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
AgileSHIFT® AgileSHIFT® is the change your organization needs: the business landscape is changing and transformation is necessary. But it is also hard. This program is aimed to drive transformational change throughout an organization. This new enterprise agility guidance empowers individuals to use a lightweight tailorable framework to understand, engage with, and champion change by embracing agile and lean ways of working. Taking a holistic view of an organization, AgileSHIFT® will create and support the champions of change your business needs in order to thrive in an increasingly competitive and disruptive workplace. What You Will Learn At the end of this program you will be able to: Identify why organizations need to create a culture of enterprise agility in response to a changing context Recognize how to think and work differently to enable change Explore agile and lean thinking concepts and how they relate to running and changing your organization Utilize key concepts of the AgileSHIFT® framework Describe the AgileSHIFT® delivery approach Getting Started A changing context Enterprise agility The Purpose of AgileSHIFT® The AgileSHIFT® Framework AgileSHIFT® principles AgileSHIFT® practices AgileSHIFT® roles AgileSHIFT® workflow Benefits of AXELOS.com Summary and Next Steps
Vendor Relationship Management: On-Demand A successful project is dependent upon the contribution of vendors. After the selection and procurement of a vendor has occurred, the project manager assumes the responsibility for managing the vendor relationship. Managing vendor performance and the vendor relationship can make or break a project. Through case scenarios and an interactive workshop approach, this program deals with the challenging task of delivering a successful project involving significant vendor contributions. What You Will Learn You'll learn how to: Determine stakeholder interests, impact on the project, and requirements Explain the process of planning for and preparing a contract Describe best practices for managing the quality of products and services Identify key techniques for managing vendor relationships Take proactive steps to ensure good working relationships with third parties Emphasize quality in the work performed by external resources Engage in requirements gathering and management Understand Agreements, Statements of Work, Letters of Intent and Contracts Develop an effective contract change control process Discuss the steps for closing a contract Getting Started Introductions Course structure Course goals and objectives Stakeholder Relationships Identifying stakeholders Planning stakeholder management Managing stakeholder engagement Controlling stakeholder engagement Event: Worksheet: What Are Your Issues with Stakeholders? Understanding the Procurement Process Planning procurement management Conducting procurements Controlling procurements Closing procurements Event - Discuss the project's outsourced scope and qualities of an ideal vendor and customize a set of criteria for this project including descriptions and weightings Requirements Gathering and Management Requirements gathering Requirements management Managing relationships Contract change control Change management Event - Small Group Activity: Identifying Gaps in the Requirements Process Agreements, Statements of Work, Letters of Intent and Contracts Contract controls Agreements Contracts Negotiations Closing the contract Contract termination Procurement Audits and Lessons Learned Event - Class Activity: Win-Win Negotiating Summary and Next Steps What did we learn, and how can we implement this in our work environments?
Portfolio Management Skills: On-Demand Project Management Institute (PMI)® Charter Global Registered Education Provider (R.E.P.) International Institute for Learning (IIL) has been reviewed and approved as a provider of project management training by PMI®. Become a strong, effective change advocate for meaningful portfolio management. This course is designed to equip and enable you to effectively and efficiently support the Executive Leadership and Operational Management to plan, implement, manage, and evolve portfolio management in your organization. It focuses on helping you become a strong and effective change advocate for meaningful portfolio management that delivers objective measurements of benefit contribution towards the strategic objectives to lead, manage, and continuously improve portfolio management governance, processes, and frameworks with and through the direction of a portfolio practice, principles, and delivery boards. What you Will Learn At the end of this program, you will be able to: Articulate the benefits of portfolio management Link the initiatives in an organization with its strategic objectives Participate in the introduction of portfolio management in an organization Create or improve the portfolio governance structure Lead the inventory of ongoing and new initiatives Assist the executives in the prioritization of initiatives through the use of Multi-criteria Analysis and other selection tools Support the executives in balancing the portfolio based on the optimal use of resources and priorities Create a portfolio delivery plan Define thresholds and variance reporting criteria Assist the executives and the financial team in the definition of Stage Gate Funding Lead the Stage Gate reviews Analyze the benefits that are being realized by the initiatives Foundation Concepts Definitions Benefits of Portfolio Management Objectives of Portfolio Management Portfolio Life Cycles Governing the Portfolio Portfolio Governance structure Roles and responsibilities Initial activities when starting portfolio management Prioritizing Initiatives Prioritize purpose Multi-Criteria Analysis Analytical Hierarchy Process (AHP) Strategic alignment Balancing the Portfolio Allocating resources and budgets Communicating decisions of initiatives status Planning the Portfolio Planning review cycles Using Stage Gate Funding Setting thresholds and variance reporting Tool examples Managing the Portfolio Delivery Project and Program Life Cycles Stage Gate Reviews Loop back to Prioritize, Balance and Plan Interaction with the Portfolio Delivery Board Project, Program and Functional Managers' roles and responsibilities
Work Breakdown Structures - Français: On-Demand It's amazing how often project managers start the project planning process by making a list of all the tasks they think will be needed to complete a project, then proclaiming that they've created the breakdown structure. (WBS) for the project.The result is a list of hundreds or even thousands of tasks, many of which have a duration of a few days or a few hours. Essentially what they did was create a 'to do' list, which they then use as a 'checklist' to measure progress.This approach leads to, and even encourages, the micromanagement of resources working on the project without considering the more critical aspects of project management such as: requirements management, risk management, procurement management, estimating , planning, execution and control.Moreover, it is impossible to see the big picture, at detailed levels, in line with the needs of sponsors, customers, project and functional managers, team leaders and project implementers. Join us for this exciting program and learn how to use the WBS to make more informed business decisions. What You Will Learn You will learn how: Describe the need for a WBS project Describe the role of WBS in the project Gain hands-on experience in developing, decomposing, and using WBS Determine the appropriate level of detail in the WBS. Explain how the WBS integrates with project requirements, risks, procurement, estimating, planning, and overall project execution. Provide the basic tools to improve the effective reuse of key information in your future projects Getting started Concepts de base WBS & Perimeter WBS & Risks WBS & Estimations WBS & Echéancier WBS & Execution and Mastery Summary and Next Steps
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
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
Virtual Agile Teams: On-Demand Agile teams are a must in this world of intense competition, marketing demands, and changing expectations. Global virtual teaming has become a necessity as organizations become increasingly distributed, with suppliers and clients actively engaged in joint projects. Agile Teams now work across geographical, organizational, and cultural boundaries to deliver solutions and services to global users. Distance and differences may amplify the effect of issues and factors that are relatively straightforward for co-located Agile teams. This workshop delivers practical concepts and techniques that participants will start using immediately with their virtual Agile teams. The goal of the course is to enable you to successfully execute your preferred Agile or Scrum methods in a virtual project team environment. What you will Learn At the end of this program, you will be able to: Explain the characteristics of a virtual team and how they differ from a co-located team Build an effective virtual Agile team using a Team Charter approach Develop Release Plans, including prioritizing user stories, with a virtual Agile Team Construct a Sprint plan, including effective user story estimates, virtually Execute a Sprint, including essential Agile or Scrum ceremonies, virtually Conduct effective virtual meetings in an environment supportive of Agile and Scrum methods Foundation Concepts Agile Mindset and Values Agile Benefits and Methods Scrum Overview Co-located vs. Virtual Teams Forming Virtual Agile Teams Exploring Virtual Leadership Focusing on Virtual Agile Leaders Developing a Virtual Agile Team Charter Meeting Team Challenges in a Virtual Environment Planning Releases with a Virtual Agile Team Planning releases overview Estimating user stories Prioritizing user stories Setting release parameters Getting consensus on the release plan Planning a Sprint for a Virtual Project Sprint Planning Overview Confirming Sprint Scope with Virtual Agile Teams Developing a Sprint Delivery Plan for Virtual Agile Teams Running a Sprint in a Virtual Environment Self-organizing a Sprint for a Virtual Agile Team Using Scrum tools in a Virtual Environment Conducting End of Sprint Meetings in a Virtual Environment Iterating as a Virtual Agile Team Creating an Environment for Success Piloting a virtual Agile team Creating an Agile-friendly virtual environment
Developing the Business Case - Defining the Business Problem and Solution Scope: On-Demand This course teaches the purpose, structure, and content of a business case. It presents the basic techniques for determining financial ROI, non-tangible benefits, and the probability of meeting expectations. What You Will Learn You will learn how to: Prepare a business case Justify the business investment to solve the business need Perform feasibility studies and ROI analyses Foundation Concepts The role of the business analyst An introduction to the BABOK® Guide The business analyst and the product/project life cycle The business case deliverable Introducing the Business Case Process The business analyst and Strategy Analysis The business analyst and the business case process The business analyst during the business case process The business analyst after the business case process Importance of defining solution performance metrics Defining the Business Need Overview of defining the business need Business needs: problem/opportunity statement Product vision Objectives and constraints Exploring Business Case Solutions Overview of exploring solutions Solution identification for feasibility Solution definition for analysis Assessing project risks Justifying the Business Case Overview of justifying the business case Qualitative justification Quantitative justification Approving the Business Case Overview of business case approval Developing recommendations Preparing the decision package - Documents Preparing the decision Package - Presentations