19 Courses

Course Information This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks. Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings. Is this course for you? Ideal for professionals engaged in GMP across various sectors, including: Research and Development (R&D) Contract Manufacturing Organisations Manufacturing Units Quality Control (QC) Laboratories Auditing Roles. What will you learn? Event objectives - by the end of the course, delegates shall: Have an awareness of the basic requirements of GMP Be aware of UK and EU GMP Rules and Guidance and relevant publications Understand the roles and responsibilities associated with GMP Be able to contribute to and maintain quality documentation Have a basic understanding of product lifecycle and manufacturing Understand the requirements of GMP in the QC laboratory context Have a basic understanding of risk management and mitigation principles Understand the need for quality systems and quality assurance activities Be aware of common regulatory findings. Learning outcomes: delegates will be able to: Implement their role within GMP with confidence and knowledge of the principle requirements Contribute effectively to the GMP quality system and their organisation’s compliance Comprehend where their organisation’s activities sit within the larger GMP arena Know where to seek further information within the published rules and guidance, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 09:30 Introductions and Scope of the Course Understand the group requirements and the tutor's background and experience. 09:45 Background and Regulatory Environment Setting the scene, understanding the context, key legislation. 10:30 Principles of GMP Key points and requirements. 11:15 Break 11:30 Personnel and Responsibilities Management and staff, duties and accountabilities. 12:00 Overview of GMP Manufacturing Basics of the product life cycle. 12:30 Lunch 13:15 Risk Management Workshop Practical exploration of risk and mitigation activities. 14:30 QC Laboratories Activities and practicalities. 15:15 Break 15:30 Compliance Quality Assurance and Self Inspection. 16:15 Question Time A chance for questions on the practicalities of GMP. 16:30 Close of Course Extra Information Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 7 Points   Development Level Learn

Healthcare is a sector where medical knowledge is necessarily in focus. The management system shall take this into account when determining the approaches applied. Knowledge management of the clinical processes is the general approach for operational application of medical knowledge. Maintaining medical knowledge is a requirement related to personal competence for the staff of the organization. Systematic approaches to develop and maintain medical knowledge are requirements related to resource management. – BS EN 15224:2016

Our Legionella/Water Quality Risk Management – General Awareness course offers a basic introduction to Legionnaires' disease Management and Control.

Has the Computer System Validation Engineer left and you’ve been handed their responsibilities? Do the thoughts of your next audit fill you with dread? CSV can be frustrating but this program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework and ensure compliance with FDA’s 21 CFR Part 11, EU Annex 11 or other regulatory guidelines.

Take our part-time online “Conversion Course into Pharmaceutical Manufacturing“ NO Previous Industry Experience or Science Qualifications Required

AgilePM® Practitioner This course offers preparation for the Practitioner-level examination to gain the APMG-International™ / Agile Project Management Practitioner Certification. Agile Project Management (AgilePM) is the result of collaboration between APMG-International and The DSDM Consortium. DSDM (Dynamic Systems Development Method) is the longest-established Agile method, launched in 1995, and is the only Agile method to focus on the management of Agile projects. The method has evolved over the years and the DSDM Agile Project Framework is the latest version of which AgilePM is a subset. DSDM has always operated predominantly in the corporate environment and has consistently demonstrated its ability to successfully work with and complement existing corporate processes. APMG-International is a global Examination Institute accredited by The APM Group Ltd. It is one of the Examination Institutes accredited by AXELOS. APMG-International has regional offices located in Australia, China, Denmark, Germany, the Netherlands, Malaysia, the United States, and the United Kingdom. Their portfolio of qualifications includes the Best Practice qualifications of ITIL®, PRINCE2®, MSP®, M_o_R®, and P3O®. AgilePM is one of their specialist management qualifications, which also include Change Management and Service Catalogue. The course covers all the Practitioner elements of the AgilePM Handbook v2 with: Clear explanations of the method and practical examples provided by your course tutor Sample exam paper for the Practitioner-level exams to enrich your knowledge and understanding A case study to allow you to practice the application of the method to an agile project The Traditional Classroom option includes the Practitioner exam to provide you with the right opportunity to verify your new skill set by way of a professional qualification The Virtual Classroom option includes a Practitioner exam voucher to allow you to choose the date and time of your online exam to verify your new skill set by way of a professional qualification What You Will Learn You will learn how to: Identify and apply the concepts, tools, and techniques described in Section 2 (Digging Deeper) of the APMG-International's Agile Project Management Handbook (v2.0) to agile projects Tailor and customize AgilePM to suit the needs of different projects Use AgilePM in conjunction with other project management methods such as PRINCE2® Prepare yourself for the Practitioner exam in AgilePM Roles and Responsibilities - The PM View The roles Key project manager relationships Agile Project Management - Through the Lifecycle The DSDM process and the project lifecycle Project management focus phase by phase The Effective Use of Products The products Deliver on Time - Combining MoSCoW & Timeboxing Ensuring effective prioritisation Bringing MoSCoW and timeboxing together People, Teams, and Interactions Effective communication Collaboration Requirements and User Stories What is a requirement? User stories Estimating - How and When Coping with uncertainty Estimating through the lifecycle Project Planning through the Lifecycle Planning in a DSDM project Planning activities phase by phase Quality - Never Compromise Quality What do we mean by quality? Solution and process quality Risk Management Project risk How DSDM helps mitigate project risk Tailoring the Approach The project approach questionnaire Summary and Next Steps

AgilePM® Practitioner: In-House Training This course offers preparation for the Practitioner-level examination to gain the APMG-International™ / Agile Project Management Practitioner Certification. Agile Project Management (AgilePM) is the result of collaboration between APMG-International and The DSDM Consortium. DSDM (Dynamic Systems Development Method) is the longest-established Agile method, launched in 1995, and is the only Agile method to focus on the management of Agile projects. The method has evolved over the years and the DSDM Agile Project Framework is the latest version of which AgilePM is a subset. DSDM has always operated predominantly in the corporate environment and has consistently demonstrated its ability to successfully work with and complement existing corporate processes. APMG-International is a global Examination Institute accredited by The APM Group Ltd. It is one of the Examination Institutes accredited by AXELOS. APMG-International has regional offices located in Australia, China, Denmark, Germany, the Netherlands, Malaysia, the United States, and the United Kingdom. Their portfolio of qualifications includes the Best Practice qualifications of ITIL®, PRINCE2®, MSP®, M_o_R®, and P3O®. AgilePM is one of their specialist management qualifications, which also include Change Management and Service Catalogue. The course covers all the Practitioner elements of the AgilePM Handbook v2 with: Clear explanations of the method and practical examples provided by your course tutor Sample exam paper for the Practitioner-level exams to enrich your knowledge and understanding A case study to allow you to practice the application of the method to an agile project The Traditional Classroom option includes the Practitioner exam to provide you with the right opportunity to verify your new skill set by way of a professional qualification The Virtual Classroom option includes a Practitioner exam voucher to allow you to choose the date and time of your online exam to verify your new skill set by way of a professional qualification What You Will Learn You will learn how to: Identify and apply the concepts, tools, and techniques described in Section 2 (Digging Deeper) of the APMG-International's Agile Project Management Handbook (v2.0) to agile projects Tailor and customize AgilePM to suit the needs of different projects Use AgilePM in conjunction with other project management methods such as PRINCE2® Prepare yourself for the Practitioner exam in AgilePM Roles and Responsibilities - The PM View The roles Key project manager relationships Agile Project Management - Through the Lifecycle The DSDM process and the project lifecycle Project management focus phase by phase The Effective Use of Products The products Deliver on Time - Combining MoSCoW & Timeboxing Ensuring effective prioritisation Bringing MoSCoW and timeboxing together People, Teams, and Interactions Effective communication Collaboration Requirements and User Stories What is a requirement? User stories Estimating - How and When Coping with uncertainty Estimating through the lifecycle Project Planning through the Lifecycle Planning in a DSDM project Planning activities phase by phase Quality - Never Compromise Quality What do we mean by quality? Solution and process quality Risk Management Project risk How DSDM helps mitigate project risk Tailoring the Approach The project approach questionnaire Summary and Next Steps

Develop your skills in agile project management and learn the agile approach using the DSDM® framework. Gain confidence to sit the AgilePM® Foundation and Practitioner qualifications on this accredited programme. Duration: 4 days (26 hours) This accredited course is designed for Project Managers, who require an understanding of the agile approach and/or who are intending to run projects using the DSDM® framework. It is also designed to equip practising Project Managers with the confidence to sit the AgilePM® Foundation and Practitioner qualifications, and each delegate will receive a copy of the Agile Project Management V2 Handbook, published by the Agile Business Consortium, formally known as the DSDM Consortium. Objectives  By the end of the course you will be able to: Demonstrate a detailed, practical knowledge of Agile Project Management, based upon the DSDM framework and be equipped with the ability to apply the agile approach in the workplace Describe how the agile way of working can sit alongside more traditional project management frameworks, such as PRINCE2® Plan, organise and control Agile projects Sit the AgilePM Foundation examination, held on the third day and for the Practitioner examination, held on the afternoon of the fourth day Content Agile fundamentals What is Agile? Choosing an appropriate Agile approach Philosophy, Principles and Project Variables Preparing for Success Roles and responsibilities Roles and Responsibilities and the Project Manager view People, Teams and Interactions The DSDM process and products Looking at the DSDM Process and Project Management through the Lifecycle, as well as the DSDM Products and their Effective Use Practices and control Delivering on Time – combining MoSCoW Prioritisation and Timeboxing Requirements and User Stories Estimating Planning Quality Risk Examination and results Foundation Examination and results Practitioner Workshop and Examination AgilePM® Foundation Exam The AgilePM® Foundation Exam is of 40 minutes duration and consists of 50 multiple choice questions. A Pass is 25 correct answers. The exams are marked by the trainer immediately following the exam and the results are available within an hour. The AgilePM® Practitioner Exam A written paper of 2.5 hours duration. There are 8 Objective Test style questions to be answered in the 2.5 hours and the candidate may use an annotated manual. Each question is worth 10 marks and the candidate must score 40/80 to be successful. Please note that examinations are the responsibility of the examination board, APMG. Presented in association with aims4change, an APMG Accredited Training Organisation. AgilePM®is a Registered Trade Mark of the Agile Business Consortium Limited.

AgilePM® Practitioner: Virtual In-House Training This course offers preparation for the Practitioner-level examination to gain the APMG-International™ / Agile Project Management Practitioner Certification. Agile Project Management (AgilePM) is the result of collaboration between APMG-International and The DSDM Consortium. DSDM (Dynamic Systems Development Method) is the longest-established Agile method, launched in 1995, and is the only Agile method to focus on the management of Agile projects. The method has evolved over the years and the DSDM Agile Project Framework is the latest version of which AgilePM is a subset. DSDM has always operated predominantly in the corporate environment and has consistently demonstrated its ability to successfully work with and complement existing corporate processes. APMG-International is a global Examination Institute accredited by The APM Group Ltd. It is one of the Examination Institutes accredited by AXELOS. APMG-International has regional offices located in Australia, China, Denmark, Germany, the Netherlands, Malaysia, the United States, and the United Kingdom. Their portfolio of qualifications includes the Best Practice qualifications of ITIL®, PRINCE2®, MSP®, M_o_R®, and P3O®. AgilePM is one of their specialist management qualifications, which also include Change Management and Service Catalogue. The course covers all the Practitioner elements of the AgilePM Handbook v2 with: Clear explanations of the method and practical examples provided by your course tutor Sample exam paper for the Practitioner-level exams to enrich your knowledge and understanding A case study to allow you to practice the application of the method to an agile project The Traditional Classroom option includes the Practitioner exam to provide you with the right opportunity to verify your new skill set by way of a professional qualification The Virtual Classroom option includes a Practitioner exam voucher to allow you to choose the date and time of your online exam to verify your new skill set by way of a professional qualification What You Will Learn You will learn how to: Identify and apply the concepts, tools, and techniques described in Section 2 (Digging Deeper) of the APMG-International's Agile Project Management Handbook (v2.0) to agile projects Tailor and customize AgilePM to suit the needs of different projects Use AgilePM in conjunction with other project management methods such as PRINCE2® Prepare yourself for the Practitioner exam in AgilePM Roles and Responsibilities - The PM View The roles Key project manager relationships Agile Project Management - Through the Lifecycle The DSDM process and the project lifecycle Project management focus phase by phase The Effective Use of Products The products Deliver on Time - Combining MoSCoW & Timeboxing Ensuring effective prioritisation Bringing MoSCoW and timeboxing together People, Teams, and Interactions Effective communication Collaboration Requirements and User Stories What is a requirement? User stories Estimating - How and When Coping with uncertainty Estimating through the lifecycle Project Planning through the Lifecycle Planning in a DSDM project Planning activities phase by phase Quality - Never Compromise Quality What do we mean by quality? Solution and process quality Risk Management Project risk How DSDM helps mitigate project risk Tailoring the Approach The project approach questionnaire Summary and Next Steps

PMI-ACP® Exam Prep: In-House Training This course builds on the candidates' practical experience of Agile in the workplace to equip them with the broad range of knowledge and skills required for the PMI® Agile Certification exam. It will follow the PMI® requirements and reference the suggested reading list, including the Agile Practice Guide, but will not be limited to those areas. Within the profession and discipline of project management, Agile continues to develop as a significant and important aspect of bringing change to an organization. Where the products of change must be delivered to the business 'on time,' Agile is often the chosen methodology. In addition to equipping candidates for the PMI® Agile Certification examination, this course will also support candidates in taking a more informed and effective role in Agile projects. It will also enable them to take a significant role in encouraging and enabling the organization to become or develop as an Agile environment. What you will Learn You will learn how to: Appreciate the wider aspects of Agile project management tools and techniques Integrate various disciplines within Agile Tailor / customize Agile to suit the needs of different projects Prepare yourself for the PMI® Agile Certification examination Getting Started Introductions Agenda Expectations Foundation Concepts Defining 'Traditional' Project Management Project management parameters The 'traditional' approach to the parameters Strengths and weaknesses of the traditional approach Defining 'Agile' Project Management Project management parameters revisited The 'agile' approach to the parameters Strengths and weaknesses of agile Managing projects with traditional and agile methods Can the two approaches co-exist? Leveraging the benefits of both methods Options for using both methods on a project Avoiding the elephant traps Key aspects of the PMI® Agile Certified Practitioner (PMI-ACP)® Handbook Overview Eligibility requirements Exam information Exam Blueprint Continuing certification requirements Key aspects of the PMI Agile Certification Examination Content Outline Introduction Agile exam content outline Tools and techniques Knowledge and skills Domains and tasks (not examined) An Introduction to Agile and Implementing Agile Definable work vs. high-uncertainty work Project factors that influence tailoring The Agile Manifesto and 12 Principles Agile mindset Agile domains and tasks Agile Tools and Techniques Related to PM 'Hard Skills' Planning, monitoring, and adapting The need for planning, monitoring, and adapting The Agile approach to planning and plans The Agile planning tools and techniques The Agile monitoring tools and techniques The Agile approach to adapting Product quality A definition of 'product quality' Setting the standard for product quality Agile tools and techniques for achieving product quality Risk management A definition of 'risk' What is 'at risk'? The acceptability of risks The Agile tools and techniques for managing risks Agile Tools and Techniques Related to PM 'Soft Skills' The difference between PM 'hard and soft' skills Communications The importance of communications Forms of agile communications Communications within the project Communications from the project Communications to the project Making communications the cultural norm Interpersonal Skills Defining and understanding management Defining and understanding leadership Defining and understanding servant leadership Delegating vs. empowering Playing to people's strengths Overcoming the roadblocks Core Agile Tools and Techniques The philosophy of core Agile tools and techniques Agile estimation Will traditional forms of estimating work for agile? The relationship between estimating and guessing The relationship between estimating and sizing The where, who, and how of agile estimating Agile analysis and design Product analysis and design from a user point of view Product analysis and design from a supplier point of view Product analysis and design from an agile project point of view Value-Based Agile Tools and Techniques The role of value-based tools and techniques in bridging traditional PM with Agile Value-based prioritization Value-based prioritization and agile projects Investment appraisal methods Regulatory driven Customer driven Ranking methods (MMF, MoSCoW) Metrics What should we measure / track? Methods of measuring / tracking Adding value with metrics Process Improvement Value-stream analysis Value-stream mapping Agile Knowledge and Skills Context of Agile Knowledge and Skills vis-à-vis Agile Tools and Techniques Agile Knowledge and Skills Process focused People focused Product focused Project focused Exam Preparation and Course Closure The application process - where are you now? The 'Exam-Focused Journal' - what you still have to do Further preparation - self-study schedule Exam topic review Practice exam Practice exam debrief Course closure