Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. 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. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course 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 14 Points Development Level Develop
A Practical Introduction to Conflict Management for Project Managers
Level 5 & 7 Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 5 CPD Courses | Lifetime Access
***24 Hour Limited Time Flash Sale*** Project Management with Agile Scrum - Endorsed Certificate Admission Gifts FREE PDF & Hard Copy Certificate| PDF Transcripts| FREE Student ID| Assessment| Lifetime Access| Enrolment Letter Unearth the thrilling world of Project Management with our superior bundle: Project Management with Agile Scrum Level 5 & 7 at QLS. This meticulously curated bundle encapsulates two QLS-endorsed courses, Agile Scrum Master and Project Management, fortified by five additional CPD QS accredited courses: Quality Management and Strategic Training - ISO 9001, Strategic Management, Financial Modelling for Decision Making and Business Plan, Team Management, and Diploma in Leadership. Embark on an exploratory journey into the theoretical realms of Agile Scrum and Project Management. Unravel the intricacies of quality management in line with ISO 9001, strategic management, financial modelling, and team management. Immerse yourself in the dynamics of effective leadership, all within the confines of this comprehensive bundle. Recognized certification awaits you at the end of this journey, with two QLS-endorsed courses furnishing you with a hardcopy certificate upon completion. The added value of five CPD QS accredited courses will undeniably enrich your professional growth and recognition. Step into the realm of Project Management and Agile Scrum with our exemplary course bundle. This bundle comprises the following courses: QLS Endorsed Courses: Course 01:Diploma in Agile Scrum Master Training at QLS Level 5 Course 02:Advanced Diploma in Project Management at QLS Level 7 CPD QS Accredited Courses: Course 03: Quality Management and Strategic Training - ISO 9001 Course 04: Strategic Management Course 05: Financial Modelling for Decision Making and Business plan Course 06: Team Management Course 07: Diploma in Leadership Learning Outcomes Upon completion of this Project Management with Agile Scrum Level 5 & 7 at QLS bundle, learners will: Grasp the theoretical foundations of Agile Scrum and Project Management. Comprehend the principles and standards of ISO 9001 for Quality Management. Develop a deep understanding of Strategic Management. Learn about financial modelling for decision making and business planning. Gain insights into effective Team Management. Understand leadership dynamics from a theoretical perspective. Be equipped to apply these theories to real-world scenarios. Obtain certified recognition through QLS-endorsed courses. This intensive bundle dives into the theoretical realms of Agile Scrum and Project Management, supplemented by a broad range of additional subjects that add value to your learning journey. Understanding these topics, learners will develop a deep understanding of ISO 9001 quality management standards, strategic management principles, and financial modelling. These key insights will equip learners with the ability to make informed business decisions and manage teams effectively. The benefits of undertaking these courses are innumerable, with learners acquiring theoretical knowledge in leadership dynamics, quality management, and Agile Scrum methodology. With QLS-endorsed courses providing certified recognition, learners can further enhance their professional credentials, leading to a broader range of opportunities in their chosen field. CPD 300 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Project Management with Agile Scrum Level 5 & 7 at QLS bundle is suitable for: Aspiring Agile Scrum Masters and Project Managers. Professionals looking to enhance their knowledge in quality and strategic management. Individuals interested in learning financial modelling for business planning. Those seeking theoretical knowledge in team management and leadership. Career path Agile Scrum Master, average salary in the UK: £55,000 - £65,000 per annum. Project Manager, average salary in the UK: £37,500 - £47,500 per annum. Quality Manager, average salary in the UK: £35,000 - £45,000 per annum. Strategic Manager, average salary in the UK: £60,000 - £70,000 per annum. Financial Modelling Analyst, average salary in the UK: £45,000 - £55,000 per annum. Certificates Digital certificate Digital certificate - Included Hard copy certificate Hard copy certificate - Included
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From this course, you will learn everything about entrepreneure project management, from market research to prototypes as well as manufacturing and distribution. This course covers the process of filling out patents, conducting competitive and market analysis, selling your invention and setting up the business model. This Course At A Glance Accredited by CPD UK Endorsed by Quality Licence Scheme Know how to validate ideas and conduct market research Learn how to protect your invention and perform prototype testing Know how to do patent filling and enforce it Discover the process of market and competitive analysis Know how to sell your invention Identify the potential buyers and the market Demonstrate the business plan and setup Understand the process of manufacturing and distribution Recognise patent, business and government agency scams Know how to build a website and launch the product Master the art of negotiation with resellers Entrepreneur Project Management Diploma Overview This Entrepreneur Project Management Diploma Online is ideal for entrepreneurs and entrepreneur project managers, as well as for people who want to gain extensive knowledge about entrepreneur project management to run their businesses smoothly. This course will assist you in acquiring the exact methods and techniques you require to effectively manage, lead, and drive your team in order to accomplish your entrepreneurial goals. Additionally, you'll learn how to handle business and patent scams, create websites, and launch products to the market. Upon successful completion of this Entrepreneur Project Management Diploma Online, you will be equipped with essential project management and entrepreneurial knowledge and skills to build your business from scratch. This course is endorsed by the Quality Licence Scheme for its high-quality, non-regulated provision and training programmes. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. This course and/or training programme is not regulated by Ofqual and is not an accredited qualification. Your training provider will be able to advise you on any further recognition, for example, progression routes into further and/or higher education. For further information please visit the Learner FAQs on the Quality Licence Scheme website. Who should take this course? This Entrepreneur Project Management Diploma Online is primarily aimed at: Entrepreneurs Project managers Team leaders Small business owners Entrepreneur project managers Anyone looking to enhance their project management skills However, this course is not restricted to any single profession or field of work. This course can also benefit anyone who wants to learn more about entrepreneur project management in order to launch their own business. Entry Requirements There are no academic entry requirements for this Entrepreneur Project Management Diploma Online, and it is open to students of all academic backgrounds. However, you are required to have a laptop/desktop/tablet or smartphone and a good internet connection. Course Curriculum Phase 1 - Idea Validation Idea Validation Checklist Market Research Prelim Patent Search Prelim Costing Concept Description Product Business Benefits What Problem Does it Solve How to Test Your Idea Industry Data Potential Distribution or Go To Market Contracts and Ndas Phase 2 - Prototype Protecting Your Invention Prototype Development and 3D Cad Design Prototype Testing Should We Do This In China Pros and Cons Product Naming Manufacturing Feasibility What is the Potential Cost to Manufacture What is the Potential Retail Cost Package Design and Costing Phase 3 - Patents What is a Patent Patent Types Patent Search REDO Patent Claims Patent Drawings Patent Filing Patent Pending, What Does That Mean IPR Patent Grant Patent Pitfalls Patent Enforcement I Have a Patent, Am I Protected Can I Go To Market Mock Assessment 1 Assessment Mock 1 Phase 4 - Business Planning Business Planning Introduction Suggested Retail Price Market Analysis Competitive Analysis Product Roadmap Distribution1 Operations Plan Go To Market or Licensing Licensing Licensing Options Phase 5 - Decision Plan Go to Market With Invention Selling Your Invention Identify Potential Buyers Identify Market Phase 6 - Business Set Up Business Plan: The Heartbeat of Your Business How Important is a Business Plan Initial Business Funding Setting Up A Business Bank Account Home Office When Do I Get a Real Office Mock Assessment 2 Assessment Mock 2 Phase 7 - Manufacturing Define Manufacturing Process Mold Design and Production Production Costs Test Production Run Packaging Design_1 Shipping Logistics Local Manufacturers Pros and Cons Phase 8 - Distribution Reseller Landscape Forecasting 3PL Negotiations Live and Die by Distribution Phase 9 - Business Scams and Pitfalls Patent Scams Renewal Based General Business Scams Government Agency Scam Phase 10 - Go To Market Website Build and Launched Manufacturer's Rep Firm Negotiation and Set Up Resellers Negotiation and Set Up Mock Assessment 3 Assessment Mock 3 Final Assessment Assessment - Entrepreneur Project Management Diploma Online Recognised Accreditation CPD Certification Service This course is accredited by continuing professional development (CPD). CPD UK is globally recognised by employers, professional organisations, and academic institutions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. CPD certificates are accepted by thousands of professional bodies and government regulators here in the UK and around the world. Many organisations look for employees with CPD requirements, which means, that by doing this course, you would be a potential candidate in your respective field. Quality Licence Scheme Endorsed The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. It will give you a competitive advantage in your career, making you stand out from all other applicants and employees. Certificate of Achievement Endorsed Certificate from Quality Licence Scheme After successfully passing the MCQ exam you will be eligible to order the Endorsed Certificate by Quality Licence Scheme. The Quality Licence Scheme is a brand of the Skills and Education Group, a leading national awarding organisation for providing high-quality vocational qualifications across a wide range of industries. It will give you a competitive advantage in your career, making you stand out from all other applicants and employees. There is a Quality Licence Scheme endorsement fee to obtain an endorsed certificate which is £65. Certificate of Achievement from Lead Academy After successfully passing the MCQ exam you will be eligible to order your certificate of achievement as proof of your new skill. The certificate of achievement is an official credential that confirms that you successfully finished a course with Lead Academy. Certificate can be obtained in PDF version at a cost of £12, and there is an additional fee to obtain a printed copy certificate which is £35. FAQs Is CPD a recognised qualification in the UK? CPD is globally recognised by employers, professional organisations and academic intuitions, thus a certificate from CPD Certification Service creates value towards your professional goal and achievement. CPD-certified certificates are accepted by thousands of professional bodies and government regulators here in the UK and around the world. Are QLS courses recognised? Although QLS courses are not subject to Ofqual regulation, they must adhere to an extremely high level that is set and regulated independently across the globe. A course that has been approved by the Quality Licence Scheme simply indicates that it has been examined and evaluated in terms of quality and fulfils the predetermined quality standards. When will I receive my certificate? For CPD accredited PDF certificate it will take 24 hours, however for the hardcopy CPD certificate takes 5-7 business days and for the Quality License Scheme certificate it will take 7-9 business days. Can I pay by invoice? Yes, you can pay via Invoice or Purchase Order, please contact us at info@lead-academy.org for invoice payment. Can I pay via instalment? Yes, you can pay via instalments at checkout. How to take online classes from home? Our platform provides easy and comfortable access for all learners; all you need is a stable internet connection and a device such as a laptop, desktop PC, tablet, or mobile phone. The learning site is accessible 24/7, allowing you to take the course at your own pace while relaxing in the privacy of your home or workplace. Does age matter in online learning? No, there is no age limit for online learning. Online learning is accessible to people of all ages and requires no age-specific criteria to pursue a course of interest. As opposed to degrees pursued at university, online courses are designed to break the barriers of age limitation that aim to limit the learner's ability to learn new things, diversify their skills, and expand their horizons. When I will get the login details for my course? After successfully purchasing the course, you will receive an email within 24 hours with the login details of your course. Kindly check your inbox, junk or spam folder, or you can contact our client success team via info@lead-academy.org
Kanban is a popular framework used to implement Agile and DevOps software development. It requires real-time communication of capacity and full transparency of work. A Kanban board is an Agile project management tool designed to help visualize work, limit work-in-progress, and maximize efficiency (or flow).
Agile management is the application of the principles of Agile software development to various management processes, particularly project management. It is particularly beneficial for those in the organization accountable for getting the most out of Scrum, including Scrum masters, managers, and Scrum team members.
AI in Project Management: The Next Generation of Project Decision Making Project managers need to make critical project decisions on a daily basis. They are confronted with increasing complexities, high ambiguity and the need to process an exponentially growing amount of data and information in order to make informed and good decisions. This leads to an increasing risk of project failure - meanwhile, the project management industry is already challenged with ongoing low project success rates, caused by often massive failures of projects. Project Data Analytics and Artificial Intelligence (AI) are expected to fill the gap by providing analytical and unbiased capabilities that go beyond human possibilities, towards a data-driven and fact-based decision-making approach. While there is little doubt that AI as a trending technology will disrupt the project management practice and augment today's project management capabilities, AI cannot be seen as just another new tool to make project management more effective. Rather, AI will act as a complement to human intelligence, requiring a collaborative approach and, accordingly, a significant change in project culture and peoples' mindset. Today's project decisions are usually driven by human intuition, experience, leadership, and often do not follow any rational logic. Project decision-makers will be required to abandon such an approach and shift to a data-driven, decision-making approach. This session will provide an overview of the expected changes from AI-driven project management, the resulting impact on project decision making and changes in project culture, and what actions can be taken by project professionals to match their beliefs and behaviours with the new project culture. Learning goals: Gain insights into how AI for project management will significantly change decision-making in projects Gain an understanding of how to transition to a new AI-powered project culture