850 Quality Assurance courses delivered Online

Level 5 QLS Endorsed Course | Endorsed Certificate Included | Plus 5 Career Guided Courses | CPD Accredited

Course Information Join us for a comprehensive refresher focusing on crucial Good Laboratory Practice (GLP) requirements, including an emphasis on data integrity, recent developments, and emerging trends gleaned from MHRA inspections. The programme dives into specific domains such as risk assessment, OECD guidance on sponsor influence, and the advisory from OECD on QA. Additionally, delegates can benefit from a dedicated GLP clinic, facilitating discussions on understanding and upholding GLP compliance. Is this course for you? This course is tailored for study directors, principal investigators, test facility management, and QA professionals seeking to refresh their knowledge and responsibilities within the GLP framework. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Registration, Welcome and Introduction 09:20 Development of Good Laboratory Practice A reminder of the history of GLP, its current scope and application, with a synopsis of current UK, European and international standards. 09:50 Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA A reminder of the roles and responsibilities with regard to the GLP management and oversight of the Test Facility and the management and control of the study, as defined by GLP. 10:30 Break 10:45 Workshop 1 Workshop 1 Roles and responsibilities 11:15 Influence of Sponsors The published OECD Position Paper No. 21 regarding Possible Influence of Sponsors on conclusions of GLP Studies is reviewed and discussed. 11:45 Data Integrity The fundamentals of data integrity according to the OECD Guidance No. 22 on Data Integrity is discussed along with the responsibilities of Study Director, Test Facility Management, and study staff in ensuring the integrity of the GLP study data. 12:30 Lunch 13:15 Quality Assurance and GLP OECD Advisory No. 23 (Revision of OECD No.4)- A walk through of the changes to the OECD Guidance on the role and activities of Quality Assurance 13:45 Quality Improvement Tools and GLP The tools that might be considered for GLP and their role and operation when used in Test Facilities- OECD Position Paper No.24 published July 2022 14:15 Workshop 2 Workshop 2 Change control 14:30 Risk Assessment How should we assess risk and how can we use the process to assist in evaluation audit findings? 15:00 Break 15:15 Current hot topics in GLP Explore the current issues in Industry and trends /types of Regulatory inspection findings 15:50 GLP Clinic An opportunity to discuss any other issues regarding understanding and maintaining GLP Compliance. 16:30 Close of Course Extra Information 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 7 Points   Development Level Learn

3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 10 CPD Courses | Lifetime Access

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This training is for lawyers and covers key topics to ensure compliance with the Lexcel standard and other regulations.

Level 5 QLS Endorsed | 150 CPD Points| +Gifts: QLS Certificate + PDF Certificate | Lifetime Access| 24/7 Learner Support

Free Level 4 QLS Endorsed Certificate | CPD Accredited | 120 CPD Points | Advanced Learning Materials | Lifetime Access

3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | 10 CPD Courses | Lifetime Access | 24/7 Tutor Support

Assuring Quality Through Acceptance Testing: In-House Training It is also the business analyst's responsibility to confirm that the resulting solution developed by IT does, in fact, solve the defined problem. This is done first through testing, especially acceptance testing, and then through monitoring of the installed solution in the user community. It is the business analyst's job to define the business problem to be solved by IT. It is also the business analyst's responsibility to confirm that the resulting solution developed by IT does, in fact, solve the defined problem. This is done first through testing, especially acceptance testing, and then through monitoring of the installed solution in the user community. The business analyst is not only concerned with the testing itself, but also with the management and monitoring of the users doing the acceptance testing, and recording, analyzing, and evaluating the results. What you will Learn Upon completion, participants will be able to: Create a set of acceptance test cases Manage and monitor an acceptance test stage where users perform the testing Work with the development team in the systems testing stage Assess the solution once it is in the business environment Foundation Concepts The role of the business analyst An introduction to the BABOK® Guide BA roles and relationships through the project life cycle Introduction to assuring software quality through acceptance testing The Scope of IT Testing Overview of testing stages The testing process Testing documentation Pre-Acceptance Testing The BA's role in testing Early development testing stages (unit and integration) Late development testing stage (system) The Acceptance Test Stage - Part I (Planning, Design, and Development) Overview of user acceptance testing Acceptance test planning Designing user acceptance tests Developing individual user acceptance test cases Building effective user acceptance test scenarios The Acceptance Test Stage - Part II (Execution and Reporting) Operating guidelines Execution Reporting Post-Acceptance Testing Overview Project implementation Project transition (project closure) Production through retirement Testing Commercial Off-the-Shelf (COTS) Software Overview Selecting the software Implementing the software Summary What did we learn and how can we implement this in our work environments?