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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

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

ITIL® 4 Strategist: Direct, Plan and Improve: On-Demand The ITIL® 4 Strategist: Direct, Plan, and Improve course is based on the ITIL® 4 Strategist Direct, Plan, and Improve candidate syllabus from AXELOS. This course is based on the ITIL® 4 Strategist: Direct, Plan and Improve 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. This course provides the practical skills necessary to create a 'learning and improving' IT organization, with a strong and effective strategic direction. It was designed to provide practitioners with a practical and strategic method for planning and delivering continual improvement with necessary agility. It covers both practical and strategic elements, making it the universal module that is a key component to both ITIL® 4 Managing Professional and ITIL® 4 Strategic Leader streams. What You Will Learn At the end of this course, participants will be able to: Understand the key concepts of direction, planning, improvement Understand the scope of what is to be directed and/or planned and know how to use key principles and methods of direction and planning in that context Understand the role of GRC and know how to integrate the principles and methods into the service value system Understand and know how to use the key principles and methods of continual improvement for all types of improvements Understand and know how to use the key principles and methods of Communication and Organizational Change Management to direction, planning and improvement Understand and know how to use the key principles and methods of measurement and reporting in direction, planning, and improvement Understand and know how to direct, plan, and improve value streams and practices Course Introduction Let's Get to Know Each Other Course Overview ITIL® 4 Certification Scheme Course Learning Objectives Course Components Course Agenda Exercises Case Study: Axle Car Hire Case Study: HandyPerson on Demand Exam Details Core Concepts of DPI Key Terms Covered in the Module Module Learning Objectives Basics of Direction Basics of Planning Basics of Improvement Other Core Elements DPI through Service Value Chain and Guiding Principles Key Terms Covered in the Module Module Learning Objectives DPI of the SVS DPI of Guiding Principles Role of Direction in Strategy Management Key Terms Covered in the Module Introducing Strategy Management Developing Effective Strategies Implementation of Strategies Key Terms Covered in the Module Module Learning Objectives Managing Risks Making Decisions through Portfolio Management Directing via Governance, Risk, and Compliance (GRC) Introduction to Assessment and Planning Key Terms Covered in the Module Module Learning Objectives Core Concepts of Assessment Conducting Effective Assessments Core Concepts of Planning Assessment and Planning through VSM Key Terms Covered in the Module Module Learning Objectives Introducing VSM Developing Value Stream Maps Knowing More About VSM Measurement, Reporting, and Continual Improvement Key Terms Covered in the Module Module Learning Objectives Measurement and Reporting Alignment of Measurements and Metrics Success Factors and Key Performance Indicators Continual Improvement Measurements and Continual Improvement through Dimensions and SVS Key Terms Covered in the Module Module Learning Objectives Measurements for the Four Dimensions Continual Improvement of the Service Value Chain and Practices OCM Principles and Methods Key Terms Covered in the Module Module Learning Objectives Basics of OCM OCM throughout DPI and Service Value Chain Resistance and Reinforcement Communication Principles and Methods Key Terms Covered in the Module Module Learning Objectives Basics of Effective Communication Communication with Stakeholders SVS Development Using Four Dimensions Key Terms Covered in the Module Module Learning Objectives Organizations and People in the SVS Partners and Suppliers in the SVS Value Streams and Processes in the SVS Information and Technology in the SVS

Conflict Resolution Skills (On-Demand) Many organizations have assumed that workplace conflict is always destructive. So, they have often believed that conflict is best dealt with by managers or even via policies and procedures. After all, conflict creates workplace stress and leads to many performance problems, generating very real organizational costs! However, savvy organizations have embraced the fact that when conflict is understood and harnessed, it can be leveraged to add value to teams and even enhance performance. With the right knowledge, skills, training, and practice, conflict can be productive and make organizations better! In this highly interactive course, learners will discover the connection between individual conflict response and team-empowering conflict resolution skills. Participants will explore conflict's visceral dynamics and the nuanced behaviors we individually engage in to communicate and respond to conflict. Learners will apply techniques for transforming unproductive conflict responses into productive ones. Additionally, learners will use a systematic method that prepares them to objectively dissect real-world conflict, while practicing many strategies for resolving it. They will also develop proactive conflict approach plans, which they can transfer back to their own workplaces. At the end of this program, you will be able to: Recognize the organizational costs of conflict Explain our physical and mental responses to conflict Communicate proactively and effectively with different types of people during conflict Replace unproductive conflict responses with productive ones Use the Conflict Resolution Diagram (CRD) process and conflict resolution approaches Relate team stages of development to shifts in conflict Develop a proactive conflict approach for your organization Create a conflict resolution plan for a real-world scenario Getting Started Introductions and social agreements Course goal and objectives Opening activities Conflict Facilitation Readiness Conflict responses and perceptions Conflict basics Conflict and organizations Dynamics of conflict Conflict Styles and Communication A look at the color energies model Conflict through the color energies and DiSC® lens Communication with opposite color energies Individual Response to Conflict The anatomy of conflict Recognizing unproductive conflict responses 4 steps to productive conflict Choosing productive conflict responses Team Performance and Conflict High-performing team relationships Conflict and project team performance Conflict Resolution Diagram (CRD) and process Conflict Facilitation - Preparation Recognizing context and stakeholder needs Using team conflict resolution approaches Preparing for Crucial Conversations® Conflict Facilitation - Clarity Exposing assumptions and biases Defining the conflict and using the CRD Conflict Facilitation - Action Proactive conflict management Conflict facilitation practice Summary and Next Steps Review Personal action plans

Effecting Business Process Improvement - The Proactive Business Analyst: On-Demand Business analysts facilitate the solution of business problems. The solutions are put into practice as changes to the way people perform in their organizations and the tools they use. The business analyst is a change agent who must understand the basic principles of quality management. This course covers the key role that business analysts play in organizational change management. What You Will Learn You will learn how to: Define and document a business process Work with various business modeling techniques Perform an enterprise analysis in preparation for determining requirements Analyze business processes to discern problems Foundation Concepts Overview of business analysis and process improvement Defining the business process Introducing the proactive business analyst Focusing on business process improvement for business analysts Launching a Successful Business Process Improvement Project Overview of the launch phase Understanding and creating organizational strategy Selecting the target process Aligning the business process improvement project's goals and objectives with organizational strategy Defining the Current Process Overview of current process phase Documenting the business process Business modeling options: work-flow models Business modeling options: Unified Modeling Language (UML) model adaptations for business processes Analyzing the Current Process Process analysis overview Evaluation: establishing the control group Opportunity techniques: multi-discipline problem-solving Opportunity techniques: matrices Building and Sustaining a Recommended Process Overview of the recommended process and beyond Impact analysis Recommended process Transition to the business case Return to proactive state

Writing and Managing Requirements Documents - Creating the Acceptable, Approvable Requirements Document: On-Demand This course will enhance the skill set needed for writing and managing the complex readership that business analysts interact with on a day-to-day basis. What You Will Learn Upon Completion, participants will be able to: Write an understood requirements document that is approvable and acceptable Validate a requirements document Manage the changes to requirements documents through the SDLC Foundation Concepts The role of the business analyst An introduction to the BABOK® Guide The business analyst and the product/project life cycle The requirements documentation process Planning for Effective Requirements Documentation Overview of requirements planning Planning for validation Planning for verification: well-formed criteria Planning for verification: understood and usable criteria Writing Effective Requirements Documents Overview of writing requirements documents Using a standard structure / template Applying formatting techniques Meeting the challenge of writing non-functional requirements Baselining Requirements Documents Overview of the requirements baseline process Validation Verification Approval Managing Requirements Change through the Product Life Cycle Overview of requirements change management Establishing a formal change management process Tracing requirements through design and development (build, test, and implementation) Following through to post-implementation (transition and early production) Summary What did we learn, and how can we implement this in our work environments?

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

Managing Multiple Projects: On-Demand Succeeding in today's competitive marketplace often requires cycle time reduction - reducing the duration of projects and getting results faster. This workshop will address managing multiple projects within the context of program or product management. Are your projects taking longer and longer to complete? Are results less than optimal because of time pressures on resources? Would you like to increase project 'throughout'? Succeeding in today's competitive marketplace often requires cycle time reduction - reducing the duration of projects and getting results faster. This workshop will address managing multiple projects within the context of program or product management. Planning and managing individual projects is challenging. When introducing the real-life limitation of resources and other outside influences into the multi-project environment, those challenges are magnified, and new challenges are introduced. This interactive workshop will position you for immediate action. The goal of this course is to equip you with the necessary knowledge, skills, and techniques so that you can effectively and productively manage multiple projects. What you Will Learn You'll learn how to: Manage stakeholder relationships and expectations Prioritize and sequence multiple projects Manage time and stress within a multiple project environment Effectively manage logical dependencies among projects Optimize the use of resources across multiple projects using concepts from Critical Chain methods Manage risk and communications in a multiple project environment Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Portfolio, program, and project management principles The multiple project environment The MMP Process Model Developing the Multiple Project List Multiple project portfolio management Project selection Project categories and types The multiple project list Multiple Project Logical Dependencies Project dependencies Types of multiple project portfolios Categories of logical dependencies across multiple projects Project priorities in the multiple project schedule Multiple Project Resource Management Multiple project resources and resource management concepts Multiple project resource loading Resource pool and resource database Multiple project resource issues and outsourcing Critical chain resource management, including drum resources and multi-tasking Managing Risk Across Multiple Projects Multiple project risk management process Identifying, assessing, and responding to multiple project risks Critical chain and multiple project risks Risk interrelationship management methods Creating and Executing the Multiple Project Plan The multiple project plan Multiple project scheduling Multiple project budgeting Executing and maintaining the multiple project plan Controlling in the multiple project environment Tools in multiple project management Multiple Project Communications Effective communication in the multiple project environment Common communication barriers Multiple project communications plan Resolving multiple project conflicts Summary and Next Steps What did we learn, and how can we implement this in our work environments?

Project Leadership Skills - Français (On-Demand) Pour être efficace au sein d'une organisation, les responsables de projet doivent avoir une grande variété de compétences et d'aptitudes. Parmi celles-ci figurent: la création et l'exécution d'une vision; motiver les autres; influencer sans autorité; la mise en réseau; communiquer haut, bas et latéralement; la négociation; gestion des parties prenantes; et gérer les conflits. Cet atelier vise à développer les compétences générales essentielles à la direction d'une équipe et à la création d'un changement d'entreprise durable. Les participants auront un aperçu des sciences sociales et de la science du cerveau pour motiver et responsabiliser les autres. Ils apprendront et expérimenteront diverses stratégies et tactiques d'influence. Les participants découvriront également leurs préférences personnelles en matière de communication, leurs points forts et leurs angles morts et apprendront comment communiquer au mieux avec d'autres personnes qu'ils jugent «difficiles». Ils apprendront mieux à gérer le côté humain du changement et à apprendre des stratégies pour gérer chaque étape. Dans le processus. Les activités pratiques de négociation et de gestion des conflits renforcent l'apprentissage théorique, l'enracinant dans la vie réelle et le rendant exploitable. What you will Learn At the end of this program, you will be able to: Explain the importance of a vision in driving motivation and engagement Apply a scientific approach to better motivate those around you Strategically maximize your personal and positional power for better project results Determine influence and network development strategies necessary for personal development Know how to respond to communication challenges related to different personality styles Make the link between the expectations of stakeholders and the success criteria of a project Assess key stakeholders across different dimensions of complexity Apply the four rules of principled negotiation to real-life conflict situations Recognize key aspects of a physiological response to conflict Make the right choice of tools and techniques to "demine" an emotional situation Maximize different strategies and tactics to manage ambiguity at work Manage vision and purpose / Motivate others Communication and alignment with the vision Link the present to the future The Importance of Purpose The art and science of motivation Network development and influence Positive policy and project success Types of power in an organization power and influence Network Development Best Practices Communication The medium and the message Personality and communication styles Communication challenges Stakeholder management / Negotiation Identification of stakeholders Stakeholder analysis The basics of negotiation reasoned negotiation Manage the conflict Conflict dynamics The Anatomy of Conflict Conflict management approaches and tools Dealing with Ambiguity

Strategic Thinking: On-Demand The goal of this course is to provide you with the building blocks and the motivation to develop the critical skill of strategic thinking. The participants will consider a four-part model that distinguishes strategic thinking from strategic planning and managing. With that understanding, you will investigate the critical components of strategic thinking and how to apply it effectively. What you Will Learn Define strategic thinking and distinguish it from strategic planning and management Explain a high-level approach to gaining strategic thinking skills Integrate other interpersonal skills, such as self-awareness, systems thinking, leadership, constructive conflict, and collaboration, into the fabric of strategic thinking skills Select appropriate techniques to apply strategic thinking in specific situations Recognize and emulate effective strategic thinking behaviors Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Interactive event: Define Strategic Thinking (ST) Interactive event: Discuss relationship of ST with Strategic Planning, Management and Decision Making Strategic Level Framework - Tying it all together Strategic thinking attributes Strategic Thinking Critical Success Factors Strategic Thinking Critical Success Factors - 5-part model Strategic Thinking and the Organization Critical Success Factors Model applied to an organization Tools Introduction (5): Environmental, 5 Forces, SWOT, Value Proposition, Integral Theory of Worldview Video: Fog of War Strategic Thinking and the Individual Critical Success Factors Model applied to an individual Tools Introduction (5): Thinking Styles, Six Thinking Hats, Reverse Thinking, Systems Thinking, Integral Theory of Worldview Strategic Thinking at the Interpersonal and Team Levels Emotional Intelligence - Self Awareness and Working With Others Team Leadership and Trust Constructive Conflict as the Gateway to Collaboration Interactive event: Testing the Models - Challenge Perspective; What's Missing Applying the critical skill of Strategic Thinking Worldview: Team versus client Trusted Advisor Interactive event: Doing what is asked (Case study, wherein participants review the default case scenario prepared for this workshop and add specific details to make the scenario more relevant to their experiences / needs. Teams develop an action plan for applying ST concepts and techniques they have learned here to the situation, then compare and contrast results.)