3131 Development courses in Sheffield delivered Live Online

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

Overview This course will define the scope of work, project goal, project plan, project phase, sequencing and phase relationship Project Planning & Budgeting will provide participants with a demonstrated set of methods, processes, tools and techniques to cultivate a systematic and dynamic project plan to certify progressive monitoring control and reporting of the project cost.

Overview Tendering is a process on which a lot of money relies. When a tender is issued and published, winning that contract is completely depended on how deeply you understand the tender, the key areas of the tender along with how much in-depth knowledge you have about the potential client's need and how you can provide your service to those needs.

Overview EPC (Engineering, Procurement and Construction) is a very challenging area and is very competitive as well. Companies dealing with large and complex EPC projects are more often get involved in mitigation by complex contract laws and management that lead to huge financial losses. It is very important to Know-how EPC contract laws, and their commercial and financial aspects to gain skills and the ability to deal with complex contract laws and reduces the risk. 

Overview The course focuses on topics such as the fundamental concepts of auditing and quality management, principles of internal and external audit, auditing processes and tools, principles and practice of root cause analysis, communication and people skills, and other related topics. Students who successfully complete this course will gain the essential knowledge and skills necessary to become successful auditors and work with confidence to improve the processes in their organizations.

Overview Strategic Financial Management and Effective Budget Execution also called Strategic Financial Management provide the important elements for attaining a comprehensive budget preparation and effective execution system. This course focuses on the risks and challenges likely to obstruct the operation of management and financial accounting processes and evaluates the techniques and tools needed to tackle them. It will highlight what constitutes strategic financial management and effective budget execution within the context of achieving their strategic and operational objectives.

Overview With the change in the density of enterprise risk, new risks have emerged, and managing it has become everyone's responsibility. The new Enterprise Risk Management course offers you the exclusive opportunity to learn the concepts and principles of the newly updated ERM framework and to integrate the framework into your organisation's strategy. The course is designed with all the modules to provide you with the knowledge necessary to understand and apply Enterprise Risk Management - Integrating with Strategy and Performance. The ERM framework assists management and boards of directors with their respective duties for managing risk.

Overview This course will help you manage project risk effectively by identifying, analyzing, and communicating inevitable changes to project scope and objectives. You will understand and practice the elements needed to measure and report on project scope, schedule, and cost performance. You will be equipped with the tools to manage change in the least disruptive way possible for your team and other project stakeholders.

Overview Competitor Analysis is a key area every professional does to understand their business presence. It gives your insight into your business standings and also knowledge of your competitors and their strength and weakness. Analysing your competitors helps you understand the market and your power to deal with the competitors.  It is an essential marketing and strategic tool. It provides both an offensive and defensive strategic tool to analyse opportunities and threats.

Overview To understand the course thoroughly, you need to understand the practical application of the theory along with case studies as well as relevant examples. IT Project Management course will include those areas in managing the processes and activities related to guaranteeing the success of IT projects.