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
Certified Scrum Professional®-ScrumMaster® (CSP®-SM): In-House Training Certified Scrum Professionals challenge their teams to improve the way Scrum and Agile principles are applied. They have demonstrated experience, documented training, and proven knowledge in Scrum. Are you ready to take your knowledge and skillset in your role as Scrum Master to the next level? If so, it's time to elevate your career further by earning the Certified Scrum Professional®-ScrumMaster (CSP®-SM) certification. What you will Learn Learn to find practical solutions and improve your implementation of Scrum in the workplace. Aside from the pride gained and earning potential of attaining CSP® level, you can also: Attend exclusive CSP® events with other leaders in Scrum and Agile Attract more recruiters and command a higher rate of pay Establish a gateway and milestone toward becoming CST®, CEC, or CTC Receive a free premium subscription to the world's largest Agile assessment and continuous improvement platform, Comparative Agility®
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
Building High-Performance Teams: In-House Training This course pulls together the most current and popular theories and writings on this complex topic and presents this amalgamated view in a highly interactive workshop and activity-based approach. Students will understand and have the skills required to build and participate in high-performance project teams and will possess the insight to proactively affect change within their respective organizations by guiding the existing culture to one that promotes high performance. What you will Learn At the end of this program, you will be able to: Define a team and describe the optimum team size for effective performance Describe characteristics and guiding behaviors of high-performance teams Describe the major elements of each development stage in two distinct models Recognize cultural barriers in achieving high performance List the attributes of a high-performing corporate culture Assess your own corporate culture Discuss corporate leadership as a factor in building high-performance project teams Describe the three A's of selecting team members State three leadership responsibilities Describe leadership responsibilities, styles, and roles List and describe the eight components of the team charter model for building high-performance teams Foundation Concepts The Nature of Teams Characteristics of High-Performance Teams Understanding Team Development Stages of Team Development - Model 1 Stages of Team Development - Model 2 Designing a High-Performance Culture Corporate Cultures Corporate Leadership Establishing the Attributes of High Performance Choosing the Right People Team Effectiveness Team Leadership The Team Charter Model
NPORS Rigging and Fleeting Loads Lift Planner (N046)
This programme is aimed at helping participants to manage their time more effectively and to be more productive with the time available to them.
SMART Improvement Planning & Implementation
SAFe® Agile Software Engineering: In-House Training The introduction of Lean-Agile and DevOps principles and practices into software engineering has sparked new skills and approaches that help organizations deliver higher-quality, software-centric solutions faster and more predictably. This workshop-oriented course explores foundational principles and practices and how continuous flow of value delivery and built-in quality are enabled by XP technical practices, Behavioral-Driven Development (BDD), and Test-Driven Development (TDD). Attendees will learn proven practices to detail, model, design, implement, verify, and validate stories in the SAFe® Continuous Delivery Pipeline, as well as the practices that build quality into code and designs. Attendees will also explore how software engineering fits into the larger solution context and understand their role in collaborating on intentional architecture and DevOps. What you will Learn To perform the role of a SAFe® Agile Software Engineer, you should be able to: Define Agile Software Engineering and the underlying values, principles, and practices Apply the Test-First principle to create alignment between tests and requirements Create shared understanding with Behavior-Driven Development (BDD) Communicate with Agile modeling Design from context for testability Build applications with code and design quality Utilize the test infrastructure for automated testing Collaborate on intentional architecture and emergent design Apply Lean-Agile principles to optimize the flow of value Create an Agile Software Engineering plan Introduction to Agile Software Engineering Connecting Principles and Practices to Built-in Quality Accelerating Flow Applying Intentional Architecture Thinking Test-First Discovering Story Details Creating a Shared Understanding with Behavior-Driven Development (BDD) Communicating with Models Building Systems with Code Quality Building Systems with Design Quality Implementing with Quality
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Agile Business Consortium Scrum Master® Course: In-House Training This two-day course covers the principles and theory of the Scrum framework and the role of the Scrum Master. IIL is an accredited training organization (ATO) and the course is delivered by accredited trainers. APMG's accreditation processes are respected globally and accredited by UKAS. A Scrum Master is responsible for promoting and supporting Scrum as defined in The Scrum Guide, and also is the leader who serves the Product Owner, the Development Team, and the Organization. Why APMG - Agile Business Consortium Scrum Master® Course and Certification? The course, syllabus, and learning objectives are based on The Scrum Guide - The Definitive Guide to Scrum: The Rules of the Game - created and maintained by Scrum's creators Ken Schwaber and Jeff Sutherland Increased business (non-IT) focus of course and exercises Developed in partnership with Agile Business Consortium - leaders in promoting and enabling business agility Course is highly interactive to encourage collaboration and reinforce learning objectives Candidates can sit the examination at the end of the training course No recertification requirements. APMG Scrum Master certification does not expire. Successful candidates are entitled to free 1-year membership with the Agile Business Consortium Successful candidates can claim a digital badge and share their success online What You Will Learn At the end of this program, you will be able to: Gain a deep understanding of the Scrum Framework - the theory, practices, roles, rules, and values - as defined in The Scrum Guide Understand, in detail, the role of Scrum Master, and how the role interacts with different members of the Scrum Team and other stakeholders Master the Scrum principles to better understand their application when returning to the workplace Understand how to construct an effective development team with an appropriate mix of skills and experience Know how to act as a servant-leader for the Scrum Team, promoting and enabling self-organization to create high-value products. Learn how to facilitate Scrum Events and remove impediments to the Scrum Team's progress Help Scrum Product Owners shape and refine product backlogs to guide early and incremental delivery of valuable products Drive adoption of the Scrum framework for more effective product and solution development, working with stakeholders and other Scrum Masters to improve its effectiveness Day One Scrum Overview Self-Organization Agile Principles Empirical Product Development Scrum Events The Development Team Scrum Roles Day Two The Product Backlog Sprint Planning and Done Sprint Progress Scrum Simulation Growing as a Scrum Master