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
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
Internal Quality Assurance of Assessment Processes and Practices (IQA) refers to a systematic and structured approach within educational and training organisations to ensure the quality and consistency of assessment procedures and outcomes. IQA plays a crucial role in maintaining and improving the standards of assessment within various educational settings, such as schools, colleges, vocational training centres, and workplaces. Are you seeking to enhance your expertise in ensuring the quality of assessment processes and practices? The Level 4 Award in the Internal Quality Assurance of Assessment Processes and Practices course is the solution to this educational challenge. This Ofqual-regulated course, awarded by Focus, elevates your educational profile, providing you with the skills to maintain assessment quality standards. Discover how to assess and assure the quality of assessments while gaining a deeper understanding of assessment principles and practices. By completing this course, you'll not only improve your professional knowledge but also open doors to various career opportunities in the education and training sector. Learning Outcomes Evaluate assessment quality principles and practices effectively. Demonstrate competence in internal quality assurance processes. Create comprehensive assessment plans and checklists. Apply observation techniques for quality assurance in assessments. Successfully submit and resubmit course assignments. Why Choose Focus Awards? Choosing Focus Awards for your educational and training programs offers several key advantages. As an Ofqual-governed accrediting body, their qualifications enjoy wide recognition, both nationally and internationally, ensuring you're held to the highest educational standards. Focus Awards' commitment to professionalism, rapid growth, and diverse qualification offerings makes them a dynamic choice for a relevant and exceptional learning experience. Opting for Focus Awards elevates your career prospects, personal development, and educational achievements. Benefits you will gain Benefits you will enjoy include: High-quality virtual learning materials. 24/7 module access. User-friendly online platform. Compliance with standards. Recognised qualification. Exceptional customer service. Guided Learning Hours The Guided Learning Hours for this qualification amount to a total of 90 hours. These hours encompass all instances of learner support, including contact time, guidance, supervision, and instruction provided by qualified educators, trainers, or relevant education and training professionals. Total Qualification Time The Total Qualification Time for this qualification is 120 hours, encompassing both Guided Learning Hours (GLH) and an estimation of the hours a learner is expected to dedicate to self-directed activities, including preparation, study, and assessment, without direct supervision from a lecturer, supervisor, or tutor. Method of Assessment Candidates engage in learner observation and subsequently create IQA reports based on assessor feedback. Candidates are required to submit written assignments, complete with appropriate references, through an online portal. The grading system employs a Pass/Fail approach, contingent upon the fulfilment of all learning objectives. Submissions include learner assessments, two assessor reports, and the candidate's IQA report. Assessors evaluate the candidate's grasp and application of IQA principles. Assignments are assessed based on the application of IQA concepts and the inclusion of reference citations. Progression Upon successful completion of a Level 4 Internal Quality Assurance (IQA) course, learners can advance their expertise by pursuing further education and qualifications in the education and quality assurance field. Here's a list of potential courses and qualifications for consideration: Level 5 Diploma in Education and Training (DET): Enables individuals to qualify as educators in the further education and training sector. Level 5 Certificate in Leadership and Management: Develops leadership and management skills tailored for the education sector. Level 5 Diploma in Education and Training (Education and Training Pathway): Offers specialised training in delivery, assessment, and quality assurance. Level 3 Certificate in Assessing Vocational Achievement (CAVA): Focuses on assessing vocational qualifications. Level 4 Award in Understanding External Quality Assurance: Preps individuals for roles in external quality assurance. Level 5 Certificate in Education and Training (In-Service Route): Designed for experienced educators seeking specialised routes. Master's Degree in Education or Quality Assurance: Offers advanced educational and research opportunities. Specialised Short Courses: Targeted workshops addressing specific areas within education. Continuous Professional Development (CPD): Ongoing learning through participation in workshops and conferences. Professional Memberships and Certifications: Opportunities to join relevant organisations and obtain certifications. Qualification Purpose The main goal of the Level 4 Award in Internal Quality Assurance of Assessment Processes and Practices (RQF) is to confirm competence in a specific occupational role in accordance with relevant standards. This qualification is designed for individuals who are entrusted with the duty of maintaining and improving the quality of assessments within an organization or assessment center. Who is this course for? Education professionals aspiring to enhance assessment quality. Assessors looking to improve their internal quality assurance skills. Individuals pursuing a career in assessment and quality assurance. Those seeking to comply with UK Government regulations in education. Requirements This qualification is open to all learners aged 16 and above, including those aged 19 and older, and it does not have any mandatory prerequisites. While it doesn't require specific educational backgrounds, some learners may have completed at least high school or possess Level 3 qualifications in AET (Assessing and Evaluating Training) and CAVA (Certificate in Assessing Vocational Achievement). Career path Internal Quality Assurer: £24,000 - £35,000 per year Education Consultant: £30,000 - £50,000 per year Training Manager: £30,000 - £45,000 per year Curriculum Developer: £25,000 - £40,000 per year Further Education Lecturer: £25,000 - £40,000 per year Quality Assurance Manager: £30,000 - £50,000 per year Note: There is No Registration, Assessment, Certification fee included with this price.
Level 5 QLS Endorsed Course | Endorsed Certificate Included | Plus 5 Career Guided Courses | CPD Accredited
Get to enter the field of education and training with the most in-demand skill set! The Level 3 Award in Education and Training (RQF) qualification will be your surefire way to achieve more incredible things in your professional life. Level 3 Award in Education and Training (RQF) qualification has all the extensive and all-embracing resources developed by industry experts and education enthusiasts. It will introduce you to various essential teaching topics, allowing you to begin building a successful teaching career. Furthermore, you will gain a globally recognised certificate that will add immense value to your personal and professional growth. The Level 3 Award in Education and Training (RQF) is a level 3 Award in Education and Training AET (previously PTLLS) that has been regulated by the UK government and granted by Focus, the UK's fastest-growing awarding organisation. Focus is a well-known awarding body controlled by Ofqual, ensuring professionalism and respect for the qualifications. Enrol today and grab this once-in-a-lifetime opportunity. Qualification Summary Qualification type: Focus Level 3 Award Qualification title: Focus Level 3 Award in Education and Training (RQF) Accreditation status: Accredited Level: 3 Guided Learning Hours (GLH): 48 Total Qualification Time (TQT): 120 Qualification number (QN): 601/6099/8 ****Qualification Curriculum**** **Level 3 Award in Education and Training (RQF)** Unit 1: Understanding Roles, Responsibilities and Relationships in Education and Training Unit 2: Understanding and Using Inclusive Teaching and Learning Approaches in Education and Training Unit 5: Understanding Assessment in Education and Training Course Duration Total Qualification Time This is an estimate of the total length of time it is expected that a learner will typically take to achieve and demonstrate the level of attainment necessary for the award of the qualification i.e. to achieve all learning outcomes. Total Qualification Time is GLH and an estimate of the number of hours a learner is likely to spend in preparation, study, or any other learning including assessment, which takes place as directed by, but not under the supervision of a lecturer, supervisor, or tutor. The credit value, where given, for qualification, is determined by TQT, as one credit corresponds to 10 hours of learning. Total Qualification Time for this qualification is 120 hours. Guided Learning Hours These hours are made up of all contact time, guidance, or supervision of a learner by a lecturer, supervisor, tutor, trainer, or other appropriate provider of education or training. Guided Learning Hours for this qualification is 48. Assessment Unit 1: Understanding Education and Training Roles, Responsibilities, and Relationships You will be required to submit a written assignment that demonstrates your understanding of legal duties, equality and diversity, individual learning requirements, keeping a safe and helpful learning environment, and your position as a teacher and superior. Unit 2: Using and understanding comprehensive teaching and learning strategies in the classroom You must provide a written assignment that demonstrates your knowledge and comprehension of inclusive teaching and learning, as well as your grasp of your own role's strengths and limitations, how to inspire learners, ground rules, and teaching and learning resources. You'll need to do a 15-minute to one-hour micro-teach (which will be filmed and uploaded to your online learning account) teaching a session of your choosing to a group of at least three people. Unit 5 - Education and Training Assessment You will be required to submit a written assignment demonstrating your awareness of the goal of assessment, different assessment kinds, how to conduct assessments, understanding learner involvement in assessment, reasons for constructive feedback, and good assessment recording keeping. Video Assessment You have to plan many things, such as observation, questioning/ professional discussion, and inspection of supporting work product evidence. Detailed assignment instructions will be made available to you in the 'Guidance for Achieving the Unit' section of your learning portal with a careful and clear explanation. You have to submit all your assignments via the online portal. Certification Successful candidates will be awarded a Level 3 Award in Education and Training (RQF) from Focus Awards Limited. Progression Level 4 Certificate in Education and Training Level 5 Diploma in Education and Training Level 3 Award in Understanding the Principles and Practices of Assessment Level 3 Award in Assessing Competence in the Work Environment Level 3 Award in Assessing Vocational Related Achievement Level 3 Certificate in Assessing Vocational Achievement Level 4 Award in Understanding the Internal Quality Assurance of Assessment Processes and Practice Level 4 Award in the Internal Quality Assurance of Assessment Processes and Practice Level 4 Certificate in Leading the Internal Quality Assurance of Assessment Processes and Practice Level 4 Award in Learning and Development Level 4 Diploma in Learning and Development Who is this course for? Those who have already worked in the teaching profession The aspiring professionals who want to add new skills to their CV Individuals who want to start their career as a teaching assistant Requirements Level 3 Award in Education & Training (RQF) qualification does not have any specific entry requirements for students. However, you must be at least 19 years old or above to register and undergo an initial assessment. Career path Level 3 Award in Education & Training (RQF) You will have the ability to accomplish a lot of things with this certificate. Here are just a few examples: Primary School Teacher Secondary School Teacher Private Tutor Freelance Teacher/ Trainer Consultant Job hunters & School leavers Educational Psychologist Office clerk & Administration Assistant College or University Student
24 Hour Flash Deal **25-in-1 Advanced Quality Control Technician Diploma Mega Bundle** Advanced Quality Control Technician Diploma Enrolment Gifts **FREE PDF Certificate**FREE PDF Transcript ** FREE Exam** FREE Student ID ** Lifetime Access **FREE Enrolment Letter ** Take the initial steps toward a successful long-term career by studying the Advanced Quality Control Technician Diploma package online with Studyhub through our online learning platform. The Advanced Quality Control Technician Diploma bundle can help you improve your CV, wow potential employers, and differentiate yourself from the mass. This Advanced Quality Control Technician Diploma course provides complete 360-degree training on Advanced Quality Control Technician Diploma. You'll get not one, not two, not three, but twenty-five Advanced Quality Control Technician Diploma courses included in this course. Plus Studyhub's signature Forever Access is given as always, meaning these Advanced Quality Control Technician Diploma courses are yours for as long as you want them once you enrol in this course This Advanced Quality Control Technician Diploma Bundle consists the following career oriented courses: Course 01: Quality Manager Course 02: Six Sigma Green Belt Diploma Course 03: ISO 9001:2015 Course 04: RCA: Root Cause Analysis Course 05: Quality Assurance Manager Course 06: The 5S Lean Methodology in Action Course 07: Lean Organisation Management Principles, Process and Techniques Course 08: Risk Management Course 09: Managing Quality and Service Delivery Course 10: Internal Audit and Risk Control Training Course 11: Product Testing Protocols for Quality Assurance Course 12: Strategic Planning and Implementation Course 13: Project, Change, and Quality Management Course 14: Process Mapping Course 15: Process Improvement Course 16: Managing Change and Continual Improvement Course 17: Procurement, Logistic and Quality Management Course 18: Adult Care Management: Providing Quality Care for Adults in Need Course 19: Environmental Management Course 20: Occupational Safety and Incident Management Course 21: Good Manufacturing Practices (GMP) Certification Course 22: Product Management Course 23: Project Management Course 24: Six Sigma Black Belt - Advance Diploma Course 25: Web Application Penetration Testing The Advanced Quality Control Technician Diploma course has been prepared by focusing largely on Advanced Quality Control Technician Diploma career readiness. It has been designed by our Advanced Quality Control Technician Diploma specialists in a manner that you will be likely to find yourself head and shoulders above the others. For better learning, one to one assistance will also be provided if it's required by any learners. The Advanced Quality Control Technician Diploma Bundle is one of the most prestigious training offered at StudyHub and is highly valued by employers for good reason. This Advanced Quality Control Technician Diploma bundle course has been created with twenty-five premium courses to provide our learners with the best learning experience possible to increase their understanding of their chosen field. This Advanced Quality Control Technician Diploma Course, like every one of Study Hub's courses, is meticulously developed and well researched. Every one of the topics is divided into Advanced Quality Control Technician Diploma Elementary modules, allowing our students to grasp each lesson quickly. The Advanced Quality Control Technician Diploma course is self-paced and can be taken from the comfort of your home, office, or on the go! With our Student ID card you will get discounts on things like music, food, travel and clothes etc. In this exclusive Advanced Quality Control Technician Diploma bundle, you really hit the jackpot. Here's what you get: Step by step Advanced Quality Control Technician Diploma lessons One to one assistance from Advanced Quality Control Technician Diplomaprofessionals if you need it Innovative exams to test your knowledge after the Advanced Quality Control Technician Diplomacourse 24/7 customer support should you encounter any hiccups Top-class learning portal Unlimited lifetime access to all twenty-five Advanced Quality Control Technician Diploma courses Digital Certificate, Transcript and student ID are all included in the price PDF certificate immediately after passing Original copies of your Advanced Quality Control Technician Diploma certificate and transcript on the next working day Easily learn the Advanced Quality Control Technician Diploma skills and knowledge you want from the comfort of your home CPD 250 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Advanced Quality Control Technician Diploma training is suitable for - Students Recent graduates Job Seekers Individuals who are already employed in the relevant sectors and wish to enhance their knowledge and expertise in Advanced Quality Control Technician Diploma American Society for Quality Quality Assurance Agency Chartered Quality Institute Requirements To participate in this Advanced Quality Control Technician Diploma course, all you need is - A smart device A secure internet connection And a keen interest in Advanced Quality Control Technician Diploma Career path You will be able to kickstart your Advanced Quality Control Technician Diploma career because this course includes various courses as a bonus. This Advanced Quality Control Technician Diploma is an excellent opportunity for you to learn multiple skills from the convenience of your own home and explore Advanced Quality Control Technician Diploma career opportunities. Certificates CPD Accredited Certificate Digital certificate - Included CPD Accredited e-Certificate - Free CPD Accredited Hardcopy Certificate - Free Enrolment Letter - Free Student ID Card - Free
3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 10 CPD Courses | Lifetime Access
Level 3 Award in Assessing Competence in the Work Environment Course was known as A1 course. Learn More Academy provides Assessor distance learning or classroom based course in different locations in the UK. Level 3 Assessing Competence in the Work Environment is for practitioners who assess the demonstration of competence in a work environment using the following assessment methods: observation/examining work products/oral questioning and discussion/use of witnesses/learner statements/Recognition of Prior Learning (RPL). ABOUT THIS COURSE: Assessing Competence in the Work Environment is for practitioners who assess the demonstration of competence in a work environment using the following assessment methods: observation/examining work products/oral questioning and discussion/use of witnesses/learner statements/Recognition of Prior Learning (RPL). UNIT COVERED: Level 3 Award in Assessing Competence in the Work Environment (Assessor) course consists of the following 2 Units: Unit 1: Understanding the principles and practices of assessment D/601/5313 Unit 2: Assess occupational competence in the work environment H/601/5314 COURSE OUTLINE: • Understand the principles and requirements of assessment • Understand how to involve learners and others in assessment • Understand different types of assessment method • Understand the legal and good practice requirements in relation to assessment • Be able to plan the assessment of occupational competence • Understand how to plan assessment • Understand how to make assessment decisions • Be able to make assessment decisions about occupational competence • Be able to provide required information following the assessment of occupational competence • Understand quality assurance of the assessment process • Understand how to manage information relating to assessment • Be able to maintain legal and good practice requirements when assessing occupational competence ENTRY REQUIREMENT: There are no formal requirements for this course, however, candidates should be working in, or working towards a role in quality assurance. However to undertake the full Award candidates are required to have access to two learners. COURSE ASSESSMENT: No closed book exam is required and there is no formal examination is required, however at the end of the course you need to submit a portfolio assignment with related documents. WHY YOU CHOOSE US: • Qualified and long experienced trainers. • Recognised Training Provider. • Tutors support available. • 99% pass rate. • Very reasonable course fees. • No hidden cost/fees. • Quick result and certificates . • We have dedicated team to support you. • Career advise available if needed. HOW MUCH THIS COURSE COST? Level 3 Award in Assessing Competence in the Work Environment (TAQA) course will cost for Online Distance Learning £309.99 and for Webinar Classroom based course £429.99 There is no any hidden fess/cost.
Level 3 Award in Education and Training: Elevate your career as a certified educator! Gain essential teaching skills, curriculum expertise, and effective classroom management. Flexible study options with ongoing support. Enrol now to advance your teaching journey