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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The NVQ Diploma in Construction Contracting Operations Management qualification is suited to those who are working in a management role in the construction industry and are looking to become eligible for the Black CSCS Card. Candidates follow one of five pathways depending on their job role: General Estimating Buying Planning Surveying Our team will discuss the qualification process with you prior to signing up in order to ensure that you will be able to complete the qualification. Every candidate is assigned a competent and experienced assessor who will provide advice and guidance throughout the programme to ensure that candidates are supported in the successful completion of the qualification. CSCS Cards We can provide CSCS tests and CSCS cards alongside your qualification without the need to attend the test centre. Speak to our friendly and helpful team for more information.
Overview It is very important to analyse financial operations within financial functions or outside financial functions. If they are utilized and implemented properly it will contribute towards the success of the business. This program will give you in-depth knowledge of financial operations and reporting supported by important aspects of theory together with practical methods and techniques. This course is specially designed by experts who have a wealth of experience in the related field. In this course, you'll gain knowledge in financial operations and reporting as well as its foundations, methods and techniques.
About this Training Course On a day-to-day basis, one of the most common technologies utilised in well intervention is Coiled Tubing. This is prevalent in the oil industry and the technology is used during drilling, completion and production phases of Oil & Gas wells worldwide. This 5 full-day course will look at the following areas: Equipment for surface and pressure control Assembly components for bottom-hole Details of the different types of interventions performed with Coiled Tubing, and How to deal with fatigue and corrosion. The aim of this course is to enable the participants to gain key knowledge that they will require to actively and efficiently participate in the planning, design, and / or execution of a Coiled Tubing intervention. With this, the participants will learn how to calculate the string operating limits and the volumes and rates during nitrogen interventions. The course will walk the participants through the emergency responses and contingencies to deal with in various scenarios. Time will be allocated for the participants to work on the practical exercises as well as real field cases and problems. This course can also be offered through Virtual Instructor Led Training (VILT) format. Training Objectives By the end of the course, the participants will be able to: Plan, design, manage and execute interventions for Coiled Tubing Enhance operational performance during interventions for Coiled Tubing Explain the recommended equipment for various Coiled Tubing field conditions and applications Discuss the proper pressure control equipment for any particular well condition Learn about the most commonly used downhole tools and explain their function Understand how to calculate and define string limits for Coiled Tubing Learn how to work safely with liquid nitrogen Target Audience This course is aimed at Drilling and completion engineers Production engineers Surface/subsurface engineers Operations engineers Service company managers Field engineers This course will also benefit professionals who would like to increase their knowledge in the planning, design and/or execution of Coiled Tubing and Liquid Nitrogen interventions. Course Level Basic or Foundation Training Methods Other than the daily quizzes to reinforce the materials presented in the session, the participants will work through exercises such as: Selecting suitable BHAs for various operations Rigging up equipment in the correct order and preparing an outline testing programme Carrying out suitable calculations to perform an N2 lift Preparing an outline programme for a balanced cement plug Identifying issues in various videos & photos and suggesting mitigations Basic N2 safety quiz Final exercise will be preparing an outline programme for a Proppant Clean out, including a detailed Risk Register and Mitigation options Trainer Your expert course instructor has over 40 years of experience in the Oil & Gas industry. During that time, he has worked exclusively in well intervention and completions. After a number of years working for intervention service companies (completions, slickline & workovers), he joined Shell as a well service supervisor. He was responsible for the day-to-day supervision of all well intervention work on Shell's Persian/Arabian Gulf platforms. This included completion running, coil tubing, e-line, slickline, hydraulic workovers, well testing and stimulation operations. An office-based role as a senior well engineer followed. He was responsible for planning, programming and organising of all the well engineering and intervention work on a number of fields in the Middle East. He had a brief spell as a Site Representative for Santos in Australia before joining Petro-Canada as Completions Superintendent in Syria, then moved to Australia as Completions Operations Superintendent for Santos, before returning to Shell as Field Supervisor Completions and Well Interventions in Iraq where he carried out the first ever formal abandonment of a well in the Majnoon Field. While working on rotation, he regularly taught Completion Practices, Well Intervention, Well Integrity and Reporting & Planning courses all over the world. In 2014, he started to focus 100% on training and became the Technical Director for PetroEDGE. Since commencing delivering training courses in 2008, he has taught over 300 courses in 31 cities in 16 countries to in excess of 3,500 participants. POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations
Level 6 NVQ Diploma in Construction Contracting Operations Management
Our training programme will provide those involved at any stage of the process for procuring goods and/or services within their organisations with the knowledge and skillset to identify and mitigate the threat posed by the breadth and multi-layered complexity of procurement fraud, corruption and associated financial crime and money laundering.
Our training programme will provide those involved at any stage of the process for procuring goods and/or services within their organisations with the knowledge and skillset to identify and mitigate the threat posed by the breadth and multi-layered complexity of procurement fraud and corruption.