Duration 3 Days 18 CPD hours This course is intended for This course is intended for beginner to intermediate business and requirements analysts who are looking to improve their elicitation and requirements writing and documentation skills. This course is also a great fit for technical writers, product and software testers, project managers, product owners who work closely with business analysts or who perform some for of business analysis themselves. Overview Understand the role of the business analyst and core competencies for performing successfully Discuss the criticality of business analysis and requirements for successful project outcomes Understand the main professional associations and standards supporting business analysts in the industry Discuss the common problems with requirements and explore approaches to address these issues Obtain a clear understanding of the various requirements types and the significance for eliciting each type Demonstrate your ability to identify stakeholders Explore various methods for understanding and analyzing stakeholders Discuss and apply good planning practices to requirements elicitation efforts Obtain knowledge and understanding of over 15 current and commonly applied elicitation techniques Understand how to progress from elicitation to analysis to documentation Write well-formed and validated requirements Gain understanding of the best practices for writing quality requirements Learn the technical writing techniques that apply directly to writing requirements documents Discuss writing pitfalls, risks that impact requirements, and how to address them Learn best practices for communicating and collaborating with stakeholders, sharing the results of elicitation and the resulting documentation Learn approaches for validating requirements Understand the difference between validating requirements and validating the solution With elicitation serving as a major component of the requirements process, it is imperative that business analysts maintain high competency levels in elicitation practices and technique use to help organizations overcome the requirements related challenges faced on projects. Regardless whether you are a practitioner just starting off your career in business analysis or whether you have been performing the role for some years, this course will provide insight into the latest thoughts on elicitation and writing effective requirements and present a number of current techniques that are being applied on projects across industries today. Review of Foundational Concepts Definition of a business analysis Definition of business analyst BA role vs. PM role Business analysis competencies Benefits of business analysis Purpose for having a BA standard IIBA?s BABOK© Guide and PMI?s Practice Guide in Business Analysis Business analysis core concepts Discussion: Project challenges Understanding Requirements Common problems with requirements Understand the problem first Define the business need Situation statements and moving to requirements Understanding requirement types Business requirements Stakeholder/User Requirements Solution Requirements Functional Requirements Non-Functional Requirements Assumptions and Constraints Discussions: Requirement problems, business needs, and identifying non-functional requirements Discovering Stakeholders Definition of a stakeholder Stakeholder types Identifying stakeholders Performing stakeholder analysis Stakeholders and requirements Tips for identifying stakeholders Grouping stakeholders Creating a RACI model Tips for analyzing stakeholders Documenting results of stakeholder analysis Workshop: Discovering stakeholders Preparing for Requirements Elicitation Planning for elicitation Benefits of elicitation planning What do you plan? The elicitation plan Setting objectives for elicitation Determining the scope for elicitation Establishing pre-work Determining the outputs for the session The iterative nature of elicitation Elicitation roles Elicitation planning techniques Discussions: Who to involve in elicitation, planning impacts, and unplanned elicitation Workshop: Planning for elicitation Conduct Requirements Elicitation Elicitation skillset Types of elicitation techniques Using active listening in elicitation Techniques for performing elicitation Benchmarking/Market Analysis Brainstorming Business Rules Analysis Collaborative Games Concept Modeling Data Mining Data Modeling Document Analysis Focus Groups Interface Analysis Interviews Observation Process Modeling Prototyping Survey or Questionnaire Workshops Write Effective Requirements Elicitation and Analysis Requirements related issues Implications of bad requirements Elicitation and documentation Writing skillset Documenting requirements Modeling requirements Defining the project life cycle Impact of project life cycle on documentation Requirements specifications Characteristics of good requirements Guidelines for writing textual requirements Structuring a requirement Writing pitfalls Traceability Requirements attributes Risks associated to requirements Discussions: Project Life Cycle and Correcting Poorly Written Requirements Workshops: Documenting Requirements and Identify Characteristics of Good Requirements Confirm and Communicate Elicitation Requirements Business analysis communication Requirements communication Communication skills The 7 Cs Timing of communication Planning communication Importance of Collaboration Planning collaboration Documenting communication/collaboration needs Confirming elicitation results Verify requirements Characteristics of good requirements (revisited) Requirements checklist Requirements validation Signing off on requirements Discussions: Responsibility for Communication, Eliciting Communication Needs, Validation Signoff Workshops: Communicating Requirements and Obtaining Signoff Evaluate the Solution Business analyst role in solution evaluation Why solutions under perform What we are looking for in solution evaluation When does solution evaluation occur Performing solution evaluation Planning solution evaluation Metrics that might exist Evaluating long term performance Qualitative vs. quantitative measures Tools & techniques used in solution evaluation Comparing expected to actuals When solution evaluation discovers a variance Tools/techniques for analyzing variances Proposing a recommendation Communicating results of solution evaluation Discussion: Addressing Variance Wrap up and Next Steps Useful books and links on writing effective requirements BABOK© Guide Business Analysis for Practitioners: A Practice Guide Additional course details: Nexus Humans BA04 - Eliciting and Writing Effective Requirements training program is a workshop that presents an invigorating mix of sessions, lessons, and masterclasses meticulously crafted to propel your learning expedition forward. This immersive bootcamp-style experience boasts interactive lectures, hands-on labs, and collaborative hackathons, all strategically designed to fortify fundamental concepts. Guided by seasoned coaches, each session offers priceless insights and practical skills crucial for honing your expertise. Whether you're stepping into the realm of professional skills or a seasoned professional, this comprehensive course ensures you're equipped with the knowledge and prowess necessary for success. While we feel this is the best course for the BA04 - Eliciting and Writing Effective Requirements course and one of our Top 10 we encourage you to read the course outline to make sure it is the right content for you. Additionally, private sessions, closed classes or dedicated events are available both live online and at our training centres in Dublin and London, as well as at your offices anywhere in the UK, Ireland or across EMEA.
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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
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