, I would like you to tell us your name, your experience to date in manufacturing and/or GMP inspection, your objectives for attending this training programme and a little something about you that no one else in the room knows – YET!
When we were preparing for this training programme, we were aware that it had to be of value to you, our participants. We felt very strongly that it must provide information and experience sharing in a form that you will want to take away with you and use again and again.
These are the objectives that we have for this programme:
We aim to provide you with a training programme to ensure that you have an understanding of all aspects of the WHO recommendations on GMP for pharmaceutical products. However, these recommendations have to be applied in the real world in which you live. For this reason we have developed the programme in such a way that your input will be an important element.
The programme has been designed to enable you to bring in your real life experiences, so that we can see how you will respond to these real challenges.
A training programme is only of value if, as a result of the training, you change your behaviour. To encourage such a change, we will be asking you to prepare your own personal action plan as we work through the training.
Note for the trainer: The form for the action plan should be contained in the trainee’s registration material. It is suggested that you have an overhead of this and go through its layout at this point
You have each been provided with a form for your own personal action plan: things to do as a result of this training programme. If any of you would like help in creating this action plan please see any member of the team during training. We would recommend that you compile this plan as we go along and not leave it all to the end.
You will be expected to discuss this action plan with your supervisor on your return to your office and then regularly to review your progress with him or her.
The modules start with a presentation which follows the WHO text. A reference number to the WHO text is always given in a text box at the bottom of the slide.
There follows a group discussion. We have placed you into small groups and designated a room or an area for you to work in. On the next slide we will talk about the most effective ways to have a group discussion.
Each group will be asked to present its findings before the other groups in what is sometimes referred to as a plenary session. We will allow 5 - 10 minutes for each group to make its presentation.
At the end of each of the modules on Basic Principles of GMP (except this one) there is a set of simple multiple choice questions to complete. We will then go through the answers with you and discuss any questions you may have about them. Many previous groups have found test answer session one of the most informative parts of the programme.
At the end of each session on the theory of the WHO text, we will put up an overhead to remind you which group you are in, which area or room you should go to, and the key issues to be discussed.
Please help us to keep to time by moving quickly to your area.
Your group must first appoint a chairperson, a timekeeper to keep you on track, a recorder and someone to present your conclusions.
Then discuss the issues.
These group discussions are considered to be:
fundamental to the learning process
need enthusiastic participation
needs a “brainstorming approach
We recommend the technique of “brainstorming” using a flip-chart to get all the issues out into the open quickly. I should just like to check if everyone is familiar with brainstorming and the rules that apply to it.
(Note to the trainer: If necessary advise how brainstorming is undertaken using a flipchat.)
At the end of your group discussions, you will come back here for a session at which the conclusions from each group will be presented to everyone. This will last at the most, 30 minutes.
Some trainees may get suppressed by more dominating trainees. A few group rules are useful. Trainers tip: Provide slides 11 and 12 as fullpage handouts.
Dialogue: make sure that the groups are not monopolized by one participant
Shared ideas: encourage participants to share experiences or to advance their ideas even if they seem a little silly. Make sure that they record all ideas, no matter how strange they may seem. Some explanation of brainstorming may be needed.
Shared understanding: some participants in each group may have a good understanding of the subject and should be encouraged to explain the concepts.
Shared meaning: If some of the group has a better understanding of the meaning of a concept, encourage them to share this with the group.
Clarifying: make clear the meanings
Participation: Each person should be encouraged to participate in the groups work.
Enabling others to participate: Some participants through shyness of language barriers may feel left out. It is important that the groups draw these people into the discussions as much as possible.
Active listening means concentrating on what they are saying, asking questions such as “I take it that you mean … by your statement”, or “I see” or “could you explain that another way perhaps”
Agreeing to disagree: sometimes, inevitably, there comes a time when some people within a group just cannot agree. This is sometimes quite acceptable because GMP is not a black and white subject. However, it is important that when this situation arises that the people respect that the other person has a right to hold a certain interpretation and so still agree to disagree.
Its OK to disagree within a group. However, try to understand the other person’s point of view.
Trainer’s tip: this slide may have to be ordered with the Personal level coming first, depending on the nature and background of the participants. The Regional and National level may have to be explained or a global perspective can sometimes be encouraged where there are countries with factories are exporting (or want to export) products around the world.
For our first group session we want to you to familiarize yourself with the brainstorming technique and the way of working in groups. You need to learn how to work with your groups members to achieve a good result together. Please use this session to start this process.
Your task in your groups is to to discuss the current GMP situation in your country.
We wish to know the following:
1. What do you consider to be your key objectives for this programme?
2. What you will use to measure the success or otherwise of the whole programme?
Discuss the SMART approach to setting objectives. Example: I want to prepare two GMP training modules for use in my own country by the year 2003. Show how this is specific, measurable, action-oriented, realistic and time based.
Identify 3 criteria by which you will measure the effect.
You have 1 hour for this activity and you should return with 1 flip-chart sheet to be presented in a maximum of 5 - 10 minutes (Note: you may have to allow a little longer for discussion or for other matters such as language problems) in the plenary session.
Here is a list of the members of each group and your group room numbers. You have one hour for the discussion and then we shall meet back here for the group feedback session. We hope that you will enjoy our training programme and gain valuable insights that will help you in your work in the future.