Course Information This highly interactive course will provide guidance on why and how to implement a quality system successfully into the research laboratory. By doing so, you will position your innovation for the success it deserves. But leave things as they are and there is a good chance that your science will not realise its full potential should success, and its consequences, come your way. A quality system in your research laboratory is the most effective and efficient way to: Help scientists work more efficiently Ensure discoveries can be defended Protect the value of intellectual property. This course is particularly aimed at those working in early phase research environments which are not constrained by the regulatory requirements of the Good Practice regulations but are producing intellectual property, testing and/or products for the therapeutic market. For organisational reasons, rather than regulatory ones, this is a place where you need to get it right. The programme is delivered by leaders in the field who, quite simply, ‘have done it’. Whether delegates are at senior management level seeking strategic direction, a laboratory head wishing to deliver science that will stand the test of time or a quality professional thrown in at the deep end, this course will provide key insight and practical guidance to underpin future success. Based on risk based systems, tried and tested over many years in the workplace, the programme will help delegates to define, train, implement and monitor the quality of their research, irrespective of field or discipline. Delegates will learn how to help position their organisation for success. Course content: Delegates will be guided thoughtfully through each key component of the process in a stimulating learning environment. The course probes all avenues of the research quality arena, from an initial understanding of the cultural aspects of the scientific discovery environment, to managing quality in outsourced research programmes. Computer systems and e-data security in the research environment will be discussed and pragmatic solutions described to help manage the ballooning cloud of e-data. In addition, the ever blurring boundary between the regulated and non-regulated research environments will be discussed and delegates given perspective on future developments in the field. With this knowledge, delegates will be able to get it ‘right first time’. Is this course for you? The course is designed for all those involved in the research laboratory quality arena and it has been tailored to meet the needs of scientific management, bench scientists and quality professionals alike. Delegates get immediate access to highly experienced tutors who will share their wisdom and insights in an area where few others have been successful. The course is linked with the RQA guidance which builds on years of experience and forms the foundation of the programme. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Sandrine Bongiovanni Associate Director in Research and Quality Compliance, Novartis Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:10 Welcome and Introductions 09:20 History and Overview of the Field Examples of business and regulatory risks and the consequences of low quality in research. A look at the standards and guidelines that exist. 10:00 The Culture, the Politics and the Scientist's Perspective Understanding research environments, the drivers and the challenges. 10:30 Break 10:45 Workshop - Risk Management Thinking about risk management and prioritisation. Looking at the critical factors for the implementations of a successful quality system. 12:15 Workshop - Feedback 12:45 Lunch 13:45 Personnel, Plans, Procedures, Facilities, Equipment, Materials and Reagents Looking at planning the work, defining procedures in a way which promotes robust science without compromising brilliance and ensuring that all these elements are demonstrably fit for their intended purpose. 14:30 Workshop - Assay Validation How much validation is required at what stage? What do we need to validate an assay? 15:00 Workshop - Feedback 15:15 Research, Work Records, Archives and Research Review Data and records which are accurate, attributable, legally attestable and safe to permit reconstruction experiments and studies. Looking at aspects of the work where there is a chance to review, correct or improve the science, the data and the processes. 16:15 Continual Improvement and Quality Systems Reviewing implementation of a quality system, finding opportunities for improvement, understanding culture change. 16:45 Questions and Answers 17:00 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 Develop
Course Information Join us for a comprehensive refresher focusing on crucial Good Laboratory Practice (GLP) requirements, including an emphasis on data integrity, recent developments, and emerging trends gleaned from MHRA inspections. The programme dives into specific domains such as risk assessment, OECD guidance on sponsor influence, and the advisory from OECD on QA. Additionally, delegates can benefit from a dedicated GLP clinic, facilitating discussions on understanding and upholding GLP compliance. Is this course for you? This course is tailored for study directors, principal investigators, test facility management, and QA professionals seeking to refresh their knowledge and responsibilities within the GLP framework. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Registration, Welcome and Introduction 09:20 Development of Good Laboratory Practice A reminder of the history of GLP, its current scope and application, with a synopsis of current UK, European and international standards. 09:50 Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA A reminder of the roles and responsibilities with regard to the GLP management and oversight of the Test Facility and the management and control of the study, as defined by GLP. 10:30 Break 10:45 Workshop 1 Workshop 1 Roles and responsibilities 11:15 Influence of Sponsors The published OECD Position Paper No. 21 regarding Possible Influence of Sponsors on conclusions of GLP Studies is reviewed and discussed. 11:45 Data Integrity The fundamentals of data integrity according to the OECD Guidance No. 22 on Data Integrity is discussed along with the responsibilities of Study Director, Test Facility Management, and study staff in ensuring the integrity of the GLP study data. 12:30 Lunch 13:15 Quality Assurance and GLP OECD Advisory No. 23 (Revision of OECD No.4)- A walk through of the changes to the OECD Guidance on the role and activities of Quality Assurance 13:45 Quality Improvement Tools and GLP The tools that might be considered for GLP and their role and operation when used in Test Facilities- OECD Position Paper No.24 published July 2022 14:15 Workshop 2 Workshop 2 Change control 14:30 Risk Assessment How should we assess risk and how can we use the process to assist in evaluation audit findings? 15:00 Break 15:15 Current hot topics in GLP Explore the current issues in Industry and trends /types of Regulatory inspection findings 15:50 GLP Clinic An opportunity to discuss any other issues regarding understanding and maintaining GLP Compliance. 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
ITIL® 4 Specialist: High-Velocity IT: On-Demand This course is based on the ITIL® 4 Specialist: High-Velocity IT exam specifications from AXELOS. With the help of ITIL® 4 concepts and terminology, exercises, and examples included in the course, candidates acquire the relevant knowledge required to pass the certification exam. What You Will Learn At the end of this course, participants will be able to: Understand concepts regarding the high-velocity nature of the digital enterprise, including the demand it places on IT. Understand the digital product lifecycle in terms of the ITIL operating model. Understand the importance of the ITIL guiding principles and other fundamental concepts for delivering high-velocity IT. Know how to contribute to achieving value with digital products. Course Introduction Introduction to High-Velocity IT High-Velocity IT Approaches High-Velocity IT Operating Models Introduction ITIL Building Blocks for High-Velocity IT Supporting Models and Concepts for Purpose Supporting Models and Concepts for People Supporting Models and Concepts for Progress High-Velocity IT Objectives and Techniques Techniques for Valuable Investments Techniques for Fast Developments Techniques for Resilient Operations Techniques for Co-created Value Techniques for Assured Conformance
ITIL® 4 Specialist: Drive Stakeholder Value: On-Demand The ITIL® 4 Specialist: Drive Stakeholder Value module is part of the Managing Professional stream for ITIL 4. Candidates need to pass the related certification exam for working towards the Managing Professional (MP) designation. This course is based on the ITIL® 4 Specialist: Drive Stakeholder Value exam specifications from AXELOS. With the help of ITIL® 4 concepts and terminology, exercises, and examples included in the course, candidates acquire the relevant knowledge required to pass the certification exam. What You Will Learn The learning objectives of the course are based on the following learning outcomes of the ITIL® 4 Specialist: Drive Stakeholder Value exam specification: Understand how customer journeys are designed Know how to target markets and stakeholders Know how to foster stakeholder relationships Know how to shape demand and define service offerings Know how to align expectations and agree on details of services Know how to onboard and offboard customers and users Know how to act together to ensure continual value co-creation (service consumption / provisioning) Know how to realize and validate service value Customer Journey Purpose of the Module Purpose of Mastering the Customer Journey Touchpoints and Service Interactions Module Topics Mapping the Customer Journey Designing the Customer Journey Measuring and Improving the Customer Journey Customer Journey Step 1: Explore Purpose of the Module Purpose of the Explore Step Module Topics Understanding Service Consumers Understanding Service Providers Understanding and Targeting Markets Customer Journey Step 2: Engage Purpose of the Module Purpose of the Engage Step Aspects of Service Value Module Topics Service Relationship Types Building Service Relationships Building and Sustaining Trust and Relationships Analyzing Customer Needs Managing Suppliers and Partners Customer Journey Step 3: Offer Purpose of the Module Purpose of Shaping Demand and Service Offerings Module Topics Managing Demand and Opportunities Specifying and Managing Customer Requirements Designing Service Offerings and User Experience Selling and Obtaining Service Offerings Customer Journey Step 4: Agree Purpose of the Module Purpose of Aligning Expectations and Agreeing on Services Module Topics Agreeing on and Planning Value Co-Creation Negotiating and Agreeing on a Service Customer Journey Step 5: Onboard Purpose of the Module Purpose of Onboarding and Offboarding ITIL® Management Practices Module Topics Planning Onboarding Fostering Relationships with Users Providing User Engagement and Delivery Channels Enabling Users for Service Elevating Mutual Capabilities Offboarding Customer Journey Step 6: Co-create Purpose of the Module Purpose of Service Provision and Consumption Module Topics Service Mindset Ongoing Service Interactions Nurturing User Communities Customer Journey Step 7: Realize Purpose of the Module Measuring Service Value Purpose of Value Capturing and Customer Journey Improvement Realizing Service Value in Different Settings Module Topics Tracking Value Realization Assessing and Reporting Value Realization Evaluating Value Realization and Improving Customer Journeys Realizing Value for the Service Provider
Assuring Quality Through Acceptance Testing - Making Sure that the Business Problem is Solved: On-Demand It is the business analyst's job to define the business problem to be solved by IT. It is also the business analyst's responsibility to confirm that the resulting solution developed by IT does, in fact, solve the defined problem. This is done first through testing, especially acceptance testing, and then through monitoring of the installed solution in the user community. The business analyst is not only concerned with the testing itself, but also with the management and monitoring of the users doing the acceptance testing, and recording, analyzing, and evaluating the results. What You Will Learn Upon completion of this course, participants will be able to: Create a set of acceptance test cases Manage and monitor an acceptance test stage where users perform the testing Work with the development team in the systems testing stage Assess the solution once it is in the business environment Foundation Concepts The role of the business analyst An introduction to the BABOK® Guide BA roles and relationships through the project life cycle Introduction to assuring software quality through acceptance testing The Scope of IT Testing Overview of testing stages The testing process Testing documentation Pre-Acceptance Testing The BA's role in testing Early development testing stages (unit and integration) Late development testing stage (system) The Acceptance Test Stage - Part I (Planning, Design, and Development) Overview of user acceptance testing Acceptance test planning Designing user acceptance tests Developing individual user acceptance test cases Building effective user acceptance test scenarios The Acceptance Test Stage - Part II (Execution and Reporting) Operating guidelines Execution Reporting Post-Acceptance Testing Overview Project implementation Project transition (project closure) Production through retirement Testing Commercial Off-the-Shelf (COTS) Software Overview Selecting the software Implementing the software Summary What did we learn and how can we implement this in our work environments?
Work Breakdown Structures It's amazing how often project managers begin the project planning process by making an outlined list of every task they believe will be required to complete a project and then proclaim they have created the work breakdown structure (WBS) for the project. The result is a list of hundreds, or even thousands of tasks, many of them having durations of a few days or a few hours. Essentially, what they have done is create a 'to do' list, which they then use as a 'checklist' to measure progress. This approach leads to, and even encourages, micromanagement of the resources working on the project without consideration of more critical aspects of project management such as: requirements management, risk management, procurement management, estimating, scheduling, executing, and controlling. Further, it makes it impossible to see the big picture, at levels of detail, in keeping with the needs of sponsors, clients, project and functional managers, team leaders, and project performers. Join us for this exciting program and learn how to use the WBS to make better-informed business decisions. What You Will Learn You will learn how to: Describe the need for a project WBS Describe the WBS role in the project Gain practical experience in the development, decomposition, and use of the WBS Determine the appropriate level of detail in the WBS. Explain how the WBS integrates with project requirements, risk, procurement, estimating, scheduling, and overall project execution. Provide the basic tools to enhance efficient re-use of key information in your future projects Foundation Concepts Key definitions History of the WBS Importance of the WBS Overall structure Terminology Other breakdown structures WBS tools WBS & Scope Project scope management processes Specification of the project objectives WBS design based on project deliverable WBS decomposition process and 'The 100% rule' Work Packages and Control Accounts WBS & Risk Risk management planning and WBS Risk identification to enhance the WBS Risk analysis and the WBS Risk responses and updating the WBS Implementing risk response and Monitoring risks and the WBS WBS & Estimating Use of WBS in the estimating process Components and work packages Sizing and algorithmic estimates WBS & Scheduling Component Scheduling - High-Level Milestones WBS activity decomposition WBS elements dependencies Work Package Level Schedules Responsibility assignment matrix WBS & Execution and Control Earned Value Management and tracking of work performance Progress reports, forecasts, and corrective and preventive actions used to manage work performance Necessary information to close out a project
Agile Sprint Planning: On-Demand The goal of the course is to provide you and your team with the ability to develop effective and realistic Sprint plans. Without effective Sprint Plans, iterations are set up for failure. But Sprint Planning cannot be improved on its own, in isolation. The Scrum processes are highly intertwined and influence each other. The surrounding artifacts, events, and roles must be examined closely, and enhanced, in order to improve Sprint Planning. This course will remind you of the theory to reinforce the principles, but will concentrate on next-level skills, so that you and the team are able to create realistic and usable Sprint Plans. This course is not introductory. You are already aware of the Scrum framework and have been implementing Scrum on your projects. Now is the time to improve efficiency and effectiveness, to facilitate successful Agile projects. What you will Learn You'll learn how to: Identify and correlate the key symptoms and root causes of ineffective sprint plans Improve key Product Backlog elements Evaluate Agile roles in sprint planning Appraise key product practices Enhance project transparency The Product Backlog User stories Acceptance Criteria Backlog Refinement Supporting Roles Product Owner (the Backlog) Development Team Stakeholders and SMEs Supporting Product Practices Roadmaps and release plans and story maps Definition of Done Technical Debt Transparency Daily Scrums Information radiators Retrospectives Sprint Planning Capacity and Velocity Sprint Planning Meetings The Sprint Backlog Summary What did we learn, and how can we implement this in our work environments?
Management of Portfolios (MoP®) Foundations: On-Demand The purpose of the Foundation certification is to confirm that you have sufficient knowledge and understanding to work as an informed member of a Portfolio Office or in a range of portfolio management roles. In this MoP Foundation course, participants will acquire the sufficient knowledge and understanding of the principles, cycles, practices, techniques, roles, responsibilities, documents, and organizational context within which portfolio management operates. MoP helps organizations ensure if the investments are done in the right change initiatives and implementing them correctly. This is achieved by: Prioritizing the programs and projects in terms of their contribution to the organization's strategic objectives and overall level of risk Managing the programs and projects consistently to ensure efficient and effective delivery Maximizing the benefit by providing the greatest return from the investment made What You Will Learn Individuals certified at the MoP Foundation level will be able to: Define the scope and objectives of portfolio management and how it differs from program and project management List the benefits of applying portfolio management Explain the context it operates in List the principles upon which successful portfolio management is based on List the different approaches to implement MoP List the factors required to maintain the progress and assess the success of portfolio management State the purpose and key content of the major portfolio documents Define the scope of key portfolio management roles Introduction: MoP Scenario Background of the MethodologyThe MoP Principles Senior Management Commitment Governance Alignment Strategy Alignment Portfolio Office Energized Change Culture The MoP Definition CycleRoles and ResponsibilitiesThe MoP Delivery Cycle Management control Benefits management Financial management Risk management Stakeholder engagement Organizational governance Resource management The MoP Framework
Management of Portfolios (MoP®) Foundation: On-Demand In this MoP® Foundation course, participants will acquire the sufficient knowledge and understanding of the principles, cycles, practices, techniques, roles, responsibilities, documents, and organizational context within which portfolio management operates. MoP helps organizations ensure if the investments are done in the right change initiatives and implementing them correctly. This is achieved by: Prioritizing the programs and projects in terms of their contribution to the organization's strategic objectives and overall level of risk Managing the programs and projects consistently to ensure efficient and effective delivery Maximizing the benefit by providing the greatest return from the investment made What You Will Learn Individuals certified at the MoP Foundation level will be able to: Define the scope and objectives of portfolio management and how it differs from program and project management List the benefits of applying portfolio management Explain the context it operates in List the principles upon which successful portfolio management is based on List the different approaches to implement MoP List the factors required to maintain the progress and assess the success of portfolio management State the purpose and key content of the major portfolio documents Define the scope of key portfolio management roles Introduction: MoP Scenario Background of the Methodology The MoP Principles Senior Management Commitment Governance Alignment Strategy Alignment Portfolio Office Energized Change Culture The MoP Definition Cycle Roles and Responsibilities The MoP Delivery Cycle Management control Benefits management Financial management Risk management Stakeholder engagement Organizational governance Resource management The MoP Framework Recap
Building High Performance Project Teams: On-Demand This course pulls together the most current and popular theories and writings on this complex topic and presents this amalgamated view in a highly interactive workshop and activity-based approach. Students will understand and have the skills required to build and participate in high-performance project teams and will possess the insight to proactively affect change within their respective organizations by guiding the existing culture to one that promotes high performance. What You Will Learn At the end of this program, you will be able to: Define a team and describe the optimum team size for effective performance Describe characteristics and guiding behaviors of high-performance teams Describe the major elements of each development stage in two distinct models Recognize cultural barriers in achieving high performance List the attributes of a high-performing corporate culture Assess your own corporate culture Discuss corporate leadership as a factor in building high-performance project teams Describe the three A's of selecting team members State three leadership responsibilities Describe leadership responsibilities, styles, and roles List and describe the eight components of the team charter model for building high-performance teams Foundation Concepts The Nature of Teams Characteristics of High-Performance Teams Understanding Team Development Stages of Team Development - Model 1 Stages of Team Development - Model 2 Designing a High-Performance Culture Corporate Cultures Corporate Leadership Establishing the Attributes of High Performance Choosing the Right People Team Effectiveness Team Leadership The Team Charter Model