Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 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 17 Points Development Level Develop
Introducing Private Counselling Package: Personalized Support for Your Mental and Emotional Well-Being Are you looking for private and confidential support to address personal challenges, improve your emotional well-being, and enhance your overall quality of life? Miss Date Doctor’s Private Counselling Package offers you individualized sessions with experienced therapists who are dedicated to helping you navigate life’s difficulties and achieve personal growth. Private counselling provides you with a safe and supportive environment to explore your thoughts, feelings, and concerns without judgment. Our skilled therapists are committed to understanding your unique needs and providing you with personalized guidance to promote healing and positive change. Here’s how the Private Counselling Package can support you: Personalized Assessment: Our private counsellors will conduct a thorough assessment to gain a comprehensive understanding of your unique challenges and aspirations. Individualized Approach: Your counselling sessions will be tailored to address your specific concerns, ensuring that you receive the most relevant and effective support. Emotional Support: Our therapists provide a compassionate and empathetic space where you can freely express your feelings and experiences. Confidentiality: Private counselling ensures complete confidentiality, allowing you to discuss sensitive topics with confidence and peace of mind. Coping Strategies: We’ll equip you with practical coping strategies to manage stress, anxiety, and other emotional difficulties. Self-Exploration: Private counselling encourages self-discovery and personal growth, helping you gain insights into your thoughts, behaviours, and motivations. Goal Setting: Together with your counsellor, you’ll set achievable goals to work towards positive change and improved well-being. Flexible Sessions: Private counselling offers flexibility in scheduling sessions, making it convenient for your busy lifestyle. The Private Counselling Package at Miss Date Doctor is designed to provide you with personalized support and guidance on your journey to emotional well-being and personal growth. Our skilled therapists are committed to helping you overcome challenges, enhance your resilience, and lead a more fulfilling life. Invest in your mental and emotional health and take the first step towards positive change with the Private Counselling Package. Embrace the opportunity to explore your thoughts and feelings in a confidential and supportive environment. Let our experienced counsellors guide you towards a brighter and more empowered future. 3 x 1 hour https://relationshipsmdd.com/product/private-counselling-package/
Introducing Therapy for Relationship Issues Package: Strengthening Bonds and Nurturing Healthy Connections Are you and your partner facing challenges in your relationship and seeking professional support to improve communication, resolve conflicts, and strengthen your bond? Miss Date Doctor’s Therapy for Relationship Issues Package offers you expert guidance to navigate difficulties, foster intimacy, and build a healthier, more fulfilling partnership. Relationships can encounter various obstacles that impact communication, trust, and emotional connection. Our experienced therapists specialize in working with couples and are dedicated to helping you and your partner overcome challenges and cultivate a more loving and harmonious relationship. Here’s how the Therapy for Relationship Issues Package can support you: Effective Communication: Our therapists will help you and your partner improve communication skills, fostering a deeper understanding of each other’s needs and emotions. Conflict Resolution: Relationship therapy addresses conflict resolution strategies, assisting you in navigating disagreements constructively and preventing recurring conflicts. Rebuilding Trust: If trust has been compromised, our therapists will guide you in rebuilding trust and creating a more secure emotional bond. Emotional Intimacy: We’ll explore ways to enhance emotional intimacy and create a more fulfilling emotional connection between you and your partner. Addressing Past Issues: Relationship therapy can address unresolved issues from the past that may be affecting your present relationship dynamics. Identifying Patterns: Our therapists will help you and your partner identify negative patterns of behaviour or communication, fostering healthier interactions. Shared Goals: We’ll assist you in exploring and aligning your shared goals and aspirations, ensuring that you are on the same page about your future together. Renewing Affection: Therapy for relationship issues can help rekindle affection and emotional closeness between you and your partner. The Therapy for Relationship Issues Package at Miss Date Doctor is designed to empower you and your partner to build a stronger foundation for your relationship. Our skilled therapists provide a safe and supportive space for open and honest dialogue, allowing you to work towards a more fulfilling and harmonious partnership. Invest in the well-being of your relationship and take the first step towards a healthier and more loving connection with the Therapy for Relationship Issues Package. Embrace the opportunity to strengthen your bond, improve communication, and create a lasting and satisfying relationship. Let our experienced therapists guide you and your partner towards a brighter future filled with love, understanding, and mutual support. 3 x 1 hour sessions https://relationshipsmdd.com/product/therapy-for-relationship-issues-package/
Disciplined Agile Scrum Master (DASM): Virtual In-House Training Is your team treading water using waterfall? Do you feel trapped in an agile framework? Would you like to find solutions to the problems you've been wrestling with? Are you looking for ways to enhance your team's agility? Break free from your old ways by choosing a way of working that fits your team's context. Find strategies to improve your processes and strengthen your team with the Disciplined Agile® tool kit. Disciplined Agile Scrum Master is a nine-lesson, instructor-led course that shows you how to use Disciplined Agile (DA™) to improve your team's way of working. In just two days, you will become familiar with foundational agile and lean practices that DA supports, practice using the tool kit to solve problems, and learn how to build high-performance teams. Filled with activities, animations, supplemental reading, and more, this course will prepare you to take the Disciplined Agile Scrum Master (DASM) exam and, equally important, start using Disciplined Agile immediately. #BBD0E0 » What You Will Learn After the completion of this course, you will be able to: Apply foundational agile and lean practices in your own team setting Describe what business agility is and how it is core to value proposition of Disciplined Agile® Describe the significance of the Disciplined Agile mindset Define the DA™ principles, promises, and guidelines and how they set Disciplined Agile apart from other frameworks Explain how people are organized into DA teams Define the primary DA roles and how they each are key to the success of a self-organizing agile team Explain how to help your team work well together using the Lean principle of 'respect people' Analyze your team's context to make better process-related decisions Select the best-fit DA life cycles for your teams Apply the five DA steps of choosing your team's way of working (WoW) Apply the relevant agile and lean techniques to successfully initiate your team Apply the relevant agile and lean techniques to support your team producing business value Apply the relevant agile and lean techniques to support your team releasing their work into production Apply the relevant agile and lean techniques to support your team on an ongoing basis Recognize when to be resilient List and define the principles of Lean Significance of the Disciplined Agile® Mindset Business agility and how it is core to value proposition of Disciplined Agile Eight DA principles and how they are core to what sets Disciplined Agile apart from other agile frameworks Which situations each of the DA™ life cycles is best applied DA Practice of choosing a team's way of working (WoW) Foundations of Agile How people are organized into DA teams Primary DA roles and how they each are key to the success of a self-organizing agile team Help your team work well together (Lean principle 'Respect people') Inception phase and why it is important DA tool kit to tailor your way of working within a select phase according to context Agile techniques and ceremonies relevant to Inception Construction phase and why it is important Agile techniques and ceremonies that take place during Construction Eliminate Waste and Build Quality (Lean principles) Deliver Value Quickly (Lean principle) Transition phase and why it is important Ongoing phase and why it is important Learn Pragmatically (Lean principle) Elements of the process blade (onion) diagram Principles of Lean When to be resilient Benefits of explicit workflow Kaizen loops and PDSA techniques for continuous improvement Options for cross-team learning: "community of practice" and "center of excellence"
Disciplined Agile Scrum Master (DASM): In-House Training Is your team treading water using waterfall? Do you feel trapped in an agile framework? Would you like to find solutions to the problems you've been wrestling with? Are you looking for ways to enhance your team's agility? Break free from your old ways by choosing a way of working that fits your team's context. Find strategies to improve your processes and strengthen your team with the Disciplined Agile® tool kit. Disciplined Agile Scrum Master is a nine-lesson, instructor-led course that shows you how to use Disciplined Agile (DA™) to improve your team's way of working. In just two days, you will become familiar with foundational agile and lean practices that DA supports, practice using the tool kit to solve problems, and learn how to build high-performance teams. Filled with activities, animations, supplemental reading, and more, this course will prepare you to take the Disciplined Agile Scrum Master (DASM) exam and, equally important, start using Disciplined Agile immediately. #BBD0E0 » What You Will Learn After the completion of this course, you will be able to: Apply foundational agile and lean practices in your own team setting Describe what business agility is and how it is core to value proposition of Disciplined Agile® Describe the significance of the Disciplined Agile mindset Define the DA™ principles, promises, and guidelines and how they set Disciplined Agile apart from other frameworks Explain how people are organized into DA teams Define the primary DA roles and how they each are key to the success of a self-organizing agile team Explain how to help your team work well together using the Lean principle of 'respect people' Analyze your team's context to make better process-related decisions Select the best-fit DA life cycles for your teams Apply the five DA steps of choosing your team's way of working (WoW) Apply the relevant agile and lean techniques to successfully initiate your team Apply the relevant agile and lean techniques to support your team producing business value Apply the relevant agile and lean techniques to support your team releasing their work into production Apply the relevant agile and lean techniques to support your team on an ongoing basis Recognize when to be resilient List and define the principles of Lean Significance of the Disciplined Agile® Mindset Business agility and how it is core to value proposition of Disciplined Agile Eight DA principles and how they are core to what sets Disciplined Agile apart from other agile frameworks Which situations each of the DA™ life cycles is best applied DA Practice of choosing a team's way of working (WoW) Foundations of Agile How people are organized into DA teams Primary DA roles and how they each are key to the success of a self-organizing agile team Help your team work well together (Lean principle 'Respect people') Inception phase and why it is important DA tool kit to tailor your way of working within a select phase according to context Agile techniques and ceremonies relevant to Inception Construction phase and why it is important Agile techniques and ceremonies that take place during Construction Eliminate Waste and Build Quality (Lean principles) Deliver Value Quickly (Lean principle) Transition phase and why it is important Ongoing phase and why it is important Learn Pragmatically (Lean principle) Elements of the process blade (onion) diagram Principles of Lean When to be resilient Benefits of explicit workflow Kaizen loops and PDSA techniques for continuous improvement Options for cross-team learning: "community of practice" and "center of excellence"
Project Management Office The goal of this course is to equip the participant with the necessary knowledge and skills to establish, improve, and support a project management office (PMO) that is the catalyst for portfolio and delivery management excellence. This course addresses the complexities of both understanding and choosing the correct PMO framework from among several alternatives. Additionally, the typical PMO supporting elements: domains of work, maturity level, and performance metrics, are elaborated. These elements position a PMO to realize and sustain the business value anticipated by the organization. What You Will Learn At the end of this program, you will be able to: Define a PMO and articulate on its benefits to an organization Explain how a PMO facilitates organizational success Differentiate among the varied PMO frameworks Apply to a PMO framework, domains of work, metrics, and organizational maturity Describe the competency frameworks for management functions within a PMO Plan for and implement a PMO to ensure it is of business value Foundation Concepts Definitions and concepts PMO frameworks PMO domains PMO benefits PMO Frameworks Organizational unit PMO Project-specific PMO Project support or services PMO Center of excellence Enterprise PMO PMO Domains I Strategic planning Standards, methodologies, and processes Governance and performance management Organizational change management PMO Domains II Portfolio management Project and program delivery management Administrative support, knowledge, and talent management PMO Metrics and Maturity PMO metrics PMO maturity PMO maturity assessments PMO Implementation Originating and initiating a PMO Developing a PMO implementation plan Implementing a PMO
Scrum Master Workshop A Scrum Master helps project teams properly use the Scrum framework, increasing the likelihood of the project's overall success. Scrum Masters understand Scrum values, practices, and applications and provide a level of knowledge and expertise above and beyond that of typical project managers. Scrum Masters act as 'servant leaders', helping the rest of the Scrum Team work together and learn the Scrum framework. Scrum Masters also protect the team from both internal and external distractions. What you will Learn You'll learn how to: Comprehend the Agile Manifesto and mindset Explain the fundamental principles of Scrum Guide the Scrum team in their responsibilities Write requirements in the form of user stories Define Ready and Done Estimate using planning poker and prioritize using MoSCoW Facilitate the team through the 5 Sprint events Fulfill the role of Scrum Master in a Scrum project Create Information Radiators to enable transparency Define the structure of the retrospective Foundation Concepts Agile History, Values, and Mindset Introduction to Scrum Scrum events Scrum artifacts Scrum Roles and Responsibilities Product Owner responsibilities Scrum Master responsibilities The Team responsibilities Cross-functional Teams Building Effective Teams The Product Backlog and User Stories The Product Backlog User Stories Definition of Done Backlog grooming Estimating User Stories Story points, planning poker Prioritizing User Stories The Sprint Team capacity and velocity The Sprint Planning Meeting The Sprint Backlog The Sprint Learning to self-manage, self-organize, self-improve Sprint Review and Retrospective Project Progress and Completion The Daily Scrum The Task Board and The Burndown Chart Information Radiators Closing a Scrum Project Summary and Next Steps Review of course goals, objectives, and content
Scrum Master Workshop: In-House Training A Scrum Master helps project teams properly use the Scrum framework, increasing the likelihood of the project's overall success. Scrum Masters understand Scrum values, practices, and applications and provide a level of knowledge and expertise above and beyond that of typical project managers. Scrum Masters act as 'servant leaders', helping the rest of the Scrum Team work together and learn the Scrum framework. Scrum Masters also protect the team from both internal and external distractions. What you will Learn You'll learn how to: Comprehend the Agile Manifesto and mindset Explain the fundamental principles of Scrum Guide the Scrum team in their responsibilities Write requirements in the form of user stories Define Ready and Done Estimate using planning poker and prioritize using MoSCoW Facilitate the team through the 5 Sprint events Fulfill the role of Scrum Master in a Scrum project Create Information Radiators to enable transparency Define the structure of the retrospective Foundation Concepts Agile History, Values, and Mindset Introduction to Scrum Scrum events Scrum artifacts Scrum Roles and Responsibilities Product Owner responsibilities Scrum Master responsibilities The Team responsibilities Cross-functional Teams Building Effective Teams The Product Backlog and User Stories The Product Backlog User Stories Definition of Done Backlog grooming Estimating User Stories Story points, planning poker Prioritizing User Stories The Sprint Team capacity and velocity The Sprint Planning Meeting The Sprint Backlog The Sprint Learning to self-manage, self-organize, self-improve Sprint Review and Retrospective Project Progress and Completion The Daily Scrum The Task Board and The Burndown Chart Information Radiators Closing a Scrum Project Summary and Next Steps Review of course goals, objectives, and content
Portfolio Management for Stakeholders: In-House Training This course equips and enables project, program, and functional managers (line managers) to support and contribute to starting, restarting or sustaining the implementation and effectiveness of portfolio management in an organization. Emphasis is on improving collaboration and planning between functional business areas and project/program organizations responsible for delivering investments in business change through successful delivery of projects and programs. Good functional, project, and program managers become 'great' when they understand, advocate, and effectively contribute to achieving 'real' business value through portfolio management. What you Will Learn At the end of this program, you will be able to: Outline the benefits of portfolio management State the importance of linking the strategic objectives to the initiatives in the organization Chart the portfolio governance structure Assist in the inventory of ongoing and new initiatives Identify portfolio and sub-portfolio categories Support the PMO in the prioritization of initiatives using Multi-criteria Analysis and other selection tools Collaborate with the PMO in balancing the portfolio based on the optimal use of resources and priorities Participate in resource forecasting and planning Demonstrate thresholds and variance reporting criteria Describe the purpose of Stage Gate Funding Report status against a portfolio delivery plan Present your initiative in Stage Gate Reviews List the benefits that are being realized by the initiative Foundation Concepts Portfolio Life Cycles Portfolio Governance Prioritizing Initiatives Prioritize Foundation Multi-Criteria Analysis Analytical Hierarchy Process (AHP) Strategic Alignment Balancing the Portfolio Resources, Budgets, and Equipment Communicating Decisions Planning the Portfolio Planning Review Cycles Using Stage Gate Funding Setting Thresholds and Variance Reporting Tool Examples Portfolio Delivery 'Cycle' Project and Program Life Cycles Stage Gate Reviews Interaction with the Portfolio Delivery Board Project, Program, and Functional Managers Roles and Responsibilities
Portfolio Management for Stakeholders This course equips and enables project, program, and functional managers (line managers) to support and contribute to starting, restarting or sustaining the implementation and effectiveness of portfolio management in an organization. Emphasis is on improving collaboration and planning between functional business areas and project/program organizations responsible for delivering investments in business change through successful delivery of projects and programs. Good functional, project, and program managers become 'great' when they understand, advocate, and effectively contribute to achieving 'real' business value through portfolio management. What you Will Learn At the end of this program, you will be able to: Outline the benefits of portfolio management State the importance of linking the strategic objectives to the initiatives in the organization Chart the portfolio governance structure Assist in the inventory of ongoing and new initiatives Identify portfolio and sub-portfolio categories Support the PMO in the prioritization of initiatives using Multi-criteria Analysis and other selection tools Collaborate with the PMO in balancing the portfolio based on the optimal use of resources and priorities Participate in resource forecasting and planning Demonstrate thresholds and variance reporting criteria Describe the purpose of Stage Gate Funding Report status against a portfolio delivery plan Present your initiative in Stage Gate Reviews List the benefits that are being realized by the initiative Foundation Concepts Portfolio Life Cycles Portfolio Governance Prioritizing Initiatives Prioritize Foundation Multi-Criteria Analysis Analytical Hierarchy Process (AHP) Strategic Alignment Balancing the Portfolio Resources, Budgets, and Equipment Communicating Decisions Planning the Portfolio Planning Review Cycles Using Stage Gate Funding Setting Thresholds and Variance Reporting Tool Examples Portfolio Delivery 'Cycle' Project and Program Life Cycles Stage Gate Reviews Interaction with the Portfolio Delivery Board Project, Program, and Functional Managers Roles and Responsibilities