9845 Courses

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

Blue CSCS Card NVQ Level 2 Craft This qualification provides you with the opportunity to showcase their knowledge, skills and understanding in their chosen craft. You will have the relevant experience in one of the trade specific areas. You will work in one of the following areas: Trowel Occupations (Bricklayer) Building Maintenance Painting and Decorating Wall and Floor Tiling Stone Masonry Wood Occupations (site Carpentry) Plastering Roofing Induction - As soon as you register you will be given a dedicated assessor. They will arrange an induction and together with your assessor, you will get to decide on the pathway which best proves your competency. The induction is used to plan out how you will gather the relevant evidence to complete the course. During the course - The assessor will work with you to build a portfolio of evidence that allows you to showcase your knowledge, skills and experience. The assessor will also regularly review and provide you with feedback. This will allow you to keep on track to progress quickly. You will be assessed through various methods such as observations, written questions, evidence generated from the workplace, professional discussion, and witness testimonials. On completion - Once all feedback has been agreed, the Internal Quality Assurer will review your portfolio and in agreement with your assessor the certificate will be applied for. To download our PDF for this course then please click here.

Understand why it is difficult for us to accept changes when they occur - both in our personal and professional lives. Outline the emotional stages of the change curve which maps out distinct stages all individuals go through after a change, and learn to utilise a range of strategies to cope with changes.

Equipment used - Lorry mounted cranes and Hook attachments. Who Would Do This Training? Anyone who operates or intends to be operating lorry mounted cranes (sometimes referred to as HIAB’s) should undertake training as is required by the Lifting Operations and Lifting Equipment Regulations 1998. This course is made to suit novice operators, and are designed to ensure the efficient and safe operation of equipment. HIAB is really a brand name and the correct term for the equipment is ‘lorry mounted crane’ or ‘lorry loader crane’ (when mounted to a commercial vehicle). Other manufacturers of these types of cranes include Atlas, Cormach, Fassi, HMF, Hyva, Palfinger, Penny Hydraulics and PM. Which Industries Train with ALLMI? The ALLMI Lorry Loader Course is recognised by CSCS. The Lorry Loader Crane courses and Slinger Signaller courses, certificated by ALLMI, cover a wide variety of hydraulic cranes, both manually and electronically operated. Manuals and Postage of ALLMI Certificate and Card are included in your Ticket Price

Equipment used - Lorry mounted cranes and Hook attachments. Who Would Do This Training? Anyone who operates or intends to be operating lorry mounted cranes (sometimes referred to as HIAB’s) should undertake training as is required by the Lifting Operations and Lifting Equipment Regulations 1998. This course is made to suit novice operators, and are designed to ensure the efficient and safe operation of equipment. HIAB is really a brand name and the correct term for the equipment is ‘lorry mounted crane’ or ‘lorry loader crane’ (when mounted to a commercial vehicle). Other manufacturers of these types of cranes include Atlas, Cormach, Fassi, HMF, Hyva, Palfinger, Penny Hydraulics and PM. Which Industries Train with ALLMI? The ALLMI Lorry Loader Course is recognised by CSCS. The Lorry Loader Crane courses and Slinger Signaller courses, certificated by ALLMI, cover a wide variety of hydraulic cranes, both manually and electronically operated. Manuals and Postage of ALLMI Certificate and Card are included in your Ticket Price

Equipment used - Lorry mounted cranes and Hook attachments. Who Would Do This Training? Anyone who operates or intends to be operating lorry mounted cranes (sometimes referred to as HIAB’s) should undertake training as is required by the Lifting Operations and Lifting Equipment Regulations 1998. This course is made to suit novice operators, and are designed to ensure the efficient and safe operation of equipment. HIAB is really a brand name and the correct term for the equipment is ‘lorry mounted crane’ or ‘lorry loader crane’ (when mounted to a commercial vehicle). Other manufacturers of these types of cranes include Atlas, Cormach, Fassi, HMF, Hyva, Palfinger, Penny Hydraulics and PM. Which Industries Train with ALLMI? The ALLMI Lorry Loader Course is recognised by CSCS. The Lorry Loader Crane courses and Slinger Signaller courses, certificated by ALLMI, cover a wide variety of hydraulic cranes, both manually and electronically operated. Manuals and Postage of ALLMI Certificate and Card are included in your Ticket Price

ISTQB® FOUNDATION TRAINING COURSE (2 persons minimum) The aim of this course is to provide you with the knowledge and skills to pass an exam certifying you as an ISTQB® Certified Tester - Foundation Level. Most organisations require this certification as a minimum skill requirement for software testers. In this course you will learn a standardized approach to software testing that will be immediately applicable to your projects. In order to get the certification you will be required to pass a 60-minute exam. Our trainers will fully prepare you by employing scenarios that mirror the exam questions, and by focusing course delivery with a balance of theory and practice. Target group: Functional Tester, Agile Tester, User Acceptance Tester, Test Automation Specialist, Performance Testing Specialist, Testing Team Lead, Test Manager, Business analyst Prerequisites: There are no specific prerequisites for this course. This course is suitable for anyone involved in software testing. Duration: 3 days. Training objectives: Learn aspects of test planning, estimation, monitoring and control. Understand and use international standards and terminology. Understand and implement effective testing techniques. Be well prepared for the exam. Identify the missing testing skills for the career development purposes. This course covers the following areas: Fundamentals of software testing Testing throughout the life cycle (software development models, test levels, test types) Test design techniques (e.g. specification-based or black-box techniques, structure-based or white-box techniques) Static testing (static testing techniques, review process, tool-assisted static analysis) Test management (test organisation, test planning and estimation, test progress monitoring and control, risks) Tools to support testing (types, benefits and risks) Language: English

Emotional Intelligence Training

These qualifications would be beneficial for someone who is working in or who is learning to work in assessment of quality assurance roles. These qualifications are valid for assessing company devised assessments, as well as national standards and qualifications.

Facilitation Skills Training