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2620 Risk Management courses
Implementing Good Clinical Laboratory Practice
By Research Quality Association
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
Certified Asset Management Assessor (CAMA) Certification Preparatory Course
By EnergyEdge - Training for a Sustainable Energy Future
Gain the skills and knowledge you need to succeed as an Asset Management Assessor with our EnergyEdge course. Take the first step towards your career goals today!
Course Overview: Did you know 70% of organisations reported a cybersecurity breach last year? Network Security Level 2 is more than just a course; it invests in a safer digital future. This curriculum offers a meticulous journey, delving deeper into network security. From understanding the intricacies of Security and Risk Management to Security Operations, this course ensures comprehensive coverage. Whether you're keen on mastering Asset Security, seeking profound knowledge in Security Engineering, or aiming to understand the dynamics of Communication and Network Security, Identity and Access Management, Security Assessment and Testing, or Software Development Security, this course is tailored to equip you with the advanced knowledge necessary for the cybersecurity challenges of tomorrow. Take action now. Stay ahead of the curve, safeguard sensitive data, and become a beacon of trust in cybersecurity. Enrol today! Key Features of the Course: Awarded a CPD certificate upon completion. 24/7 Learning Assistance to ensure uninterrupted progress. Engaging learning materials designed by top industry experts. Who is This Course For? This Network Security Level 2 course is Ideal for professionals who have completed foundational courses in network security and are looking to further enhance their skills and knowledge. Learning Outcome Acquire an in-depth understanding of security protocols. Delve into Security and Risk Management. Understand the essence of Asset Security. Engineer robust security measures. Master Communication and Network Security. Manage Identity and Access effectively. Conduct Security Assessment and Testing proficiently. Implement efficient Security Operations. Secure software through development practices. Why Enrol in This Course: Stay ahead in the cybersecurity realm. This top-reviewed course, recently updated, is trending and empowers you with the skills to counteract the ever-evolving world of network threats. Requirements: Basic knowledge of network security principles. Completion of a foundational course in network security or equivalent experience. Career Path: Upon completion of this Network Security Level 2 course, professionals can explore numerous roles, such as: Security Analyst: £50,000 Network Security Engineer: £55,000 Cybersecurity Manager: £65,000 Security Consultant: £60,000 Information Security Officer: £58,000 Threat Intelligence Analyst: £53,000 Cybersecurity Architect: £62,000 Certification: Students will be awarded a CPD certificate upon successful completion, recognising their advanced Network Security Level 2 proficiency. FAQ What is Level 3 cyber security? Level 3 cyber security refers to a qualification or course that provides an advanced understanding of cybersecurity principles and practices. It is often designed for individuals with foundational cybersecurity knowledge who want to deepen their expertise. What are the 5 types of network security? The five types of network security are: Firewalls, which prevent unauthorised access to or from a private network; Antivirus and anti-malware software, which protect against malicious software; Intrusion Prevention Systems (IPS), which identify and prevent known threats; Virtual Private Networks (VPNs) which provide secure remote access; and Data Loss Prevention (DLP) prevents sensitive data from leaving the network. What is BTEC Level 2 cyber security? BTEC Level 2 cyber security is a qualification that provides an introduction to the principles and practices of cybersecurity. It is typically designed for individuals new to the field and seeking foundational knowledge. What is OCN NI Level 2 cybersecurity? OCN NI Level 2 cybersecurity is a qualification offered by the Open College Network Northern Ireland. It provides a foundational understanding of cybersecurity principles and practices and is designed for individuals new to the field. What is OCN Level 2 equivalent to? OCN Level 2 is equivalent to a GCSE grade A*-C or a Level 2 NVQ. An intermediate-level qualification provides a foundation in a specific subject area. What is OCN Level 2 qualification? OCN Level 2 qualification is an intermediate-level qualification that provides a foundational understanding of a specific subject area. It is typically designed for individuals who have completed basic education and seek to further their knowledge and skills. Course Curriculum 2 sections • 9 lectures • 02:12:00 total length •Security and Risk Management: 00:24:00 •Asset Security: 00:12:00 •Security Engineering: 00:15:00 •Communication and Network Security: 00:10:00 •Identity and Access Management: 00:10:00 •Security Assessment and Testing: 00:12:00 •Security Operations: 00:36:00 •Software Development Security: 00:13:00 •Assignment - Network Security Level 2: 00:00:00
