11119 Courses

Course Information Embark on our GLP course offering extensive guidance and pragmatic support tailored for individuals serving as Study Directors or Principal Investigators overseeing non-clinical safety studies on pharmaceuticals, agricultural, and industrial chemicals within the realm of Good Laboratory Practice (GLP). This comprehensive programme extends its benefits to study staff and management operating in GLP-compliant environments. The course extensively covers the current OECD GLP Principles and UK GLP legislation, while also referencing international standards, regulations, and guidelines pertinent to the field. Benefits of this course: Practical help and guidance on the interpretation and application of GLP An opportunity to update your knowledge of GLP with the current interpretation of requirements Access to an experienced panel of speakers Information on how other organisations address GLP issues An opportunity to improve your understanding of the GLP requirements as they are applied in different situations. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of GLP Learn from the experience of others. Tutors Tutors will be comprised of (click the photos for biographies): Tim Stiles Consultant, Qualogy Ltd Tony Woodall Head of Quality Assurance, Alderley Analytical Gill Armour Study Monitor Team Leader, AstraZeneca Jane Elliston Senior Quality Assurance Auditor, Battelle UK Vanessa Grant -, - Jeanet Logsted CEO, Scantox Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:15 Welcome and Introductions 09:35 Development of Good Laboratory Practice A review of the history of GLP, its current scope and application, with a synopsis of current European and international standards. 10:05 Roles and Responsibilities The responsibilities of study director, test facility, management and study staff in the conduct of a GLP study. 10:45 Break 11:00 The Roles and Responsibilities of the Study Director and Test Facility Management The role of the study director in the management and control of a study, as defined by GLP, and management's roles are explored. 11:45 Multi-site Studies What is a multi-site study and when should such concepts be applied on a study. The role of the study director and principal investigator in the planning, conduct and reporting of multi-site study are explored. 12:30 Study Plan (Protocols) GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed. 13:00 Lunch 13:45 Workshop 1 - The Study Plan Some practical problems with study plans and amendments explored. 14:45 Workshop 1 - Feedback 15:00 Standard Operating Procedures The control, content and authorisation of SOPs and the principles behind the practice. 15:30 Break 15:45 Workshop 2 - Practical Study Conduct Problems Dealing with practical problems encountered during the conduct of studies. 16:40 Workshop 2 - Feedback 17:15 Close of Day Day 2 09:00 Questions and Answers Discussion of issues raised by course delegates. 09:20 Quality Assurance The interactions between QA, management, study director and principal Investigator are discussed as is QAs role when conducting a multi-site study. 10:00 The Final Report The content of the final report and the role of those involved in its preparation and approval. Specific reporting requirements when conducting a multi-site study are also explained. 10:30 Break 10:45 Workshop 3 - Final Report Problems Practical problems of report preparation including compliance statements. 11:30 Workshop 3 - Feedback 12:00 Management of Raw Data and Records A view on how records and materials are managed and archived in compliance with GLP. 12:45 Lunch 13:30 Workshop 4 - Data and Sample Management Issues Dealing with data and sample management issues. 14:15 Workshop 4 - Feedback 14:45 Regulatory Inspection Government monitoring for compliance with Good Laboratory Practice. 15:15 Panel Session This panel session will address any outstanding issues raised by delegates. 15:45 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

Course Information Our extensively proven course delves into the essential stages of process and system auditing. Gain invaluable insights and direction in auditing systems and processes, spanning across global and local organisational levels. This course will assist delegates with: A practical approach for the development and conduct of process and system audits An enhanced understanding of key system audit principles, preparation, design and conduct Increased expertise, efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Share knowledge and experiences. By the end of the course delegates will be better able to: Design and plan more effectively to achieve their process and systems audit objectives and add value to their organisation Improve the effectiveness, focus and credibility of the audit programme Understand the key system audit principles, preparation, design and conduct Develop system audit tools to ensure more effective audit conduct and outcome Create audit strategies utilising risk management principles Prepare for inspections. Tutors Tutors will be comprised of (click the photos for biographies): Allison Jack Executive Director, Bristol Myers Squibb Rocio Castellanos Director, Pfizer Ltd Guy Houben G(C)LP Auditor, Janssen Pharmaceutical Companies of Johnson & Johnson Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introductions, Expectations/Challenges/Experiences A discussion to explore the range of approaches to the conduct of systems audit. 09:30 Introducing Systems Audit What is a system? Why conduct system audits? Advantages, disadvantages and challenges. 10:20 Break 10:35 Systems Audit Design and Planning Identifying the customer, setting objectives, development of the audit plan and audit tools, plans for the audit report. 12:00 Designing System Audit Tools 12:45 Lunch 13:30 System Audit Plan - Exercise 14:00 Introduction to Case Studies The objectives of the case studies are defined and process and outputs described. 14:15 Case Studies - Session 1 A first opportunity for work on case studies. Defining objectives and scope and understanding the requirements of the audit client. 15:00 Break 15:20 Case Studies - Session 1 continued 16:30 Case Studies - Feedback 17:00 Close of Day 1 Day 2 09:00 Simple System Audit Example - Introduction The objectives of the case studies are defined and process and outputs described. 09:10 Case Studies - Session 2 - A Simple System Audit Example An example of system audit applied to a simple system. 10:30 Break 10:45 A Simple System Audit Example - Case Study Feedback 11:30 Strategy Audit programme planning. 12:15 Lunch 13:00 Case Studies - Session 3 Work on delegate's case studies. 14:30 Break 14:45 Case Studies - Session 3 - Feedback 15:15 Closing remarks 15:30 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

Strategic Thinking (In-Person) 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 You will learn how to: 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.)

Building High-Performance Teams 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.

Decision Making and Problem Solving (In-Person) We may live in an era of fast technology and increasing reliance upon automation, but our human abilities to think critically, make careful decisions, and solve nuanced problems are more important than ever. Our personal lives depend on those things, and so do the lives of our organizations. Since business is now conducted at remarkable speeds, we put our organizations at great risk daily when we have weak competencies with decision-making and problem-solving. Decisions and solutions that are executed impulsively and without structured approaches can create more problems or make existing ones worse! This course aims to help participants improve their skills so they can execute well and add value to the workplace. Learners will experience multiple decision-making and problem-solving models, tools, and techniques meant for the real world. They will learn how to align their growing toolboxes with the right situational contexts so that they can transfer that skill to the workplace. They will also discover how indecision, cognitive bias, and default thought processes can create obstacles to effective decision-making and problem-solving. What you will Learn Recognize the importance of making a sound decision in a timely manner Infer types of cognitive biases and obstacles that impact decision-making Separate facts, requirements, ideas, and perceptions when making a decision or solving problems Apply structured decision-making and problem-solving approaches Conduct cause and effect and Force Field analyses Evaluate alternative solution methods using various techniques Analyze real world situations to determine the best aligned decision-making and problem-solving models, tools, and techniques Implement decision-making and problem-solving models, tools, and techniques Getting Started Foundation Concepts Contextualizing decisiveness and problem-solving Discriminating between decisiveness and problem-solving Understanding Decision-Making Decision-making challenges and impacts Key drivers of good decision-making Thought processes and obstacles Knowledge, skills, and abilities (KSAs) Decision-Making Models and Supporting Tools Decision-making models, tools, and guidelines Tools to evaluate alternatives Translating requirements into action Problem-Solving Defining the problem Problem-solving models Cause and effect analysis Quick hit vs. innovative problem-solving Summary and Next Steps Course summary Personal action plan

Effective Negotiation Skills for Business Success (In-Person) Become skillful at dealing with unworkable differences - situations where there appears to be no acceptable compromise or acceptable solution. This interactive workshop shows you how to work towards agreements where all parties are satisfied that they have reached a wise outcome efficiently, and where they can come back to the table in the future because the relationship is intact. You will have the opportunity to re-visit a difficult / challenging negotiation that you experienced in the past as well as take part in progressively more challenging case studies that are tailored to the work you do. You will enhance your personal and professional life with powerful new negotiating skills. The goal of this workshop is to improve your negotiation skills by helping you to identify your own preferred negotiation style and strategies, and to learn about the need to plan for any upcoming negotiation. The workshop is also designed for you to experience typical negotiation situations at certain key points of the life cycle of a project, enabling you to develop an awareness of your effectiveness during negotiations at these stages. The majority of time is spent on practicing newly presented negotiation techniques and receiving feedback on application for further development and improvement. What you will Learn At the end of this program, you will be able to: Identify your preferred negotiation style and strategies Examine the Principled Negotiation Model Adapt your negotiation strategy to the progress of the negotiation Experience typical negotiation situations during the life cycle of a project Develop an awareness of your effectiveness during negotiations Improve your negotiation skills Negotiation Model Negotiation defined Negotiation phases Common approaches to negotiating Principled Negotiating Principled negotiation and the four rules Best alternative to a negotiated agreement Project Negotiation Simulation: Part 1 and Part 2 Project Negotiation Simulation: Part 1 Project Negotiation Simulation: Part 2 Negotiating Cases Negotiating cases Summary and Next Steps

Project Stakeholder Relationship Skills (In-Person) This course is designed to provide project managers with the ability to: Analyze the complexities of major stakeholder relationship categories Apply the most appropriate interpersonal relationship skills to the different categories of relationships Align the dynamic needs of the stakeholders with a project's objective throughout the project life cycle What You Will Learn You'll learn how to: Examine traditional and non-traditional ways to identify and assess stakeholders Explain how competence, character, and trust lead to project success and strong relationships with stakeholders Utilize 'Embodied Leadership' skills to build stakeholder relationships Apply stakeholder engagement best practices to case study and real-life scenarios Foundation Concepts Stakeholders and project success Stakeholder management research Managing stakeholder relationships Identifying Stakeholders Stakeholder categories Stakeholder relationships across the project life cycle Tools and techniques for identifying stakeholders Assessing Stakeholders Assessing stakeholder relationships Recognizing stakeholder attitudes toward the project Analyzing stakeholders Using other types of stakeholder assessments Building Stakeholder Relationships The importance of psychological safety Building trust and getting results The anatomy of trust Navigating Challenging Situations Dynamics of conflict Responding to conflict Managing difficult conversations

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

Introduction to Design Thinking Innovation is the cornerstone of highly successful companies, especially those that continue to be successful over the years and decades. Design thinking practices fuel this continual innovation, as they are the critical links from inspiration to delivery, concept to showroom floor, and start-up to global business. Design thinking is a structured approach to promoting innovation and creative problem-solving. It is not a new approach. It has been around for centuries, as the art, architecture, and inventions of mankind illustrate. By examining the steps to achieving great design and maximum utility of product, design thinking approaches provide a framework in which to develop new solutions to problems and new products to sell. This highly interactive course is designed to help participants think like designers to generate innovation, and to help teams to produce more innovation and creativity. Since design thinking is based on doing rather than thinking, we participants are challenged to apply the techniques, in the classroom, to create new ideas and solutions to a case study project. What you will Learn At the end of this program, you will be able to: Explain the underlying principles and value of using Design Thinking for innovation Describe the basic concepts of the Stanford Model for Design Thinking Evaluate a set of basic Design Thinking techniques for application to your projects Apply tools, techniques, and skills aligned with the 5 stages of the Stanford Model Drive innovation through Design Thinking at some level in your work environment Foundation Concepts Problems and solutions The Design Thinking difference Design Thinking skills and abilities Design Thinking mindset Design Thinking frameworks Stages of Design Thinking Problems and solutions The Design Thinking difference Design Thinking skills and abilities Design Thinking mindset Design Thinking frameworks General Practices Team formation Visualization Improvisation Personalization Empathize Practices Overview of Empathize techniques Observation Engagement Interviews Define Practices Overview of Define practices Unpacking techniques Defining the customer techniques Integrating the Define experience Ideate Practices Overview of Ideate practices Reusable techniques for the Ideate stage New Ideate techniques to explore Prototype & Test Practices Overview of Prototype practices Examples of prototypes Overview of Testing practices Forms of testing techniques Adopt and Adapt Design Thinking Overview of Design Thinking implementation Design Thinking implementation challenges Success in implementing Design Thinking Summary and Next Steps Workshop summary Next steps: Personal Action Plans

Project Stakeholder Relationship Skills This course is designed to provide project managers with the ability to: Analyze the complexities of major stakeholder relationship categories Apply the most appropriate interpersonal relationship skills to the different categories of relationships Align the dynamic needs of the stakeholders with a project's objective throughout the project life cycle What you Will Learn Examine traditional and non-traditional ways to identify and assess stakeholders Explain how competence, character, and trust lead to project success and strong relationships with stakeholders Utilize 'Embodied Leadership' skills to build stakeholder relationships Apply stakeholder engagement best practices to case study and real-life scenarios Getting Started Stakeholders and project success Stakeholder management research Managing stakeholder relationships Identifying Stakeholders Stakeholder categories Stakeholder relationships across the project life cycle Tools and techniques for identifying stakeholders Assessing Stakeholders Assessing stakeholder relationships Recognizing stakeholder attitudes toward the project Analyzing stakeholders Using other types of stakeholder assessments Building Stakeholder Relationships The importance of psychological safety Building trust and getting results The anatomy of trust Navigating Challenging Situations Dynamics of conflict Responding to conflict Managing difficult conversations