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Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 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 14 Points Development Level Develop

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Do you want to prepare for your dream job but strive hard to find the right courses? Then, stop worrying, for our strategically modified Technical Report Writing bundle will keep you up to date with the relevant knowledge and most recent matters of this emerging field. So, invest your money and effort in our 40 course mega bundle that will exceed your expectations within your budget. The Technical Report Writing related fields are thriving across the UK, and recruiters are hiring the most knowledgeable and proficient candidates. It's a demanding field with magnitudes of lucrative choices. If you need more guidance to specialise in this area and need help knowing where to start, then StudyHub proposes a preparatory bundle. This comprehensive Technical Report Writing bundle will help you build a solid foundation to become a proficient worker in the sector. This Technical Report Writing Bundle consists of the following 30 CPD Accredited Premium courses - Course 1: Write and Publish a Research Paper: Complete Guide v6 Course 2: How to Write a Research Paper in Law and Humanities Course 3: Creative Writing Course 4: Copywriting Course Level 4 Course 5: Novel Writing and Publishing Course 6: News Writing: Journalism 101 Course 7: Blogger for Beginners Course 8: Medieval History Course 9: Military History Course 10: The History of the Industrial Revolution in Great Britain Course 11: Creative Writing Course: Writing Storybooks For Children Course 12: Diploma in Drama and Comedy Writing Course 13: Creative Writing Course - Short Stories Course 14: Creative Writing Course - Fiction Course 15: Creative Writing Course - Horror Course 16: Creative Writing Course - Novel Course 17: Creative Writing Course - Thriller Course 18: Creative Nonfiction Book Writing Course 19: Selling E-books: The Best Way of Earning Online Course 20: Business Writing Course 21: Business Writing - How You Can Become a Great Writer Course 22: Business Writing: Influence Your Readers Course 23: Freelance Masterclass - Become An Expert Copywriter Course 24: Content Writing & Copy Writing For SEO and Sales Course 25: Email Writing Training Course 26: English: Spelling, Punctuation, and Grammar Course 27: Creative Advertising and Graphic Design for Everyone Course 28: CV Writing and Job Searching Course 29: Foundations of Leadership and Negotiation Skills Development Course 30: Personal Development and Productivity Level 2 10 Extraordinary Career Oriented courses that will assist you in reimagining your thriving techniques- Course 1: Career Development Plan Fundamentals Course 2: CV Writing and Job Searching Course 3: Interview Skills: Ace the Interview Course 4: Video Job Interview for Job Seekers Course 5: Create a Professional LinkedIn Profile Course 6: Business English Perfection Course Course 7: Networking Skills for Personal Success Course 8: Boost Your Confidence and Self-Esteem Course 9: Public Speaking Training Course 10: Learn to Fight Procrastination Learning Outcome This tailor-made Technical Report Writing bundle will allow you to- Uncover your skills and aptitudes to break new ground in the related fields Deep dive into the fundamental knowledge Acquire some hard and soft skills in this area Gain some transferable skills to elevate your performance Maintain good report with your clients and staff Gain necessary office skills and be tech savvy utilising relevant software Keep records of your work and make a report Know the regulations around this area Reinforce your career with specific knowledge of this field Know your legal and ethical responsibility as a professional in the related field This Technical Report Writing Bundle resources were created with the help of industry experts, and all subject-related information is kept updated on a regular basis to avoid learners from falling behind on the latest developments. Certification After studying the complete training you will be able to take the assessment. After successfully passing the assessment you will be able to claim all courses pdf certificates and 1 hardcopy certificate for the Title Course completely free. Other Hard Copy certificates need to be ordered at an additional cost of •8. CPD 400 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Ambitious learners who want to strengthen their CV for their desired job should take advantage of the Technical Report Writing bundle! This bundle is also ideal for professionals looking for career advancement. Requirements To participate in this course, all you need is - A smart device A secure internet connection And a keen interest in Technical Report Writing Career path Upon completing this essential Bundle, you will discover a new world of endless possibilities. These courses will help you to get a cut above the rest and allow you to be more efficient in the relevant fields.

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ICA Advanced Certificate in Business Compliance The ICA Advanced Certificate in Business Compliance has been specifically designed for those working outside financial services. The need for guidance and training in meeting regulatory requirements extends to many industry sectors including oil and gas, aerospace, pharmaceuticals, telecoms, and manufacturing. This course will enable practitioners working in areas such as these to gain knowledge of the essentials of compliance in a practical business context as well as understand the roles of both the compliance function and compliance professionals. The Advanced Certificate will develop the compliance/risk management knowledge and skills of individuals and thereby help to enhance the overall reputation and performance of their firms. Benefits of studying with ICA: Flexible learning solutions that are suited to you Our learner-centric approach means that you will gain relevant practical and academic skills and knowledge that can be used in your current role Improve your career options by undertaking a globally recognised qualification that hiring managers look for as part of their hiring criteria Many students have stated that they have received a promotion and/or pay rise as a direct result of gaining their qualification The qualifications ensure that you are enabled to develop strategies to help manage and prevent risk within your firm, thus making you an invaluable asset within the current climate Upon successful completion of this course, students will be awarded the ICA Advanced Certificate in Business Compliance and will be able to use the designation - Adv.Cert(Bus.Comp). This qualification is awarded in association with Alliance Manchester Business School, the University of Manchester. What will you learn? The context of compliance and its origins Building an effective control framework The skills needed to be an effective compliance professional Risk management, alert systems and investigations Managing financial crime risk Creating competitive advantage How will you be assessed? Assessed by a one-hour, question-based exam and one research-based assignment

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DESIGN AND MOCK UP BAGS AND ACCESSORIES – LEARN HOW TO PLAN, DESIGN AND COMMUNICATE YOUR PROJECT – Group Class: one teacher, six students – You will learn: What you need to study, research, and understand about the industry.How to correctly design a collection of fashion accessories.What information you should be able to provide about your designs.How to prepare a project for prototyping and manufacturing. How to create three-dimensional mock-ups of your designs. WHERE:At our South East London studioCOURSE LENGTH:Two consecutive weeks / Mon-Fri 10 am-3.30 pm   LEVEL:Complete beginners, beginners with some experience of drawing and/or designing and intermediate designers COURSE DESCRIPTION: BAG AND ACCESSORY DESIGN MASTERCLASSThis course is tailored for beginners and intermediate-level participants, offering a distinctive group class format designed to assist aspiring designers or those seeking guidance in bringing to life a practical and viable collection of bags and/or accessories.Through this course, you will gain a comprehensive grasp of fundamental skills in accessory design and what it requires to become a bag designer. It empowers you to transform your creative concepts into tangible realities by providing instruction on the essential steps required for prototyping and manufacturing your collection.In addition to acquiring the skills to design bags and accessories accurately and understanding what information to convey to a prototype maker, this course will guide you through the process of constructing three-dimensional mock-ups for your designs.   WHY THIS COURSE DIFFERS FROM THE TYPICAL ‘ACCESSORY DESIGN’ PROGRAMMEThis course has been meticulously designed by a team comprising designers, prototype makers, and handbag manufacturers. It offers a blend of theoretical and practical elements, providing you with the knowledge required by the industry to comprehend and accurately translate your ideas into finished products.Unlike courses that solely focus on creating aesthetically pleasing drawings, this programme emphasizes providing a comprehensive understanding of the intricate and extensive processes involved in designing a collection of handbags. It aims to equip you with the insights necessary to navigate the complexities, ensuring you are well-prepared before and during the design phase. By doing so, the course aims to save you time, expense, and potential frustration when it comes to prototyping and manufacturing your collection.   WHY WE DEVELOPED A FASHION DESIGN COURSEAfter years of designing and developing collections for our clients, we noticed a significant lack of clear information on what it truly takes to become a designer of handbags and fashion accessories.This course is crafted to assist both emerging and struggling designers in developing and articulating their ideas effectively for the prototyping phase. It addresses the needs and challenges faced by our customers, aiming to support and streamline the creative process for project realization.   WHO IS THIS COURSE FOR?This course is tailored for aspiring designers seeking professional advice from industry experts, individuals at the beginning of their design careers who require guidance to enhance their design process, or those simply looking to refine their drawing techniques for personal enjoyment.No previous experience is necessary.   WHAT WILL BE TAUGHT?Below is a list of topics covered during the classes:Understanding the role of a bag designerBefore designing: understanding and analsing crucial external aspects that will influence your business successAbout your business idea and profile: understanding the target audience, market placement, pricing strategy and more.Understanding what a moodboard is and how to use itUnderstanding the differences and purposes of illustrations vs technical drawingsUnderstanding the importance of construction and its impact on your designOverview of the anatomy of a handbag, lining and reinforcementsUnderstanding the structure of a collection: the use of a collection planLearning how to plan a balanced collection of fashion accessoriesUnderstanding finishing options for your designsUnderstanding hardware and its impact on the cost price of your collectionOverview of leather and vegan leatherIdentifying the right materials for your collectionLearning how to draw three-dimensional bagsSketching technical drawingsGoing through the product development of three designsDeveloping patterns and realising 1 to 3 three-dimensional mock-ups of your collectionProviding technical information about your collection to the prototype makerUnderstanding the prototyping processManufacturing your collection: how it works and what the options are HOW WILL THE CLASS BE TAUGHT?The class will take place in person at our London studio, and the lessons will alternate between theoretical instruction and practical exercises.Some homework will be assigned to students between lessons.   HOW LONG IS THIS TUITION?: This course spans two weeks and will be conducted from Monday to Friday, running from 10 am to 3.30 pm, with a 30-minute lunch break.   INCLUDED IN THE COURSE:You will also receive access to a collection of handouts providing relevant information, useful resources and support in continuing your designing process independently.The handouts will contain:– A glossary containing essential key words related to the topic of the lesson– An illustrated glossary containing information about type of bags and bags’ features– An illustrated guide on common hardware used in bags and accessories– Documents about leather types, finishings, tanning processes– Information about perspective and guides to be used as reference to develop your drawings– A list of recommended suppliers for both leather and fittings (physically in London and online)– A glossary containing information about leather types and characteristics   WHAT ARE THE ENTRY REQUIREMENTS?You should be able to use measurements and understand verbal and written English instructions.   ARE THERE ANY OTHER COSTS? IS THERE ANYTHING I NEED TO BRING?Materials to exercise with are included.Feel free to bring a notepad, if you would like to take some notes, we will provide the rest.