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3015 Dele courses

Auditing Computerised Systems

By Research Quality Association

Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 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 19 Points Development Level Develop

Auditing Computerised Systems
Delivered in person or OnlineFlexible Dates
£1,297 to £1,687

Lean Six Sigma Green Belt - ROI (Dublin/Galway/Limerick)

By Centre for Competitiveness

Become a certified Lean Six Sigma Green Belt with our dynamic, interactive, and project based training sessions, now running in the Republic of Ireland.

Lean Six Sigma Green Belt - ROI (Dublin/Galway/Limerick)
Delivered In-Person in Dublin + 2 moreFlexible Dates
£1,800

Certified Lean Six Sigma Green Belt Training November 2024

By Centre for Competitiveness

Course Overview Lean Six Sigma is a proven combination of tools and techniques that has been used by leading organizations to improve efficiency, productivity and customer satisfaction. It achieves this by providing a rigorous and structured methodology and team approach to problem solving which leads to quality and performance improvements. Our Lean Six Sigma Green Belt training is a seven-day programme which includes an in-house project designed to provide participants with an understanding of the Six Sigma Green Belt Process and it’s practical application.  Trainees will enhance their current skills by developing a thorough understanding of the DMAIC (Define/Measure/Analyse/Improve/Control) methodology and its applications, creating a culture of problem solving and continuous improvement in their organization. In this way, key personnel become valuable contributors in achieving the larger goals and objectives of their organization. This powerful tool will enable you and your team to identify opportunities for improvement, and assist in the implementation of projects leading to efficiency by equipping key personnel with the expertise and the tools needed to manage and participate in cost reduction projects with innovative solutions.  Trainees will learn how to use data to pinpoint processes that need to be analysed and improved using the Six Sigma Tool sets, with a view to problem solving, increasing operational efficiency, improving productivity and customer satisfaction and the company’s overall business results. Our Lean Six Sigma Green Belt programme incorporates a project to be undertaken in your own organization during and after the training modules. This allows you to apply the tools, in your own working environment, to processes that are known to you, making the training relevant, and also leaving a improvement with measurable results in your organization. MINITAB (trial version can be downloaded free) and Excel software are used by participants during the training sessions and to complete their projects. Structure of the Course This 7-day training programme is divided into three modules as follows:  Define / Measure Phase - 3 days from Nov 25th to 27th, 2024 Analyse Phase - 2 days on January 13th &14th, 2025 Improve / Control Phase - 2 days on February 17th & 18th, 2025 A gap of 4 weeks between each module provides an opportunity for trainees to work on a project within their workplace, applying the methodology and tools learned during the previous module. Extra support can be provided between modules for each trainees with their project work. We provide a Lean Six Sigma Green Belt Manual for all delegates, and a Certification is awarded upon completion of the Green Belt training and ONE project by each trainee in which the targeted outcomes have been achieved. An outcome report and/or project presentation which demonstrates the use of the tools and methodology is required. Cost: £1,800 + VAT per person. What is included Seven days of face-to-face training delivered in 3 modules as listed above Project review and support for all participants during modules 2 & 3. Remote support available for the duration of the programme for trainees to consult with the trainer. All training material, and a Lean Six Sigma Green Belt Manual for all delegates Refreshments and lunch provided each day of training Free car park for all delegates Lean Six Sigma Green Belt certificate In-house Option This workshop can also be delivered in-house as a stand-alone training workshop or integrated into wider improvement activities. Contact us for more details at compete@cforc.org and we will be happy to discuss in the context of your own business needs. If you are not yet a member but are already thinking about joining CforC, you can find more information on how to become a member and the benefits by clicking here.

Certified Lean Six Sigma Green Belt Training November 2024
Delivered In-PersonFlexible Dates
£1,800

Concise Cisco switching

5.0(3)

By Systems & Network Training

Concise Cisco switches course description A hands on course covering the product specifics of Cisco switches. Installation, configuration, maintenance and troubleshooting are all covered in a practical oriented way. VLANs often take up a large part of the course. The course covers all interfaces but concentrates on using the command line interface. Delegates are, however, free to use the web based interface in all exercises. What will you learn Install Cisco switches. Use the command line interface and the web based interface to manage Cisco switches. Configure and troubleshoot Cisco switches. Perform software upgrades and maintain configurations using TFTP. Concise Cisco switches course details Who will benefit: Anyone working with Cisco switches. Particularly aimed at engineers and technicians supporting Cisco switches. Prerequisites: None. Duration 2 days Concise Cisco switches course content Ethernet review Single segment Ethernet, CSMA/CD, Broadcast domains, collision domains. Hubs, Extending the LAN. Hands on Hub based Ethernet. Cisco switches What are switches, frame forwarding and filtering, the forwarding database. Hands on Switched based Ethernet. Configuring Cisco switches Accessing the switch, installing the switch, The CLI, connecting PCs using the switch. Hands on Configuring Cisco switches. The command line interface User and privilege modes, online help, show, basic troubleshooting. The configuration editor, Global, major and sub commands, enable, secret and other passwords. Hands on Simple troubleshooting using the CLI. Port configuration Speed, duplex, security, trunking. Hands on Port trunking. Spanning Tree Protocol Spanning Tree, Loops, effect, root bridges, bridge port states, STP reconfiguration. RSTP and variants. Hands on STP. VLANS What are VLANs, configuring VLANs, access ports and trunks, 802.1Q, inter VLAN routing. Hands on Access ports, trunks, layer 3 switching. Housekeeping Configuration management, software management, password recovery. Hands on TFTP. Managing interconnection devices SNMP, RMON, RMON II. Troubleshooting LEDs, CDP, logging, Layer 1, layer 2, layer 3. Hands on Fixing things.

Concise Cisco switching
Delivered in Internationally or OnlineFlexible Dates
£1,497

SDH foundation

5.0(3)

By Systems & Network Training

SDH training course description Our SDH training course is designed for those with a basic knowledge of the principles of telecommunication digital transmission techniques. An overview of the existing transmission hierarchies and their limitations is provided with an introduction to the Synchronous Digital Hierarchy (SDH). The advantages of SDH are explained fully. What will you learn Identify the major limitations of the PDH network. Outline the advantages of using the SDH. Illustrate the various SDH equipment and network topologies. Describe the principles of the SDH multiplexing structure. SDH training course details Who will benefit: Anyone working with SDH. Prerequisites: It should be noted that this course will assume some basic telecommunication transmission knowledge from the delegates attending. This may be accomplished by attending the Introduction to Telecommunications course. Duration 2 days SDH training course contents Introduction to SDH Timing and synchronisation of digital signals, the plesiochronous digital hierarchy (PDH), the synchronous digital hierarchy (SDH), service protection with SDH SDH Multiplexing Techniques The multiplexing principles of SDH, mapping and aligning a 2Mbit/s tributary into a TU-12, aligning the VC-12 in a TU-12, multiplexing TU-12's into a TUG-2, multiplexing TUG-2's into a TUG-3, multiplexing TUG-3's into a VC-4, the VC-4 path overhead, the STM-1 frame, the AU-4 pointer, the STM-1 section overheads, multiplexer section protection, transmission at rates higher than STM-1, concatenation line transmission functions in SDH SONET Multiplexing Techniques Mapping a DS1 tributary into a virtual tributary, aligning the VT-SPE into a VT frame, mapping the VTGs into a STS-1 SPE, the STS-1 synchronous payload envelope, the STS-1 frame SONET network sections and lines transmissions at higher rates than STS-1 SDH Functions and Facilities SDH network topologies, structure of SDH equipment, synchronisation of SDH networks, protection switching in SDH networks, SDH alarm structure, SDH performance monitoring, testing of SDH, equipment and systems, network management and SDH, asynchronous transfer mode (ATM), future services and technologies OSI Telecommunications Network Management Definition of network management, managing telecom equipment, the managed object library, the management information base, the telecommunications management network (TMN), the Q3 protocol.

SDH foundation
Delivered in Internationally or OnlineFlexible Dates
£1,497

HP ProCurve switches for engineers

5.0(3)

By Systems & Network Training

HP ProCurve training course description A hands on course covering the product specifics of HP switches. Installation, configuration, maintenance and troubleshooting are all covered in a practical oriented way. VLANs often take up a large part of the course. The course covers all interfaces but concentrates on using the command line interface. Delegates are, however, free to use the web based interface in all exercises. What will you learn Install HP ProCurve switches. Use the command line interface and the web based interface to manage HP ProCurve switches. Configure and troubleshoot HP ProCurve switches. Perform software upgrades and maintain configurations using TFTP. HP ProCurve training course details Who will benefit: Anyone working with HP switches. Particularly aimed at engineers and technicians supporting HP switches. Prerequisites: None. Duration 2 days HP ProCurve training course content Introduction Traditional Ethernet, Hubs, Frames, MAC addresses. Hands on Building a network with a hub What is a switch? Switches versus hubs, the MAC address table, handling unknown addresses. Hands on Building a network with HP switches. Configuration methods How to configure a HP switch using: Console port access menus, CLI, telnet, web based access. Hands on Console access, show commands, using the menus, IP address configuration, telnet. Command Line Interface Operator mode, Manager mode, configuration mode, passwords, online help, CLI commands, basic troubleshooting. Hands on More show commands, basic troubleshooting, setting a password, displaying status and counters. Web based interface Web access, basic format, Getting started. SSL. Hands on Web based configuration. Port configuration Common port configuration tasks, port security, port aggregation. Hands on Configuring ports. Trunking and failover. STP configuration Broadcast storms. What is STP? RSTP. Configuring STP. Hands on Enabling and disabling STP, investigation failover. VLAN configuration What are VLANS? 802.1Q, tagged/untagged, creating VLANS, applying VLANS. Addressing and VLANs, Layer 3 switches and VLANs. Hands on Setting up VLANS, setting up tagged ports, Inter VLAN traffic. Housekeeping TFTP, software upgrades, downloading configurations. Hands on Software upgrade, downloading a configuration. SNMP SNMP configuration, HP OpenView. Hands on Using SNMP to manage a HP ProCurve switch. Basic troubleshooting Putting it all together. Layer 1 troubleshooting, Layer 2 troubleshooting. Miscellaneous exercises CDP. Logging

HP ProCurve switches for engineers
Delivered in Internationally or OnlineFlexible Dates
£1,497

HP Switches for engineers

5.0(3)

By Systems & Network Training

HP switches training course description A hands on course covering the product specifics of HP switches. Installation, configuration, maintenance and troubleshooting are all covered in a practical oriented way. VLANs often take up a large part of the course. The course covers all interfaces but concentrates on using the command line interface. Delegates are, however, free to use the web based interface in all exercises. What will you learn Install HP switches. Use the command line interface and the web based interface to manage HP switches. Configure and troubleshoot HP switches. Perform software upgrades and maintain configurations using TFTP. HP switches training course details Who will benefit: Anyone working with HP switches. Particularly aimed at engineers and technicians supporting HP switches. Prerequisites: None. Duration 2 days HP switches training course content Introduction Traditional Ethernet, Hubs, Frames, MAC addresses. Hands on Building a network with a hub. What is a switch? Switches versus hubs, the MAC address table, handling unknown addresses. Hands on Building a network with HP switches. Configuration methods How to configure a HP switch using: Console port access menus, CLI, telnet, web based access. Hands on Console access, show commands, using the menus, IP address configuration, telnet. Command Line Interface Operator mode, Manager mode, configuration mode, passwords, online help, CLI commands, basic troubleshooting. Hands on More show commands, basic troubleshooting, setting a password, displaying status and counters. Web based interface Web access, basic format, Getting started. SSL. Hands on Web based configuration. Port configuration Common port configuration tasks, port security, port aggregation, Hands on Configuring ports. Trunking and failover. STP configuration Broadcast storms. What is STP? RSTP. Configuring STP. Hands on Enabling and disabling STP, investigation failover. VLANs What are VLANS? 802.1Q, tagged/untagged, creating VLANS, applying VLANS. Addressing and VLANs, Layer 3 switches and VLANs. Hands on Setting up VLANS, setting up tagged ports, Inter VLAN traffic. Housekeeping TFTP, software upgrades, downloading configurations. Hands on Software upgrade, downloading a configuration. SNMP SNMP configuration, HP OpenView NNM. Hands on Using SNMP to manage a HP switch. Basic troubleshooting Putting it all together. Layer 1 troubleshooting, Layer 2 troubleshooting. Miscellaneous exercises CDP. Logging

HP Switches for engineers
Delivered in Internationally or OnlineFlexible Dates
£1,497

Introduction to Computer Systems Validation

By Research Quality Association

Course Information Join our comprehensive three-day training programme tailored for individuals seeking a foundational grasp of computerised system validation. This course equips participants with essential knowledge to effectively validate systems within their respective organisations for utilisation in GxP (GLP, GCP, GMP, GDP, and GPvP) environments. Attendees will also gain proficiency in auditing validated computerised systems, ensuring compliance with pertinent GxP regulations. Commencing with an overview of regulatory prerequisites and the system life cycle, the course transitions into practical aspects, centered around validating computerised systems and conducting subsequent audits. Engage in a dynamic blend of presentations, interactive discussions, and hands-on practical workshops throughout the course. This course will provide delegates with an understanding of the computerised system validation process, including: Definition of end user requirements Risk management, including supplier assessment and techniques for audit planning Validation planning and reporting Linking system development with good business practices Formal testing and qualification Understanding of data integrity and security issues How to assess system validation documentation to verify compliance. Is this course for you? IT professionals new to implementing computerised systems into regulated environments Quality professionals who monitor or audit computerised systems System owners, end users, tester and project staff. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome, Introduction and Course Objectives 09:45 Why Validate? Regulations and Guidance on Computerised System Validation Overview of the regulations and guidance applicable to CSV and their key expectations. 10:30 Break 10:45 The System Lifecycle The concept of the SLC and the key outputs from it. 12:00 Lunch 12:45 The Validation Process The approach to validation for different system types and a look at some of the key deliverables. 14:00 Project Introduction 14:15 Exercise 1 - User Requirements Capturing, agreeing and documenting the user requirements for a system. 15:15 Break 15:30 Exercise 1 - Feedback 16:00 Risk Management Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for three systems. 17:00 Questions and Answers Answers to any outstanding questions from Day 1. 17:15 Close of Day Day 2 09:00 Supplier Assessment The different approaches to supplier assessment and the things to be considered when assessing a supplier. 10:15 Exercise 2 - Supplier Assessment Planning a vendor audit with a focus on the key validation deliverables. 11:00 Break 11:15 Exercise 2 - Feedback 11:45 Test Overview and Test Planning The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing. 12:45 Lunch 13:30 Test Overview and Test Planning Continued. 14:15 Test Script Design, Execution and Review What a good test script looks like and the key things to consider when creating, executing and reviewing a test script. 15:30 Break 15:45 Exercise 3 - Creating a Test Script Create a test script based on user requirements created on Day 1. 17:15 Close of Day Day 3 09:00 Exercise 3 Feedback 09:30 Infrastructure Configuration and Qualification 10:30 Break 10:45 Validation Reporting Overview of the Validation Report and what should be included in it. 11:15 Maintaining the Validated State The procedures and records needed to ensure the system remains fit for purpose. 12:30 Lunch 13:15 Change Control Key concepts related to making changes to validated systems. 14:00 Data Integrity and Security How can we assure the integrity and security of our data. 15:15 Break 15:30 Course Objectives Summary and Panel Discussion A round up of key learning from the course. 17:00 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 19 Points Development Level Develop

Introduction to Computer Systems Validation
Delivered In-PersonFlexible Dates
£1,297 to £1,687

A System Approach to Good Pharmacovigilance Practice

By Research Quality Association

Course Information In today's evolving landscape, pharmacovigilance (PV) systems face ongoing challenges due to global, national, and company-specific events. This course focuses on developing personnel equipped to navigate these complexities and improve the safe use of medicinal products. We emphasise continuous global thinking, communication, and strategic planning, ensuring adaptability across various levels. The course explores maintaining PV system functionality while adhering to regulatory requirements. Participants will apply European regulatory standards to enhance and sustain PV system effectiveness, contributing to improvement initiatives and ensuring operational integrity. The course covers PV system intricacies, regulatory compliance, and a 'systems approach' for auditors, quality assurance personnel, and PV practitioners. Through presentations and workshops, attendees gain insights into implementing and maintaining an effective PV system. Who should attend? Auditors Pharmacovigilance Quality System Managers Pharmacovigilance scientists The QPPV. Course benefits Throughout the course delegates will explore application of the legal requirements for the PV system and quality system and how to assure these systems. They will demonstrate their ability to contribute to: A systematic investigation of the pharmacovigilance system and its quality system Examination of how the pharmacovigilance system and quality system interact to achieve compliance. The risk-based approach to auditing the PV system and quality system The maintenance of 'inspection readiness' Explore how to investigate the complex PV system Discussions about how to monitor and maintain the PV system and assure compliance. Course Objectives Clarify what has to be done: Explore application of the legal requirements. Explore how to do what has to be done: Adopt a systemic approach to systematically investigate or implement and maintain the PV system and quality system Examine how a compliant PV system and a compliant quality system interact to achieve compliance with regulatory requirements for PV Explore how to investigate the complexity of the PV system. Discus how to identify what is missing or what needs to be improved: Discuss how to monitor and maintain the PV system and assure compliance. This course will assist delegates with: An understanding of key system principles, A practical approach to implementing, maintaining and monitoring the PV system and its quality system A procedure to share expertise to increase efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas - Share knowledge and experiences - Solve specific problems.  By the end of the course delegates will be able to: Understand better the pharmacovigilance system, its quality system and how the components interact to achieve the objectives of pharmacovigilance Investigate, and analyse the pharmacovigilance system and to identify what is missing and what needs to be improved. Tutors Tutors will be comprised of (click the photos for biographies): Jana Hyankova Head of PV Department, IVIGEE Services a.s. Programme Please note timings may be subject to alteration. Day 1 08:30 Welcome, registration, course objectives and introduction to work groups Housekeeping notices, meet other delegates, explore how to work in your work group, course objectives. Clarify the definition and objectives of Pharmacovigilance. 09:30 The Regulatory Framework for Pharmacovigilance Identify the relevant regulations and directives. Explore GVP guidance, structure of the modules and standard format of each module. 10:00 The Pharmacovigilance System Exploration of how to organise what has to be done, communications. Exploration of the structures and processes for pharmacovigilance. 10:30 Break 11:00 Workshop 1 and Feedback Exploring an organisational model of the pharmaceutical company- cooperation between PV and other stakeholders. 12:00 The Quality System for pharmacovigilance Exploration of the structures, processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 13:00 Lunch 14:00 Workshop 2 and Feedback The quality system puzzle. Explore the organisation of the PV quality system and how it interacts with the PV system. 14:30 The Quality System for pharmacovigilance Exploration of the structures processes for the PV quality system and discussion of how it interacts with the pharmacovigilance system to meet the objectives of pharmacovigilance effectively and efficiently. 15:00 Description of PV System 15:30 Break 15:30 Workshop 3 and Feedback The quality system puzzle Explore the organisation of the PV quality system and how it interacts with the PV system. 16:00 The Pharmacovigilance Safety Master File Construction of the Pharmacovigilance System Master File and its purpose. 17:00 Workshop 3 and Feedback Description of PV System. 18:00 End of Day Day 2 08:30 Drug Safety in the Clinical Trial Environment - Part 1 Information flow and responsibilities of the sponsor. 09:30 Workshop 4 and Feedback Drug Safety in the Clinical Trial environment: Information flow and responsibilities of the sponsor. 10:30 Break 11:00 Drug Safety in the Clinical Trial Environment - Part 2 Information flow and responsibilities of the sponsor. 12:00 Lunch 13:00 Workshop 5 and Feedback Drug Safety in the clinical trial environment: Information flow and responsibilities of the sponsor. 13:30 Processing of Safety Data Exploration of safety data processing, verification, validation, follow up, formatting and collation, reporting requirements, quality and data management. 15:00 Break 15:30 EudraVigilance Exploration of how EudraVigilance supports the PV system. 16:15 Signal Detection and Evaluation/Risk Benefit Assessment: Pharmacovigilance Risk Assessment Committee (PRAC): What is a signal? What are the regulatory requirements? How is signal detection and evaluation conducted? Qualitative and quantitative methods of signal detection. Risk benefit assessment. 17:00 Risk Management Plans A cornerstone of Pharmacovigilance safety communications, direct healthcare professional communication 18:00 End of Day Day 3 08:30 The Pharmacovigilance Risk Assessment Committee (PRAC) Exploration of how good practice is achieved. Composition, role and responsibilities. Examples of referrals. 09:15 Development Safety Update Reports (DSURs): Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 10:30 Break 11:00 Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) Regulatory requirements, exploring good practice, report format, reference safety information, schedule of submission, analysis evaluations and distribution. 12:00 Workshop 6 and Feedback To explore the compilation and submission of the PSUR. 13:00 Lunch 13:30 Role of the QPPV Exploration of the legal responsibilities of the QPPV and the MAH. 14:30 Break 15:00 Workshop 7 and Feedback To explore the challenges faced by the QPPV. 15:30 End of course Extra Information Face-to-Face 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 23 Points   Development Level Develop

A System Approach to Good Pharmacovigilance Practice
Delivered In-PersonFlexible Dates
£1,297 to £1,687

Power Automate Training

By FourSquare Innovations Ltd

FourSquare Training specialise in private, corporate Power Automate courses delivered at your premises and tailored to your needs.

Power Automate Training
Delivered In-Person in Merseyside, or UK WideFlexible Dates
£1,600 to £2,000