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Course Information Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process. Extending Expertise: Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning. Relevance and Value: Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course.  Key Benefits: Enrich your skill set to: Navigate audit processes encompassing planning, execution, reporting, and follow-up Embrace a personalised approach fostering positive audit outcomes Analyse evidence and present cohesive audit findings Recognise the pivotal role of audits in driving continual improvement. Interactive Learning: Structured to foster dynamic engagement, this course encourages delegates to: Engage in discussions, idea development, and problem-solving Exchange invaluable information and experiences. Hands-On Experience: A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios. Tutors Tutors will be comprised of (click the photos for biographies): Andrew Waddell Founder Director, Tower Mains Ltd Rosemary Ichaba Senior QA Associate, Tower Mains Ltd Cate Ovington Director, The Knowlogy Group Ltd Jean McWilliam Associate Director, Alexion View pop up Programme Please note timings may be subject to alteration. Day 1 08:45 Registration 09:00 Welcome and Course Objectives 09:10 What is 'Audit'? Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements. 09:30 Audits and their Purpose The concepts of quality assurance, quality control, quality management and audit are discussed. 10:30 Break 10:45 Audit Planning The requirements for an effective audit programme and individual audit plans. 11:30 Workshop 1 - Getting the Audit Started Planning for the audit. 12:25 Workshop 1 - Feedback 12:45 Lunch 13:30 Workshop 2 - Getting the Audit Started Arranging the opening meeting. 13:50 Workshop 2 - Feedback Audit initiation. Review and discussion of the role of the opening meeting. 14:25 Auditing Techniques (1) - Data and Documentation Techniques for the conduct of data and report audits are investigated. 14:55 Break 15:10 Workshop 3 - Data and Documentation Audit Conducting an audit of a data package and supporting documentation. 17:15 Close of Day Day 2 09:00 Auditing Techniques (2) - The People Questioning techniques which get the required information from the auditee. 09:45 Live Audit Role Play Auditor and auditee behaviours are explored and strategies developed for successful audit interactions. 10:15 Break 10:35 Audit Closing Meeting An exploration of audit closing meetings. 11:00 Workshop 4 - Audit Observations and Preparing for the Closing Meeting Reviewing and categorising your observations and getting ready to present your case. 11:45 Workshop 4 - Feedback 12:30 Audit Reports The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed. 13:00 Lunch 13:45 Workshop 5 - Audit Reports and Follow-up Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example. 14:30 Workshop 5 - Feedback 14:55 Corrective and Preventive Action and Follow-up The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored. 15:20 Panel Session An opportunity to get answers to outstanding questions. 15:30 Close of Course Extra Information 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. CPD Points 14 Points   Development Level Develop

A forest bathing and mindful stargazing mini-retreat in East Sussex with forest bathing guide Helena Skoog and mindful stargazing expert Mark Westmoquette.

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

Conflict Resolution Skills (In-Person) 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. What you will Learn 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

Virtual Agile Teams 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

Strategic Thinking 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.)

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