1776 Courses

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

This one day course has been developed to teach essential real estate financial modelling theory, functions and formulas to individuals working in the real estate sector.

Discover the key to safety and efficiency in offshore operations for oil, gas, and wind sectors with EnergyEdge's course on marine operations and HSE management.

QSIG training course description A concise overview of QSIG, covering the development, current use and future of this private network signalling protocol. What will you learn Describe the use of QSIG. Describe the evolution of QSIG. Describe functionality of the QSIGProtocol Stack. Describe functionality and use of the main Supplementary Services and Additional Network Functions within QSIG. QSIG training course details Who will benefit: Network/Systems Engineers Operators/Planners or anyone working within the QSIG Arena. Prerequisites: Telecommunications Introduction Duration 1 day QSIG training course contents Introduction What is QSIG? User benefits, flexible interconnection, public ISDN synergy, feature transparency-end to end intelligence, innovation specialist features - heterogeneous environment. Evolution of QSIG Evolution of QSIG, ISDN PBX Networking, Specification forum (IPNS), QSIG standardisation. The ITU-T reference model extended for corporate networks. QSIG Protocol Q Protocol stack, QSIG basic call layer 3 - SubLayer 1, QSIG Generic Functional layer 3 Sub-Layer 2 (GF), QSIG protocols for supplementary services & ANF's- Layer 3, Sub-Layer 3, Layer 3 Message Overview. Supplementary Services and ANFs QSIG supplementary services standardisation methodology. QSIG Services and additional network features: Advice of charge, Call Completion, (CCBS, CCNR), Call Forwarding and diversion (CFB, CFNR, CFU, CD), Services (CINT, CI, CO, CT, CW, DDI) Services cont. (DND, DNDO), Identification Services - (CLIP, COLP, CLIR, CNIP, CONP, CNIR), Other QSIG services and additional network features (Mobile, Multi Subscriber Number (MSN), Operator Services, Recall (RE), Sub-Addressing (SUB)), User to user signalling, compliance with services. Conclusion - QSIG1 FAQ's, European Computer Manufacturers Association. The Future.

QA Level 2 Award In Food Safety For Retail (RQF) Face to Face: Full day course Virtual Classroom: Spread over 3 sessions of 2½ hr duration Food business operators are required by law, to ensure that food handlers receive appropriate supervision and instruction/training in food hygiene in line with their work activity and should enable them to handle food safely Recommended by HSE and Environmental Health Officers (EHO's) Course Contents: The Importance of Food Safety Food Safety Laws Legal Responsibilities of Food Handlers Types of Contamination and the Associated Risks Bacteriology Food Poisoning Foodborne Illnesses An Introduction to Hazard Analysis and Critical Control Points (HACCP) Personal Hygiene Work Flow, Work Surfaces and Equipment Cleaning and Disinfection Waste Disposal Pest Control Safe Food Handling Practices including Time and Temperature Controls Preparation Cooking and Reheating Chilling Cooling Thawing Hot holding Displaying food Core temperatures Food Preservation Storage Stock Control Procedures Benefits of this course: Businesses have a duty to their customers to produce food that is safe for consumption. There are one million cases of food poisoning in the UK each year. More than 6,000 are admitted to hospital. In 2014/2015, businesses in Chesterfield were issued 344 written enforcement notices. Derby received 1,116. Doing our Ofqual regulated, nationally accredited course ensures that nothing of importance is left out. EU and UK regulations state that all food handlers must receive appropriate training in food safety practices relevant to their duties. The Food Standards Agency says that 'Food business operators are required by law, to ensure that food handlers receive appropriate supervision and instruction/training in food hygiene in line with their work activity and should enable them to handle food safely’. Our QA Level 2 Award in Food Safety in Catering (RQF) is a nationally accredited qualification especially suitable for people working in, or planning to work in, the food retail industry, and complies with the training regulations.

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

SNMP training course description A hands-on generic look at the technical operation of SNMP. The course starts with an overview of all the components, which make up SNMP. Hands on starts early with configuration of a managed network. The major versions of SNMP are then put into perspective followed by a look at the SNMP protocol. MIBs are then studied both from the perspective of reading MIBs and writing MIBs. The course finishes with a look at the security implications of SNMP. What will you learn Describe the SNMP architecture. Analyse SNMP packets. Recognise the MIB structure. Describe the SMI. Recognise the strengths and weaknesses of SNMPv2 and SNMPv3. SNMP training course details Who will benefit: Network administrators. Network operators. Programmers writing MIBs and agents. Prerequisites: TCP/IP Foundation for engineers Hands on experience of an SNMP management station would also be beneficial. Duration 3 days SNMP training course contents Network management What is network management? Benefits, issues. What is SNMP? SNMP architecture, SNMP MIBs, SMI, the SNMP protocol, polling security, alternatives to SNMP: CMIP, web based management. Configuring SNMP Auto discovery for management stations, NMS configuration, agent configuration, traps. Hands on Configuring agents and an NMS. SNMP background SNMP history, RFCs, standards, SNMP protocol versions, SNMPv1, SNMPv2, SNMPv3, SNMP SMI versions, which version should you use? Futures. SNMPv1 packets SNMP in the 7 layer model, port numbers, general packet format, BER, GET, GET-NEXT, tables, SET, TRAP, bandwidth issues, in band versus out of band management. Hands on Analysing SNMPv1 packets. SNMPv2 packets SNMPv2 improvements, error handling, GETBULK, v2traps, INFORM. Hands on Analysing SNMPv2 packets. SNMPv3 packets SNMPv3 packet format, use of SNMPv2 messages, REPORT PDU. MIB structure The internet MIB branch, standard mib-2, extra parts of mib-2, private enterprise MIBs, loading extra MIBs. Hands on MIB browsing. mib-2 The mib-2 groups, system group, interfaces group, IP group, ICMP group, TCP group, UDP group, transmission group, SNMP group, RMON. Hands on mib-2 browsing in detail. SMI The MIB layout, obtaining a private enterprise number, MIB definitions, IMPORT, Module identity, Textual conventions, object definitions, notifications, compliance statements, object groups, base SMI data types, application data types, scalars, instances, tables, table definition, writing agents, SMIng. SNMP security Community strings, SNMPv1 and SNMPv2c security practices, SNMPv3 security, SNMPv3 architecture, SNMP applications, the SNMP engine, the EngineID, security fields in SNMPv3 packets, USM, authentication, encryption, timeliness, VBAC, SNMPv3 configuration.

This training is ideal for designated first responders in smaller, low-risk business environments. You'll learn how to administer emergency first aid to adult casualties. With this training, you'll be able to deliver vital care when it's most required. Don't put it off until it's too late – enrol in our Emergency First Aid at Work Course now!. Emergencies can happen without warning, and CPR certification is essential to be prepared. With our EFAW Course in Norfolk, you'll be equipped to handle any emergency situation. This CPR training is perfect for designated first responders in smaller, low-risk business settings. You'll gain the skills needed to administer CPR and emergency first aid to adult victims. Acquiring a CPR certification ensures that you can provide crucial care when it's most needed

Experience safer urban roads with our FORS Approved Virtual Reality Safe Urban Driving Training. Our immersive program empowers drivers to navigate bustling city streets alongside vulnerable road users, fostering a culture of road safety. With a seven-hour DCPC-approved course, participants gain valuable insights and skills for responsible driving. Invest in your drivers' safety and meet compliance requirements while protecting lives on the road. Elevate road safety with our innovative VR training. Learn more at www.totalcompliance.co.uk

On this course, we will use case studies to enhance the delegates understanding of Real Estate financial appraisals, and help them fully appreciate the theory behind the numbers.