17 Educators providing Organisation courses in Soham

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

Employee Engagement 1 Day Training in Cambridge

Managing a Virtual Team Skills 1 Day Training in Cambridge

Overview This course is incredibly elegant to feed psychological feature feeling and confidence needed in an everyday work state of affairs so as to run the team and organisation to attain sensible results. it'll facilitate building your trust and loyalty and enhance your skills and your behaviour additionally it'll facilitate setting objectives, motivating and communicating together with your folks.

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.

Business Networking 1 Day Training in Cambridge

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.

Overview Extending business activities beyond organisational boundaries to create value for the organisation is not new. However, the quantity and complexity of the relationships that now exist beyond organisational boundaries are increasing, as is regulatory and stakeholder scrutiny. While partnerships with third parties, including critical suppliers, can be beneficial to the organisation on so many levels, such alliances can expose the organisation to many unknowns, and those unknowns will undoubtedly increase the level of risk. The key, then, is properly managing the infrastructure, systems, staff and outside support to adequately manage that risk. 

This module focuses on developing leadership confidence through self-discovery, emphasising the importance of understanding one's unique leadership style and personal philosophy. Participants will explore their core identity as leaders and learn strategies to enhance their influence, credibility, and relationships within their organisation. Exploring the link between self-discovery and effective leadership, focusing on developing confidence to lead from within. Testimonial: “Without guidance, personal branding can quickly become an exercise in aspiration and competition; letting the carefully curated public personas of others dictate our own validity and definition of success. Clarity on who we truly are, what matters to us and therefore how we position ourselves in the world takes reflection and time. Rachael’s work in this area has inspired the nearly 100 delegates who have been part of our HR Leadership Academy over the past 8 years, and I have no doubt will continue to resonate with future cohorts.” MD, Nina Metson - Suffolk

This half day course is designed to help participants learn more about the new legal form for charities, the Charitable Incorporated Organisation (CIO), which was introduced in January 2013. The session will set the context and background to the introduction of the CIO, explore its potential benefits (and weaknesses) when set against the company limited by guarantee structure and introduce the two constitution models – the Foundation version (where only trustees are members) and the Association model (where the organisation’s membership is wider). By the end of the course participants should have a deeper knowledge of the subject so that they are able to make a more informed choice as to whether this legal entity might work for their organisation.