241 Courses delivered Live Online

The “ISO 27001:2022 Lead Implementer ” course provides comprehensive training in the ISO 27001:2022 standard and all its requirements from the Implementer ’s point of view, as well as basic skills necessary to execute the requirements. It’s a practical-oriented training that should be considered “a must” for every ISO 27001:2022 Implementer. This intensive course is specifically designed to participants to serve as ISO 27001:2022 Lead Implementers.

Data Protection and Clinical Trials

Join our Women in Insurance Leadership Workshop and gain insights from industry experts on how to succeed in the male-dominated insurance sector. This workshop is designed to empower women by providing valuable tools and resources to enhance leadership skills, build professional networks, and create a more inclusive workplace culture. Don't miss this opportunity to connect with other women in the industry and take your career to the next level. Register today!

Course Information This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks. Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings. Is this course for you? Ideal for professionals engaged in GMP across various sectors, including: Research and Development (R&D) Contract Manufacturing Organisations Manufacturing Units Quality Control (QC) Laboratories Auditing Roles. What will you learn? Event objectives - by the end of the course, delegates shall: Have an awareness of the basic requirements of GMP Be aware of UK and EU GMP Rules and Guidance and relevant publications Understand the roles and responsibilities associated with GMP Be able to contribute to and maintain quality documentation Have a basic understanding of product lifecycle and manufacturing Understand the requirements of GMP in the QC laboratory context Have a basic understanding of risk management and mitigation principles Understand the need for quality systems and quality assurance activities Be aware of common regulatory findings. Learning outcomes: delegates will be able to: Implement their role within GMP with confidence and knowledge of the principle requirements Contribute effectively to the GMP quality system and their organisation’s compliance Comprehend where their organisation’s activities sit within the larger GMP arena Know where to seek further information within the published rules and guidance, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 09:30 Introductions and Scope of the Course Understand the group requirements and the tutor's background and experience. 09:45 Background and Regulatory Environment Setting the scene, understanding the context, key legislation. 10:30 Principles of GMP Key points and requirements. 11:15 Break 11:30 Personnel and Responsibilities Management and staff, duties and accountabilities. 12:00 Overview of GMP Manufacturing Basics of the product life cycle. 12:30 Lunch 13:15 Risk Management Workshop Practical exploration of risk and mitigation activities. 14:30 QC Laboratories Activities and practicalities. 15:15 Break 15:30 Compliance Quality Assurance and Self Inspection. 16:15 Question Time A chance for questions on the practicalities of GMP. 16:30 Close of Course Extra Information 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 7 Points   Development Level Learn

Course Information This highly interactive course will provide guidance on why and how to implement a quality system successfully into the research laboratory. By doing so, you will position your innovation for the success it deserves. But leave things as they are and there is a good chance that your science will not realise its full potential should success, and its consequences, come your way. A quality system in your research laboratory is the most effective and efficient way to: Help scientists work more efficiently Ensure discoveries can be defended Protect the value of intellectual property. This course is particularly aimed at those working in early phase research environments which are not constrained by the regulatory requirements of the Good Practice regulations but are producing intellectual property, testing and/or products for the therapeutic market. For organisational reasons, rather than regulatory ones, this is a place where you need to get it right. The programme is delivered by leaders in the field who, quite simply, ‘have done it’. Whether delegates are at senior management level seeking strategic direction, a laboratory head wishing to deliver science that will stand the test of time or a quality professional thrown in at the deep end, this course will provide key insight and practical guidance to underpin future success. Based on risk based systems, tried and tested over many years in the workplace, the programme will help delegates to define, train, implement and monitor the quality of their research, irrespective of field or discipline. Delegates will learn how to help position their organisation for success. Course content: Delegates will be guided thoughtfully through each key component of the process in a stimulating learning environment. The course probes all avenues of the research quality arena, from an initial understanding of the cultural aspects of the scientific discovery environment, to managing quality in outsourced research programmes. Computer systems and e-data security in the research environment will be discussed and pragmatic solutions described to help manage the ballooning cloud of e-data. In addition, the ever blurring boundary between the regulated and non-regulated research environments will be discussed and delegates given perspective on future developments in the field. With this knowledge, delegates will be able to get it ‘right first time’. Is this course for you? The course is designed for all those involved in the research laboratory quality arena and it has been tailored to meet the needs of scientific management, bench scientists and quality professionals alike. Delegates get immediate access to highly experienced tutors who will share their wisdom and insights in an area where few others have been successful. The course is linked with the RQA guidance which builds on years of experience and forms the foundation of the programme. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Sandrine Bongiovanni Associate Director in Research and Quality Compliance, Novartis Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:10 Welcome and Introductions 09:20 History and Overview of the Field Examples of business and regulatory risks and the consequences of low quality in research. A look at the standards and guidelines that exist. 10:00 The Culture, the Politics and the Scientist's Perspective Understanding research environments, the drivers and the challenges. 10:30 Break 10:45 Workshop - Risk Management Thinking about risk management and prioritisation. Looking at the critical factors for the implementations of a successful quality system. 12:15 Workshop - Feedback 12:45 Lunch 13:45 Personnel, Plans, Procedures, Facilities, Equipment, Materials and Reagents Looking at planning the work, defining procedures in a way which promotes robust science without compromising brilliance and ensuring that all these elements are demonstrably fit for their intended purpose. 14:30 Workshop - Assay Validation How much validation is required at what stage? What do we need to validate an assay? 15:00 Workshop - Feedback 15:15 Research, Work Records, Archives and Research Review Data and records which are accurate, attributable, legally attestable and safe to permit reconstruction experiments and studies. Looking at aspects of the work where there is a chance to review, correct or improve the science, the data and the processes. 16:15 Continual Improvement and Quality Systems Reviewing implementation of a quality system, finding opportunities for improvement, understanding culture change. 16:45 Questions and Answers 17:00 Close of Course Extra Information 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 7 Points   Development Level Develop

Course Information This one day course is designed to provide you with comprehensive guidance and practical help for when designing and implementing audit programmes. Using the guidance of ISO 19011 with reference to PV, GCP, GMP and GLP audit programmes, you will explore audit programme design, operation, review and improvement. The course will work through why audits are important and understanding the drivers behind a good audit programme. It will discuss how to identify and assess the risks in your organisation, linking them with organisational goals, using these risks as a basis for the design of a risk-based audit programme during facilitated practical workshops. Delegates will have the opportunity to consider and discuss common issues and constraints that may shape their audit programmes. By the end of the course you will have: A clear understanding of the role of audit programmes in managing compliance and of the drivers and risks behind audit programmes An understanding of the roles and responsibilities of management and personnel An appreciation of resourcing implications and auditor attributes A good insight into the practicalities and activities required for design of risk based audit programmes A comparison of your circumstances, challenges, common issues and ways to approach managing audit programmes with other delegates on the course. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:15 Why do we Need to Audit? Exploring risk and regulation, responsibility and performance. 09:45 Discussion - Programmes, Needs, Commonalities Understanding the needs of delegates' own organisation and comparing common themes and threats. 10:00 Establishing an Audit Programme Design, objectives, risk and resources. This session discusses the consideration when designing audit programmes. 10:30 Break 10:45 Risk Management Considerations, guidance and methods for assessing and controlling risk. 11:00 Workshop 1 - Risks, Prioritisation and Control Looking at specific risks, assessing and evaluating to feed into audit programme management. 12:00 Workshop 1 - Feedback 12:30 Lunch 13:30 Putting it into Practice Resources, practicalities and challenges - the realities of auditing, including selection of auditors, ensuring practice will meet expectations and the reasons to note audit results. 13:45 Workshop 2- Designing Audit Programmes Designing audit programmes using output from risk assessment process. Challenges and flexibility. 15:00 Break 15:15 Workshop 2 - Feedback 15:30 Monitoring, Reviewing and Improving Why or when should existing processes change, understanding the implications of change or inaction and exploring how to improve the audit programme. 16:15 Panel Session This final session will address any outstanding issues raised by delegates. 16:30 Close of Course Extra Information 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 7 Points   Development Level Develop

Learn how to better apply project management techniques to manage small projects as part of your normal role.

Project Management for Non-Project Managers: In-House Training Individuals who are involved in projects (commissioning, supporting, sponsoring, etc.) may often be unfamiliar with project management. A basic understanding of project management is essential for non-project managers, who are critical stakeholders contributing to project success. This awareness course uses A Guide to the Project Management Body of Knowledge (PMBOK® Guide) and other sources to introduce you to project management vocabulary, concepts, and techniques. It also provides insights into the realities of being a project manager, and opportunities to explore how you can positively impact projects in your own role. What You Will Learn At the end of this program, you will be able to: Identify the benefits of project management Use standard project management terminology Describe characteristics of successful projects, project managers, and high-performing teams Explain various project stakeholder roles, their responsibilities, and the fundamental project management processes Recognize how agile / adaptive practices are useful for certain project life cycles Create a personal action plan for how to support real-world projects within a non-PM role Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Project management overview Strategic value of project management Defining project success Project life-cycle models and governance Project roles and responsibilities Project Initiating and Planning Initiating the project Defining project requirements and scope Developing the project schedule and budget Project Risk Management, Executing, Monitoring, and Closing Understanding, evaluating, and adjusting for risk Honoring the baseline and executing the project Monitoring and controlling the project Closing the project Project Interpersonal Processes Project communication Project team development Conflict management

This course is intended for This course is intended for anyone who wants to learn the fundamentals of project management. No prior experience required. Overview Goals and benefits of implementing project management Key project management terminology, frameworks, and tools How to apply the approaches and processes to better manage and complete a project Important interpersonal interactions needed for successful projects This 1-Day virtual Project Management Best-Practices course provides an overview of fundamental elements of the project lifecycle ? from project initiation through project close. With a focus on traditional project management concepts, students will complete this course with an improved ability to understand the best path forward for bringing projects to successful completion. Students will benefit from this course by understanding the foundational principles of project management, improving their project management skills, utilizing tools and techniques to effectively manage projects, gaining a common project management language to improve communication, and learning frameworks to identify, manage, and mitigate risk. Concepts learned in this course are immediately applicable to ongoing projects. Note: This course has been approved by PMI for 8 PDUs. 1 - Introduction What are Projects? What is Project Management? Basic Project Management Process Project Selection How Projects Further Organizational Goals What Factors can Influence Projects? Documentation Project Management Tools Role of the Project Manager The Language of Project Management 2 - Starting a Project Authorizing the Project (Project Selection) Assigning the PM Identifying and Documenting the High-Level Scope Gathering a Planning Team Identifying and Documenting the Impacted Parties 3 - Planning a Project Adapting to the Needs of the Project (Planning Level) Identifying the Work Required Estimating Time, Cost and Resources Required Developing a Schedule Developing a Budget Planning Communications and Quality Risk Management Purchases and Outside Vendors for a Project 4 - Executing the Project Baselines Managing Participants in the Project Managing Interested and Impacted Parties Performing the Planned Work Negotiating and Signing Contracts Managing Communications, Risk and Quality 5 - Overseeing and Controlling the Project Controlling the Scope, Schedule and Budget Controlling Change to the Project (Scope, Schedule, Cost and Final Product) Quality Assurance and Control Contract Administration 6 - Ending a Project Overseeing and Controlling the Project Executing the Project Closing Contracts Transferring the Final Product Lessons Learned and Archiving Records

Project Management for Non-Project Managers (Virtual) Individuals who are involved in projects (commissioning, supporting, sponsoring, etc.) may often be unfamiliar with project management. A basic understanding of project management is essential for non-project managers, who are critical stakeholders contributing to project success. This awareness course usesA Guide to the Project Management Body of Knowledge (PMBOK® Guide) and other sources to introduce you to project management vocabulary, concepts, and techniques. It also provides insights into the realities of being a project manager, and opportunities to explore how you can positively impact projects in your own role. Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Project management overview Strategic value of project management Defining project success Project life-cycle models and governance Project roles and responsibilities Project Initiating and Planning Initiating the project Defining project requirements and scope Developing the project schedule and budget Project Risk Management, Executing, Monitoring, and Closing Understanding, evaluating, and adjusting for risk Honoring the baseline and executing the project Monitoring and controlling the project Closing the project Project Interpersonal Processes Project communication Project team development Conflict management