3 Courses in Manchester

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

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

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

Venture into the dynamic realm of operations management with our comprehensive course, crafted to mold you into a master of operational excellence. This educational odyssey starts with an introduction to the fundamentals of operations management, laying the groundwork for a deep dive into the intricacies of efficient and effective business operations. As you navigate through the modules, you will encounter the strategic world of project management, a cornerstone in driving successful business initiatives. Imagine orchestrating the symphony of business development, process, and supply chain management, harmonizing each aspect to create a seamless operational flow. This course meticulously guides you through advanced concepts like planning and forecasting, procurement, and manufacturing operations, each module building upon the last to create a robust understanding of the field. Delve into the critical areas of quality management, risk mitigation, and performance optimization. Towards the latter modules, the course enriches your managerial skill set, focusing on talent management, communication, negotiation, and conflict resolution, essential for navigating the complexities of the contemporary business landscape. Learning Outcomes Attain a solid foundation in operations management principles. Develop strategic project management skills. Master the essentials of supply chain and process management. Learn effective techniques in planning, forecasting, and procurement. Enhance skills in quality, risk, and performance management. Why choose this Operations Management course? Unlimited access to the course for a lifetime. Opportunity to earn a certificate accredited by the CPD Quality Standards and CIQ after completing this course. Structured lesson planning in line with industry standards. Immerse yourself in innovative and captivating course materials and activities. Assessments designed to evaluate advanced cognitive abilities and skill proficiency. Flexibility to complete the Course at your own pace, on your own schedule. Receive full tutor support throughout the week, from Monday to Friday, to enhance your learning experience. Unlock career resources for CV improvement, interview readiness, and job success. Who is this Operations Management course for? Aspiring operations managers seeking comprehensive knowledge. Business professionals aiming to refine operational strategies. Individuals interested in a career in supply chain management. Managers looking to enhance their project management skills. Entrepreneurs seeking to optimize their business operations. Career path Operations Manager - £30,000 to £55,000 Project Manager - £33,000 to £50,000 Supply Chain Coordinator - £25,000 to £40,000 Quality Assurance Manager - £30,000 to £45,000 Risk Management Specialist - £35,000 to £55,000 Business Development Executive - £28,000 to £50,000 Prerequisites This Operations Management Diploma does not require you to have any prior qualifications or experience. You can just enrol and start learning.This Operations Management Diploma was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Certification After studying the course materials, there will be a written assignment test which you can take at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £4.99 Original Hard Copy certificates need to be ordered at an additional cost of £8. Course Curriculum Module 01: Introduction to Operations Management Introduction to Operations Management 00:23:00 Module 02: Project Management Project Management 00:22:00 Module 03: Business Development and Succession Planning Business Development and Succession Planning 00:27:00 Module 04: Process Management Process Management 00:26:00 Module 05: Supply Chain Management Supply Chain Management 00:23:00 Module 06: Planning & Forecasting Operations Planning & Forecasting Operations 00:23:00 Module 07: Procurement & Purchasing Management Procurement & Purchasing Management 00:23:00 Module 08: Manufacturing & Delivery Operations Manufacturing & Delivery Operations 00:19:00 Module 09: Quality Management Quality Management 00:23:00 Module 10: Managing Risk and Recovery Managing Risk and Recovery 00:29:00 Module 11: Performance Management Performance Management 00:21:00 Module 12: Talent Management Talent Management 00:20:00 Module 13: Communication Skills Communication Skills 00:26:00 Module 14: Negotiation Techniques Negotiation Techniques 00:19:00 Module 15: Conflict Management Conflict Management 00:17:00 Module 16: Stress Management Stress Management 00:19:00 Module 17: Time Management Time Management 00:40:00 Module 18: Business Environment Business Environment 00:19:00 Module 19: Business Writing Skills Business Writing Skills 00:39:00