This half day course looks at practical methods of saving time and prioritising work so that participants are more productive. It considers a wide range of strategies to overcome some of the physical and mental barriers for those working in an office or home environment.
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
About this Training Course This intensive 5 full-day has been designed as a separately bookable course comprising 3 days of Well Integrity (Basic) and 2 days of Advanced Well Integrity. The intensive 3 full-day course will equip the participants with a thorough knowledge of well integrity management and risk assessment in producing assets. Based on the regulatory requirements and using real examples and exercises from around the world, this represents best practice integrity management within the oil and gas industry. When to take action with a well is a critical decision, both from a safety and economic perspective. A consistent approach to decision-making provides certainty within the organisation, focusing effort, and spending wisely. The decision-making steps will be set out to ensure all critical aspects are captured consistently. Risk analysis approaches used by different organisations and examples of risk management and risk-ranking methods will be discussed. The 2 full-day course will deepen the participants' knowledge of well integrity management, and skills for designing, operating, and maintaining well equipment. The ultimate goal is to optimise productivity at the lowest Unit Operating Cost (UOC) and to maintain mechanical integrity throughout well life cycle. Well Integrity management is looked at in three distinct stages. The first stage is during the well design which includes material selection, engineering design, cement design, coating and inhibitors and cathodic protection. The second stage is monitoring the well during the life of the well, locating possible leaks and / or loss of metal. The last stage is to manage and control any well integrity issues using specialised products, services and techniques. Training Objectives 1. Well Integrity Training: Upon completion of this course, the participants will be able to: Define the building blocks of a successful well integrity management system Develop an approach to risk management, understand risk analysis and methods applied across the industry How do we 'Make Wells Safer', learn about emerging technologies for well integrity problem diagnosis and new techniques available to 'repair' the issues Execute the basic elements of well integrity management training for field operators Evaluate well design elements that enhance or hinder well integrity status definition during the operating phase of the well life-cycle Gain the demonstrable benefits of well integrity management from field experience Review cases studies and discuss them to enhance knowledge and take on board lessons learned 2. Advanced Well Integrity: Define well integrity well categorization based on compliance to the barrier policy outlined in the regulations and develop an approach to risk management Discuss well-completion design and construction to create a 'integer' well with the lowest life cycle maintenance cost from a WIM perspective Monitoring and surveillance of well integrity, focusing on barrier competence such as cementing and corrosion Investigate and manage well integrity issues, causes & potential solutions Understand repairs needed to address 'Loss of Well Operating Envelope' Gain an overview understanding of Well Suspension & Well Abandonment Discuss further case studies as well as conduct a post course test Target Audience Invaluable for production, operations, and integrity professionals involved in implementing & managing well integrity and seeking to improve performance. It is also essential for those who need to develop and implement such systems, or who have a general need to know and understand more about well integrity management. The course will also provide a fresh approach for senior professionals and managers. Designed for professionals in the oil and gas industry who are involved in the design, construction and operation of wells from the following disciplines: Production Maintenance Production Operations Drilling Engineering Safety engineering Well Intervention Well Integrity Engineering Asset Management Course Level Intermediate Advanced Trainer Gordon Duncan has over 40 years of experience in the Oil & Gas industry. During that time, he has worked exclusively in well intervention and completions. After a number of years working for intervention service companies (completions, slickline & workovers), he joined Shell as a well service supervisor. He was responsible for the day-to-day supervision of all well intervention work on Shell's Persian/Arabian Gulf platforms. This included completion running, coil tubing, e-line, slickline, hydraulic workovers, well testing and stimulation operations. An office-based role as a senior well engineer followed. He was responsible for planning, programming and organising of all the well engineering and intervention work on a number of fields in the Middle East. He had a brief spell as a Site Representative for Santos in Australia before joining Petro-Canada as Completions Superintendent in Syria, then moved to Australia as Completions Operations Superintendent for Santos, before returning to Shell as Field Supervisor Completions and Well Interventions in Iraq where he carried out the first ever formal abandonment of a well in the Majnoon Field. While working on rotation, he regularly taught Completion Practices, Well Intervention, Well Integrity and Reporting & Planning courses all over the world. In 2014, he started to focus 100% on training and became the Technical Director for PetroEDGE. Since commencing delivering training courses in 2008, he has taught over 300 courses in 31 cities in 16 countries to in excess of 3,500 participants. POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations
The QA Level 3 Award in Administering Emergency Oxygen (RQF) qualification has been designed for those who are responsible for providing care to casualties where the administration of emergency oxygen may be required. Over a half day period, candidates will learn about the clinical need for emergency oxygen and the safety considerations of this, as well as how to administer emergency oxygen when dealing with a range of conditions. Successful candidates will leave the course with the knowledge and skills needed to administer emergency oxygen both safely and effectively. Achievement of this qualification confirms candidates have met both the theoretical and practical requirements, however, it does not imply a ‘license to practice’ – the scope of practice is determined by the organisation responsible for oxygen provision. This qualification does not allow candidates to obtain, store or administer oxygen without clinical governance.
Overview This one day Accident Investigation course will give participants the necessary information and skills to enable them to carry out a thorough and effective accident investigation. Description This course will provide attendees with the necessary information and skills, to reach the right conclusions, make effective, practical recommendations and thereby make a significant contribution to improving workplace health and safety. Topics covered: Accidents & Accident Causation – If an organisation does not properly control risks, the outcome of an accident often depends on chance. Because the outcome of an accident cannot be accurately predicted, the only way to effectively reduce accidents is by controlling the underlying causes of all the different accident types. Accident Reporting Process – Reporting of Injuries, Diseases & Dangerous Occurrences Regulations 1995 (RIDDOR) The Process – You have 2 top priorities when you are first notified of an accident. The first is to the injured person to ensure that appropriate medical attention is available. The second priority is then to ensure that the area is made safe to ensure no other persons are injured Accident Investigation – Every employer has a Moral, Legal & Economic obligation to protect the health and safety of employees while at work The Cause of Accidents – During an accident investigation you will be looking for the unsafe acts and the unsafe conditions which contributed to the accident. If you carry out the investigation effectively, then you will find the root cause or causes of the accident Facts to be Collated – When you conduct an accident investigation you should be seeking to obtain information on unsafe acts, unsafe conditions, immediate failures and latent failures. To find out these various elements of the accident you need to ask the questions who, where, when, and what, which will give you details of the event Reaching Conclusion – Identifying all the failure modes, satisfy all the answers to what, where, why, who etc., and thus identify all the causes of the accident Review of Session – Creating an action plan to embed learning. Who should attend Managers, leaders, trainers, health and safety officers and anyone involved in health and safety training and/or procedures. Requirements for Attendees None.
Level 2 NVQ Diploma in Drilling Operations - Land Drilling - Lead Driller
The Gold Card Training Programme is the most comprehensive electrician course available. We offer weekday, weekend and evening delivery options. JIB ECS (Gold) Card is quickly becoming a necessity when seeking work on commercial sites, or sub-contracting to larger contractors.