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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
In this course, you will learn how to create an AAA-looking scene in Unreal Engine 5 from scratch. This class is not for beginners; therefore, no basics of Unreal Engine 5 will be covered. You should be able to know how to navigate and have basic knowledge of the Unreal Engine 5 Interface.
Be enthralled in a full guide to building a game environment in UE5, from creating a landscape to making water flow through your mountains, and learn the best way to place environmental details with this course for beginners. We will go over the entire Quixel library and add realistic elements using the Niagara particle system to build our 3D environments.
Dive deep into the intricacies of 'Customer Service & Environment' with our comprehensive course. Explore the vital concepts that shape exceptional customer service, discover the art of effective organisation and management, and navigate the digital world with the inclusion of social media tools. As brands evolve in today's digital age, understanding the relationship between customers and their chosen brands has never been more crucial. Enrol now to propel your knowledge in this dynamic domain. Learning Outcomes Understand the fundamental concepts underpinning successful customer service delivery. Learn the strategies to organise and structure optimal customer service. Gain insights into effective Customer Relationship Management (CRM) techniques. Comprehend the interplay between customer satisfaction and brand loyalty. Master the use of social media tools to enhance business customer relations. Why buy this Customer Service & Environment course? Unlimited access to the course for forever Digital Certificate, Transcript, student ID all included in the price Absolutely no hidden fees Directly receive CPD accredited qualifications after course completion Receive one to one assistance on every weekday from professionals Immediately receive the PDF certificate after passing Receive the original copies of your certificate and transcript on the next working day Easily learn the skills and knowledge from the comfort of your home Certification After studying the course materials of the Customer Service & Environment there will be a written assignment test which you can take either during or at the end of the course. After successfully passing the test you will be able to claim the pdf certificate for £5.99. Original Hard Copy certificates need to be ordered at an additional cost of £9.60. Who is this Customer Service & Environment course for? Aspiring customer service managers aiming for excellence. Brand strategists focused on enhancing customer relationships. Business owners seeking to elevate their customer service standards. Digital marketers keen on leveraging social media tools for businesses. Customer relations officers eager to resolve client issues efficiently. Prerequisites This Customer Service & Environment does not require you to have any prior qualifications or experience. You can just enrol and start learning.This Customer Service & Environment was made by professionals and it is compatible with all PC's, Mac's, tablets and smartphones. You will be able to access the course from anywhere at any time as long as you have a good enough internet connection. Career path Customer Service Manager: £30,000 - £45,000 Brand Strategist: £35,000 - £50,000 Business Consultant focusing on Service Delivery: £40,000 - £60,000 CRM Specialist: £32,000 - £48,000 Social Media Manager: £28,000 - £42,000 Customer Relations Officer: £25,000 - £37,000 Course Curriculum Module 01: Concepts and Practices in Customer Service Delivery Concepts and Practices in Customer Service Delivery 00:13:00 Module 02: Organise Customer Service Delivery Organise Customer Service Delivery 00:14:00 Module 03: Structure of Customer Service Structure of Customer Service 00:14:00 Module 04: Customer Relationship Management (CRM) Customer Relationship Management (CRM) 00:18:00 Module 05: Customer Satisfaction & Relationship with Brand Customer Satisfaction & Relationship with Brand 00:15:00 Module 06: Monitoring and Resolution of Customers' Complaints & Problems Monitoring and Resolution of Customers' Complaints & Problems 00:15:00 Module 07: Social Media Tools and Channels for a Business Social Media Tools and Channels for a Business 00:15:00