1361 Objective courses in Sheffield delivered Live Online

Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 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 19 Points Development Level Develop

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Program Management Skills: In-House Training Program managers coordinate and give oversight to the efforts of marketing groups, project teams, product delivery, maintenance and support, operations and staff from various functional groups, including suppliers, business partners, and other external bodies. The goal is to ensure that proposed business transformation, through the delivery of complex products and processes, is implemented to realize the organization's strategic benefits and objectives, for which the program was selected. The goals of this course are twofold: To provide participants with key program management principles and techniques, recognized as best practices, to enable more effective program management; and to leverage core elements of the program management life cycle, processes, tools and techniques, to enable program management effectiveness. The participant will learn and apply the principles of program management through discussions, activities, and case study exercises. What You Will Learn At the end of this workshop, you will be able to: Maximize the transformational impact of a program according to the business needs Explain management principles and techniques and apply them within a program context Implement program governance and organization that will produce expected benefits Plan for and manage benefit realization, risks, issues, and quality Manage component projects' interdependencies that are linked to both program and strategic objectives Engage program stakeholders effectively. Improve communication and action planning effectiveness for programs in organizations Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Fundamental definitions and concepts Program challenges and benefits Program best practices and success criterion Stakeholder management Governance: program management office and program boards Standard for Program Management overview Vision, Leadership, and the Business Case What is vision, why, and how? Leadership vs. Management Program business case Program Organization and Governance Program organization Program governance Program board roles and responsibilities Benefits Management Benefits explored Benefits management Benefits realization Program Management Planning Program management plan Program blueprint and roadmap Program component dossier Program tranches Program estimating Program scheduling Program Monitoring and Controlling Program Control - An Overview Program Monitoring and Controlling Monitoring and Controlling Transition Program Risk and Issue Management Risk and issue management overview Program risk management Program issue management Program Quality Management Program quality management overview Program quality management principles Program Stakeholder Management Stakeholder engagement overview Stakeholder engagement planning EI, trust, communication and stakeholder engagement Program Closure and Benefits Sustainment Program closure overview Closing the program Program benefits sustainment Summary What did we learn, and how can we implement this in our work environments?

SAFe® DevOps: In-House Training This course provides a comprehensive overview for understanding the DevOps skills needed to accelerate time-to-market by improving the flow of value through the Continuous Delivery Pipeline. You will map the current value stream through the delivery pipeline from idea to cash and identify practices that will eliminate bottlenecks to flow. The course will build an understanding of the complete flow of value from Continuous Exploration to Continuous Integration, Continuous Deployment, and Release on Demand. What you will Learn After attending the class, attendees should be able to: Explain how DevOps enables strategic business objectives Apply a CALMR approach to DevOps to avoid automating broken processes Understand how successful DevOps requires continuous exploration, continuous integration, continuous deployment, and the ability to release to end users on demand Incorporate continuous testing and continuous security into the delivery pipeline Use value-stream mapping to measure flow and identify bottlenecks in the end-to-end delivery process Select DevOps skills and tools strategically for the fastest, most compelling results Prioritize DevOps solutions and investments for the greatest economic benefit Design and implement a multi-phased DevOps transformation plan tailored to their organization Work with all roles and levels in the organization to continually optimize the value stream Introducing DevOps Mapping your Continuous Delivery Pipeline Gaining alignment with Continuous Exploration Building quality with Continuous Integration Reducing time-to-market with Continuous Deployment Delivering Business Value with Release on Demand Taking action

  ISO 37001 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining an Anti-bribery Management System (ABMS) based on ISO 37001 About This Course   During this training course, you will also gain a thorough understanding of the global anti-corruption best practices of Anti-bribery Management Systems and effectively prevent, detect and address bribery before it negatively impacts an organization's reputation and profits.   After mastering all the necessary concepts of Anti-bribery Management Systems, you can sit for the exam and gain "Certified ISO 37001 Lead Implementer' credential. By holding this Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 37001 in an organization.   Learning objectives   Acknowledge the correlation between ISO 37001 and other standards and regulatory frameworks Master the concepts, approaches, methods and techniques used for the implementation and effective management of an ABMS Learn how to interpret the ISO 37001 requirements in the specific context of an organization Learn how to support an organization to effectively plan, implement, manage, monitor and maintain an ABMS Acquire the expertise to advise an organization in implementing Anti-bribery Management System best practices   Educational approach   This training is based on both theory and best practices used in the implementation of an ABMS Lecture sessions are illustrated with examples based on case studies Practical exercises are based on a case study which includes role playing and discussions Practice tests are similar to the Certification Exam Prerequisites   A foundational understanding of ISO 37001 and knowledge of implementation principles.  What's Included?   Refreshments & Lunch (Classroom only) Course Slide Deck Official Study Guides CPD Certificate The Exam Accreditation Assessment     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.   Provided by   This course is Accredited by NACS and Administered by the IECB. Who Should Attend?   Professionals looking to implement and maintain an Anti-Bribery Management System Compliance officers

  Delivered in either our Live Online format (4 days) or in our Classroom (5 days), the ISO 37001 Lead Auditor training course enables you to develop the necessary expertise to perform an Anti-bribery Management System (ABMS) audit by applying widely recognized audit principles, procedures and techniques. About This Course   During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.   Based on practical exercises, you will be able to master the audit techniques and become competent to manage an audit program and audit team.    After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain the "Certified ISO 37001 Lead Auditor' credential. By holding this Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.   Learning objectives   Understand the operation of an Anti-bribery Management System based on ISO 37001 and its principal processes Understand the correlation between ISO 37001 and other standards and regulatory frameworks Understand the auditor's role in planning, leading and following-up on a management system audit in accordance with ISO 19011 Interpret the requirements of ISO 37001 in the context of an ABMS audit Strengthen the personal skills necessary for an auditor to act with due professional care during an audit   Educational approach   Lecture sessions are illustrated with practical questions and examples Practical exercises include examples and discussions Practice tests are similar to the certification exam Prerequisites   A foundational understanding of ISO 37001 and knowledge of audit principles. What's Included?   Refreshments & Lunch (Classroom only) Course Slide Deck Official Study Guides CPD Certificate The Exam Who Should Attend?   Auditors seeking to perform and lead Anti-bribery Management System (ABMS) certification audits Managers or consultants seeking to master an Anti-bribery Management System audit process Individuals responsible for maintaining conformance with ISO 37001 requirements Technical experts seeking to prepare for an Anti-bribery Management System audit Expert advisors in Anti-bribery Management Accreditation Assessment   The exam is delivered in a 12 question essay format, to be completed within 150 minutes and gaining a 70% pass mark. Exam results are provided within 24 hours. Provided by   This course is Accredited by NACS and Administered by the IECB.

  After mastering all the necessary concepts of Disaster Recovery processes, you can sit for the exam and gain the "Certified Lead Disaster Recovery Manager' credential. By holding this Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to support and lead Disaster Recovery teams in implementing Disaster Recovery strategies based on best practices.  About This Course   Learning objectives   Acknowledge the correlation between Disaster Recovery, Business Continuity Management, Information Security and other IT areas and frameworks Master the concepts, approaches, methods and techniques used for the implementation and effective management of a Disaster Recovery Plan Learn how to interpret the ICT Disaster Recovery strategies in the specific context of an organization Learn how to support an organization to effectively plan, implement, manage, monitor and maintain DR services based on best practices Acquire the expertise to advise an organization in implementing an effective Disaster Recovery Plan based on best practices   Educational approach   This training is based on both theory and best practices used in the implementation and management of a DR plan Lecture sessions are illustrated with examples based on case studies Practical exercises are based on a case study which includes role playing and discussions Practice tests are similar to the Certification Exam   Course Content   Day 1: Introduction to Disaster Recovery and initiation of a DR plan Day 2: Risk Mitigation Strategies and Disaster Recovery Planning Day 3: Disaster Recovery facilities, services, recovery sites, response and activation Day 4: DRP testing, monitoring, measurement and continuous improvement; the examination Accreditation Prerequisites   A foundational understanding of Disaster Recovery Services and knowledge of management principles, concepts and strategies. Assessment   The exam for this course consists of 12 essay type questions, to be completed within the 150 minute timeframe and achieving the 70% pass mark. Exam results are provided within 24 hours. What's Included?   Certification fees are included on the exam price Training material containing over 450 pages of information and practical examples will be distributed A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued In case of exam failure, you can retake the exam within 12 months for free Provided by   This course is Accredited by NACS and Administered by the IECB. Who Should Attend?   Information Security Managers Incident Managers Helpdesk Managers Executives with Governance concerns  

  ISO 14001 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining an Environmental Management System (EMS) based on ISO 14001. About This Course   During this training course, you will also gain a thorough understanding of the best practices of Environmental Management Systems, consequently reducing an organization's negative environmental impacts and improving its overall performance and efficiency. After mastering all the necessary concepts of Environmental Management Systems, you can sit for the exam and gain "Certified ISO 14001 Lead Implementer' Certification. By holding this Certification, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 14001 in an organization. Learning objectives   Acknowledge the correlation between ISO 14001, ISO 14040 and other standards and regulatory frameworks Master the concepts, approaches, methods and techniques used for the implementation and effective management of an EMS Learn how to interpret the ISO 14001 requirements in the specific context of an organization Learn how to support an organization to effectively plan, implement, manage, monitor and maintain an EMS Acquire the expertise to advise an organization in implementing Environmental Management System best practices Educational approach   This training is based on both theory and best practices used in the implementation of an EMS Lecture sessions are illustrated with examples based on case studies Practical exercises are based on a case study which includes role playing and discussions Practice tests are similar to the Certification Exam Prerequisites   A fundamental understating of ISO 14001 and comprehensive knowledge of implementation principles.  Who Should Attend?   Managers or consultants involved in Environmental Management Expert advisors seeking to master the implementation of an Environmental Management System Individuals responsible for maintaining conformance with EMS requirements EMS team members What's Included?   Refreshments & Lunch (Classroom courses only) Course Slide Deck Official Study Guides CPD Certificate The Exam Accreditation Assessment     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Provided by   This course is Accredited by NACS and Administered by the IECB.

  During this training course, you will also gain a thorough understanding of the best practices of Medical Devices Quality Management Systems and be able to improve an organization`s overall performance by consistently providing safe and qualitative medical devices. After mastering all the necessary concepts of Medical Devices Quality Management Systems, you can sit for the exam and gain the "Certified ISO 13485 Lead Implementer' Certificate. By holding this Certificate, you will be able to demonstrate that you have the practical knowledge and professional capabilities to implement ISO 13485 in an organization.  About This Course   Learning Objectives Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks Master the concepts, approaches, methods and techniques used for the implementation and effective management of a MDQMS Learn how to interpret the ISO 13485 requirements in the specific context of an organization Learn how to support an organization to effectively plan, implement, manage, monitor and maintain a MDQMS Acquire the expertise to advise an organization in implementing Medical Devices Quality Management System best practices   Course Agenda Day 1: Introduction to ISO 13485 and initiation of a MDQMS Day 2: Plan the implementation of a MDQMS Day 3: Implementation of a MDQMS Day 4: MDQMS monitoring, measurement, continuous improvement and preparation for a certification audit, and the final exam. Assessment     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success. Prerequisites   A fundamental understanding of ISO 13485 and comprehensive knowledge of implementation principles. What's Included?   Certification fees are included on the exam price Training material containing over 450 pages of information and practical examples will be distributed An attestation of course completion worth 32 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. In case of exam failure, you can retake the exam within 12 months for free Who Should Attend?   Managers or consultants involved in Medical Devices Quality Management Expert advisors seeking to master the implementation of a Medical Devices Quality Management System Individuals responsible for maintaining conformance with MDQMS requirements MDQMS team members Accreditation Provided by   This course is Accredited by NACS and Administered by the IECB

  ISO 45001 is the first global Occupational Health and Safety Management System standard that replaces OHSAS 18001. The ISO 45001 Lead Implementer training enables you to develop the necessary expertise to support an organization in establishing, implementing, managing and maintaining an Occupational Health and Safety Management System (OH&S MS) based on ISO 45001. About This Course   During this training course, you will also gain a thorough understanding of the best practices of an OH&S MS and be able to apply them to continually improve the organization's OH&S performance and ensure the well-being of employees by providing a safe and healthy workplace.   After mastering all the necessary concepts of Occupational Health and Safety Management Systems, you can sit for the exam and gain the "Certified ISO 45001 Lead Implementer' credential. By holding this Certificate, you will be able to demonstrate that you have the practical skills and professional knowledge to implement ISO 45001 in an organization.   Learning objectives   Acknowledge the correlation between ISO 45001 and other standards and regulatory frameworks Master the concepts, approaches, methods and techniques used for the implementation and effective management of an OH&S management system Learn how to interpret the ISO 45001 requirements in the specific context of an organization Learn how to support an organization to effectively plan, implement, manage, monitor and maintain an OH&S management system Acquire the expertise to advise an organization in implementing OH&S management system best practices   Educational approach   This training is based on both theory and best practices used in the implementation of an OH&S MS Lecture sessions are illustrated with questions and examples that help translate theory into practice Practical exercises include examples and discussions Practice tests are similar to the Certification Exam Prerequisites   A foundational understanding of ISO 45001 and knowledge of implementation principles. Who Should Attend?   Managers or consultants involved and concerned with Occupational Health and Safety Management Expert advisors seeking to master the implementation of an Occupational Health and Safety Management System Individuals responsible for maintaining conformance with OH&S MS requirements OH&S MS team members What's Included?   Refreshments & Lunch * Course Slide Deck Official Study Guides Official Exam Q&A The Exam   * Classroom courses only   Accreditation Assessment   Course delegates will sit a combination of in-course quizzes and exercises, as well as a final 12 question, essay type exam on Day 4 of the course. Overall pass mark is 70%, to be completed within the 150 minute time window. Provided by   This course is Accredited by NACS and Administered by the IECB.