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
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Give a compliment to your career and take it to the next level. This Internal Audit Training bundle will provide you with the essential knowledge to shine in your professional career. Whether you want to develop skills for your next job or elevate your skills for your next promotion, this Internal Audit Training bundle will help you stay ahead of the pack. Throughout the Internal Audit Training programme, it stresses how to improve your competency as a person in your chosen field while also outlining essential career insights in the relevant job sector. Along with this Internal Audit Training course, you will get 10 premium courses, an originalhardcopy, 11 PDF certificates (Main Course + Additional Courses) Student ID card as gifts. This Internal Audit Training Bundle Consists of the following Premium courses: Level 2 Microsoft Office Essentials Microsoft Teams Leadership & Management Diploma Working from Home Essentials Mental Health and Working from Home Online Meeting Management Effective Communication Skills Time Management Report Writing Emotional Intelligence and Human Behaviour Take this course anywhere and at any time. Don't let your lifestyle limit your learning or your potential. Experienced tutors and mentors will be there for you whenever you need them, and solve all your queries through email and chat boxes. Learning Outcomes: Fully understand the purpose and requirements of an internal audit Learn all processes needed to perform an internal audit Develop methods to apply useful technology and measures to an audit Work out the best way to identify and control risk in operations Acquire the ability to perform employee interviews intuitively Obtain the capability to produce an incisive and accurate final report Adhere to accepted and recognised UK Internal Audit Standards Become a trusted and reliable auditor in your chosen sector and much more... Benefits you'll get choosing Apex Learning: One payment, but lifetime access to 11 CPD courses Certificates, student ID for the title course included in a one-time fee Full tutor support available from Monday to Friday Free up your time - don't waste time and money travelling for classes Accessible, informative modules taught by expert instructors Learn at your ease - anytime, from anywhere Study the course from your computer, tablet or mobile device CPD accredited course - improve the chance of gaining professional skills Gain valuable knowledge without leaving your home Curriculum: ***Internal Audit Training Diploma*** Module 01: Auditing as a Form of Assurance Module 02: Internal Audit Procedures Module 03: Technology-based Internal Audit Module 04: Internal Control and Control Risk Module 05: Audit Interviews Module 06: Reporting Audit Outcome Module 07: UK Internal Audit Standards Module 08: Career as an Auditor How will I get my Certificate? After successfully completing the course you will be able to order your CPD Accredited Certificates (PDF + Hard Copy) as proof of your achievement. PDF Certificate: Free (Previously it was £6*11 = £66) Hard Copy Certificate: Free (For The Title Course: Previously it was £10) CPD 45 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Anyone from any background can enrol in this Internal Audit Training bundle. Requirements This Internal Audit Training course has been designed to be fully compatible with tablets and smartphones. Career path Internal Auditor - £30-50k/year. External Auditor - £35-50k/year. Audit Manager - £40-70k/year. Risk Manager - £40-70k/year. Compliance Officer - £30-50k/year. Fraud Investigator - £25-45k/year. Certificates Certificate of completion Digital certificate - Included Certificate of completion Hard copy certificate - Included You will get the Hard Copy certificate for the title course (Leadership and InfluencingSkills) absolutely Free! Other Hard Copy certificates are available for £10 each. Please Note: The de.livery charge inside the UK is £3.99, and the international students must pay a £9.99 shipping cost
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This Applied Economics with Banking and Financial Markets is an excellent opportunity for you to learn multiple skills from the convenience of your own home and explore Applied Economics with Banking and Financial Markets 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