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  ISO 13485 Foundation training enables you to learn the basic elements to implement and manage a Medical Devices Quality Management System (MDQMS) as specified in ISO 13485. During this training course, you will be able to understand the different modules of a MDQMS, including MDQMS policy, procedures, performance measurements, management commitment, internal audit, management review and continual improvement. After completing this course, you can sit for the exam and gain "Certified ISO 13485 Foundation' Certification. This Certificate shows that you have understood the fundamental methodologies, requirements, framework and management approach.  About This Course   Learning Objectives Understand the elements and operations of a Medical Devices Quality Management System (MDQMS) Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks Understand the approaches, methods and techniques used for the implementation and management of a MDQMS   Course Agenda Day 1: Introduction to Medical Devices Quality Management System (MDQMS) concepts as required by ISO 13485 Day 2: Medical Devices Quality Management System requirements and Certification Exam   Assessment     Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final 40 question, multiple choice exam on Day 2 of the course. The overall passing score is 70%, to be achieved within the 60 minute time allowance. Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.   Prerequisites   None What's Included?   Certification fees are included on the exam price Training material containing over 200 pages of information and practical examples will be distributed An attestation of course completion worth 14 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course. Who Should Attend?   Individuals involved in Medical Devices Quality Management Individuals seeking to gain knowledge about the main processes of Medical Devices Quality Management Systems (MDQMS) Individuals interested to pursue a career in Medical Devices Quality Management Accreditation Provided by   This course is Accredited by NACS and Administered by the IECB

Business Relationship Management Fundamentals: In-House Training Business Relationship Management (BRM) Fundamentals introduces BRM as a capability, role, and discipline. What you will Learn Participants can expect an interactive and lively one-day session, with a high-level introduction to successfully navigate the complexity of BRM. Topics include: Defining BRM as a capability, role, and discipline Understanding what a BRM does and does not do Providing the language needed to change perceptions and perspectives Learn how the BRM discipline interacts with other disciplines (project management, architecture, Business Analysts, Business functions, strategy, etc.) inside an organization Basic introduction to the different frameworks, processes, and models to bring structure and guidance to BRM Introductions Why BRM? BRM defined BRM in action BRM value Reflection and next steps Resources

Business Relationship Management Fundamentals Business Relationship Management (BRM) Fundamentals introduces BRM as a capability, role, and discipline. What you will Learn Participants can expect an interactive and lively one-day session, with a high-level introduction to successfully navigate the complexity of BRM. Topics include: Defining BRM as a capability, role, and discipline Understanding what a BRM does and does not do Providing the language needed to change perceptions and perspectives Learn how the BRM discipline interacts with other disciplines (project management, architecture, Business Analysts, Business functions, strategy, etc.) inside an organization Basic introduction to the different frameworks, processes, and models to bring structure and guidance to BRM Introductions Why BRM? BRM defined BRM in action BRM value Reflection and next steps Resources

Overview This one day course is designed for anyone that deals with telephone sales in either an inbound or outbound call environment. Description The telephone has become a critical tool in obtaining sales in today’s competitive market, and yet it is often an area we pay little attention to, and consequently it becomes a negative aspect of our business rather than the highly positive one it can be. This course sets out to enable the attendees to sell effectively over the phone. The tools that are covered will help generate sales and whether they take inbound or receive outbound calls they will find that if they apply the techniques in this session, their success rate will increase immensely. Topics covered: Advantages and Disadvantages – A look at how the phone can work for and against us in a sales environment. An Introduction to Selling on the Telephone – Understanding the key points that encourage a customer to purchase from us. Structuring and the Sales Process – Defining a set process for structuring a sales call with a chance to demonstrate understanding. Why People Buy – A look at the reasoning behind people’s purchasing decisions. How People Buy – An insight into the emotional factors behind how people arrive at purchasing decisions. Turning Inbound Calls into Sales – Gauging the level of interest of a caller in order to establish the likelihood of a sale. Making Effective Outbound Calls – A set process of ensuring you gain the best advantage with this type of call. Getting Past the Gatekeeper – Understanding the role of the gatekeeper and developing methods of dealing with them in order to speak to the decision maker. Using scripts and techniques that are proven and effective. Sounds Interesting? – Studying three key communication factors when projecting the voice over the phone. Including a chance to review how the participant’s voice comes across over the phone. Methods of Improving the Way You Sound – 10 key tips on vocal improvement. Telephone Questioning Techniques – Giving the delegates the chance to fully understand the different questioning techniques that can be used during a sales call. Features and Benefits – How to practically apply them in a sales scenario. Logical and Emotional Purchasing – A further look at the reasons we buy. Overcoming Objections – Practical use of a set process and ways to apply it in the workplace. Closing the Sale – Clear methodology with a chance to practice the skills in a fun way. Post-course Assignment – A method of carrying the learning into the workplace and ensure continual review. Who should attend the course? Anyone who handles inbound or outbound sales calls over the telephone. Requirements for Attendance No prerequisites required.

The course will be delivered through 9 online virtual classroom sessions. The 10th and last session will involve the additional practical work for the course as well as the written examination (multiple choice for City & Guilds and written for Hi-Tech Training) which will take place at our training centre at 43 North Great Georges Street, Dublin 1 (completed online for non ROI learners). During the virtual classroom sessions, trainees will have a live video feed with their instructor talking to them, doing practical live demonstrations on equipment being involved actively in the learning. We will send out a practical kit so that trainees can complete assignments and practical work at home. The kit is the property of Hi-Tech Training and will be returned to Hi-Tech Training on the last day of the course. (The kits may also be purchased by the learner….see the Kits Page Link for more details). The kit consists of power supply unit breadboard, multimeter, cables, The kit consists of breadboard, multimeter, oscilloscope, battery and connectors, components including resistors, LEDs and ICs (AND, NAND, OR, NOR, X-OR, X-NOR, Inverter, Buffer, Latches, Flip-Flops, Timers, etc). Trainees will build various projects as part of the course. The kit forms an integral part of the course, so full course fees need to be paid at least 7 days prior to course commencement to allow time to ship the kit in time for the course.

Overview This one day Building Better Work Habits training course has been developed for everyone in your organisation who may struggle with their own personal effectiveness. They may not have control of their own workload or blame others as to why they’re not achieving certain tasks and projects. Alternatively, it might be that high performers want to understand how they can organise themselves in a new way to give themselves more stretch in their roles. The training course will help the learners build self-awareness and will highlight the important parts of working smarter to achieve end goals. Description We are all busy, and sometimes it seems we do not have enough hours in the day to complete deadlines and projects. It can then eat into our home life, meaning we often end up stressed, or in worst-case scenarios, unwell (both physically and mentally). The reason behind this is often how we work day to day, as opposed to others giving us work at the last minute. These training course materials have been designed to help your participants work more effectively for the long term. This isn’t about how to manage a diary or emails, but rather look closely to see what are the blockers which get in the way of success. These small changes in day to day work will have a dramatic impact in both productivity and personal effectiveness. Topics covered: Productivity: the science bit – A chance to explore what we mean by being productive and how that helps us build better work habits, as well as the opportunity to look at some of the science behind myths and bad habits we’ve probably already formed. Includes a link to a YouTube video. Procrastination, why put off to tomorrow what we can do today! – Participants will explore what we procrastinate about, how we procrastinate in our own lives, and what we can do about it! Eat That Frog – An introduction to Brian Tracy’s book “Eat that frog” and how it can help us improve our working habits. Includes a link to a YouTube video. Eat That Frog: Thinking on Paper – A chance to put into practice some of Brian Tracy’s methods and how to use them in our real lives Eat That Frog: Rocks, Pebbles and Sand – Taking our goal setting further, we explore Covey’s methodology around prioritising our tasks. Eat That Frog: The Pareto Principle – The final part of the “Eat that Frog” section looks at how effective we in terms of how we spend our day Prioritising: how do we spend our day? – Participants explore how proactive they are, and what the danger might be in letting a situation rule their time Prioritising: The Priority Matrix – Taking the Rock, Pebbles and Sand methodology further, participants explore what truly is urgent and what is important in our day to day Prioritising: Company Performance Tensions – We may know what our own personal objectives are, however, our business objectives have certain tensions that could impact these. How can we balance these two different objectives to ensure we’re successful day to day? What’s my mindset? – Sometimes we can get in the way of our own successes and plans due to our mindset; utilising Carol Dweck’s work, it is a chance to reflect on our own mindsets when we’re building new work habits. Includes a link to a YouTube video. What’s my mindset? Energy Cycles – Our energy can impact our mindset and how productive we are. A chance to look at what gives us energy, and how we can work more effectively depending on where our energy levels might be Who should attend Anyone interested in understanding in being more effective at work. Requirements for Attendees None.

Overview This one day Building Better Work Habits training course has been developed for everyone in your organisation who may struggle with their own personal effectiveness. They may not have control of their own workload or blame others as to why they’re not achieving certain tasks and projects. Alternatively, it might be that high performers want to understand how they can organise themselves in a new way to give themselves more stretch in their roles. The training course will help the learners build self-awareness and will highlight the important parts of working smarter to achieve end goals. Description We are all busy, and sometimes it seems we do not have enough hours in the day to complete deadlines and projects. It can then eat into our home life, meaning we often end up stressed, or in worst-case scenarios, unwell (both physically and mentally). The reason behind this is often how we work day to day, as opposed to others giving us work at the last minute. These training course materials have been designed to help your participants work more effectively for the long term. This isn’t about how to manage a diary or emails, but rather look closely to see what are the blockers which get in the way of success. These small changes in day to day work will have a dramatic impact in both productivity and personal effectiveness. Topics covered: Productivity: the science bit – A chance to explore what we mean by being productive and how that helps us build better work habits, as well as the opportunity to look at some of the science behind myths and bad habits we’ve probably already formed. Includes a link to a YouTube video. Procrastination, why put off to tomorrow what we can do today! – Participants will explore what we procrastinate about, how we procrastinate in our own lives, and what we can do about it! Eat That Frog – An introduction to Brian Tracy’s book “Eat that frog” and how it can help us improve our working habits. Includes a link to a YouTube video. Eat That Frog: Thinking on Paper – A chance to put into practice some of Brian Tracy’s methods and how to use them in our real lives Eat That Frog: Rocks, Pebbles and Sand – Taking our goal setting further, we explore Covey’s methodology around prioritising our tasks. Eat That Frog: The Pareto Principle – The final part of the “Eat that Frog” section looks at how effective we in terms of how we spend our day Prioritising: how do we spend our day? – Participants explore how proactive they are, and what the danger might be in letting a situation rule their time Prioritising: The Priority Matrix – Taking the Rock, Pebbles and Sand methodology further, participants explore what truly is urgent and what is important in our day to day Prioritising: Company Performance Tensions – We may know what our own personal objectives are, however, our business objectives have certain tensions that could impact these. How can we balance these two different objectives to ensure we’re successful day to day? What’s my mindset? – Sometimes we can get in the way of our own successes and plans due to our mindset; utilising Carol Dweck’s work, it is a chance to reflect on our own mindsets when we’re building new work habits. Includes a link to a YouTube video. What’s my mindset? Energy Cycles – Our energy can impact our mindset and how productive we are. A chance to look at what gives us energy, and how we can work more effectively depending on where our energy levels might be Who should attend Anyone interested in understanding in being more effective at work. Requirements for Attendees None.

Course Overview: Introduction to COPD in Primary CareThese introductory days are tailored for nurses and other healthcare professionals who are new to the realm of COPD care or have not received formal training in this area. Led by Paula Matson, a Respiratory Specialist and Practice Nurse, the program is designed to build a foundational understanding of COPD and empower participants to provide effective care to COPD patients in primary care settings.These introductory sessions offer a comprehensive journey from the fundamentals of COPD understanding to a confident approach in patient review and management, emphasizing the importance of early intervention and holistic care in primary care settings. Learning Outcomes: Upon completion of this Introduction to COPD course, participants will attain the following learning outcomes: 1. Emphasize Early Prevention: Recognize the significance of early prevention in COPD management and its impact on patient outcomes. 2. Grasp COPD Physiology: Develop a foundational understanding of the physiological underpinnings of COPD, aiding accurate assessment and care. 3. Comprehend Medications and Roles: Acquire knowledge about COPD medications, comprehending their diverse roles in managing symptoms. 4. Non-Pharmacological Management: Understand and appreciate non-pharmacological approaches to COPD care and symptom management. 5. Inhaler Proficiency: Gain expertise in managing various types of inhaler devices, ensuring effective medication delivery. 6. Documentation Proficiency: Understand the importance of meticulous documentation, including utilizing templates for streamlined care. 7. Review and Self-Management: Realize the value of regular patient review and supervised self-management plans for COPD patients. 8. Problem Solving and Solutions: Foster discussions to address relevant practice issues and collaboratively discover effective solutions. 9. Commitment to Ongoing Development: Recognize the importance of continuous professional development in the evolving landscape of COPD care These introductory sessions offer a comprehensive journey from the fundamentals of COPD understanding to a confident approach in patient review and management, emphasizing the importance of early intervention and holistic care in primary care settings.

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