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
The aim of the course is to ensure that safety requirements are appreciated by managers. To enable them to review their own safety systems. It give’s the ability to introduce new controls and possibly implement changes as appropriate to ensure safety in the workplace. Who Should Attend? The course is designed for managers and supervisors in any sector, who are required to manage health and safety risk and resources within their organisation. It is also beneficial for anybody wishing to get into the Health and Safety profession or Management. The IOSH qualification is an impressive qualification to add to a CV. Course Duration: 3 days. Learning Objectives: On successful completion of the course, delegates should be able to: Explain ‘managing safely’. Explain the component parts of a recognised safety management system such as HSG65. Identify the data and techniques required to produce an adequate record of an incident. To demonstrate the procedure for an accident investigation, recognising the human factors involved. Describe statutory requirements for reporting and procedures for checking non-reporting. Describe methods of basic trend analysis for reactive monitoring data. Define ‘hazard’ and ‘risk’, and describe the legal requirements for risk assessment. Demonstrate a practical understanding of risk assessment technique and the data required for records. Describe workplace precaution hierarchies. Prepare and use active monitoring checklists. To implement schedules for active monitoring, recording results and analysing records. Outline the main provisions of the Health and Safety at Work etc Act and the Management of Health and Safety at Work Regulations. Outline relevant health and safety legislation, codes of practice, guidance notes and information sources such as the HSE. Syllabus: 1. Module 1 – Introduction and Overview. 2. Module 2 – Risk Assessment. 3. Module 3 – Risk Control. 4. Module 4 – Health and Safety Legislation. 5. Module 5 – Common Hazards. 6. Module 6 – Investigating Accidents and Incidents. 7. Module 7 – Measuring Performance. What do IOSH Managing Safely Courses involve? The course has seven comprehensive modules. These modules cover risk assessment and control, Health and Safety Legislation, common hazards, accident and incident investigation. Also covered is performance measurement. Effectively covering all aspects of safety management in the workplace. To obtain the IOSH Managing Safely certificate, attendees will need to complete a four day course. The course is delivered using high quality animated graphics. This includes sophisticated, fun presentations to make the content of the course more memorable. With training tools including board games, DVDs and quizzes displaying clear scenarios and essential practical content. We have worked hard to ensure that taking an IOSH Managing Safely course is as enjoyable as possible. Attendees will officially attain their IOSH Managing Safely certificate upon successful completion of both the written and practical assessments of the course. Certification: An IOSH Managing Safely certificate is awarded to all those who attend the course successfully completing both written and practical assessments. Candidates will also receive an excellent workbook from IOSH, with all the tools to help them once they are back in the workplace. Understanding of the course material is evaluated by means of a 45-minute written assessment paper consisting of 20 multi-format questions. There is also a practical assessment. MHA Training was established in 2008 based at our training centre in Warrington, Cheshire. We provide an array of services On-Site also for clients around the North West in areas such as Manchester, Liverpool, Widnes, St Helens, Runcorn, Wigan, Preston and Leeds. Over the years we have expanded and have instructors available for all of our courses Nationwide. IOSH Managing Safely Refresher Course: Recently IOSH have introduced a one day refresher course. This enables candidates having previously sat a course within 3 years to keep their qualification current and upto date in just a one day course. For more information please see the factsheet below.
This workshop has been designed to help managers understand their responsibilities and what they need to do to ensure compliance with current workplace legislation - including the fire safety and CDM regulations. The day will cover the legal background - including an appreciation of how safety legislation has evolved and why; the logic behind recent developments and the implications for staff and employers; key areas of current legislation; roles and responsibilities in health and safety management, including monitoring contractors and suppliers effectively; implementing sound health and safety policies and procedures; getting staff on board, and implementing effective systems. Also, recognising potential risks and hazards and developing strategies to minimise their impact in the workplace. This course will give participants an understanding of: The broader context of the key areas of health and safety regulation which apply to your organisation Existing health and safety practice and guide them in how to shape and implement an effective health and safety policy What they should do and the procedures to support it Potential areas of risk in the workplace - and how to take action to minimise the threat to staff safety How sound health and safety processes can contribute to business performance 1 Understanding the workplace legislation Overview of health and safety and workplace legislation Compliance, the role of the facilities manager, and who is accountable? Breakout session to discuss where we are now and to highlight issues of concern Applying required policies and procedures Developing and implementation/review of the safety policy Communicating with users, clients and contractors Health and safety manual 'Selling' health and safety 2 Key legislation - a practical working guide Asbestos Regulations Construction (Design and Management) Regulations 2007 / 2015 Control of Substances Hazardous to Health (COSHH) Regulations Disability Discrimination Act (DDA) Display Screen Equipment (DSE) Regulations 1992 Electricity at Work Regulations 1989 Fire Precautions (Workplace ) Regulations 2006 Health and Safety (Consultation with Employees) Regulations 1996 Health and Safety (First Aid) Regulations 1981 Health and Safety at Work etc. Act 1974 Management of Health and Safety at Work Regulations 1992 Manual Handling Operations Regulations 1992 Portable Appliance Testing (PAT) Provision and Use of Work Equipment Regulations 1992 REACH - Registration, Evaluation, Authorisation and restriction of Chemicals Reporting of Injuries, Diseases, and Dangerous Occurrences Regulations (RIDDOR) 1995 Waste Electrical and Electronic Equipment (WEEE) Regulations 2006 Work Equipment Regulations 3 Controlling contractors Understanding the Regulations Selecting and assessing contractors Understanding and setting accountability Why a method statement? How to apply a permit to work system Safe systems of work Round-table discussion to bring out issues from participants' own experience 4 Risk assessment Understanding your hazards Identifying specialist areas How to undertake these assessments Implementation of sound systems and processes Syndicate exercise identifying where assessments are needed and carrying out assessments 5 Keeping the work environment safe Sick building syndrome and legionella Asbestos Waste management Pest control Provisions for first aid Accident reporting and investigation At-work driver safety Security 6 Fire safety Understanding the Regulatory Reform Fire Safety Order Fire certificates The fire risk assessment Testing fire-fighting equipment? Emergency procedures Workshop to examine the procedures for dealing with different types of emergencies 7 Ergonomics programme Ergonomics - important or irrelevant? Are you complying with HSE regulations? Furniture and equipment Display screen equipment assessments Homeworking - your concern or not? Syndicate exercise to review what to do when relocating or refurbishing an office 8 Inspecting and auditing Role of Health and Safety Executive Inspectors - 'be prepared' FM role Staff/trade union involvement Independent audits Records and reports Communicating the results 9 Action plan Participants to list actions they need to take after the course
Our course empowers you to handle workplace issues effectively and fairly. Learn best practices, procedures, and communication skills to maintain a harmonious and compliant workplace. Course overview Duration: 1 day (6.5 hours) This course will enable participants to manage disciplinary and grievance issues effectively. The emphasis is on the use of a structured approach where positive action and problem-solving is highlighted as a priority. The course will build knowledge, skill and confidence in handling these areas objectively, fairly and appropriately in line with policies/procedures, best practice and legal requirements. Objectives By the end of the course you will be able to: Describe the purpose of disciplinary and grievance procedures and how these relate to relevant laws and other procedures Know your role as managers in fairly and consistently applying the procedures at the informal and formal stages Explain the grounds for disciplinary or grievance action and the need to collect, assess and present evidence Describe the structure and roles of disciplinary meetings Explain of the basis for reaching fair and reasonable decisions and possible remedies and penalties Describe the grounds and procedure for appeals Content Disciplinary Procedures Employment Contract – what an employee and employer expect and how to manage when broken. Natural Justice – ensuring ‘fair play’. Misconduct v Capability - what is the difference and which process should be used to manage both. Informal v Formal Action – understanding the processes for both informal and formal disciplinary actions. Suspensions – when, why and how to suspend an employee. Investigations – how to undertake a robust investigation and what to include in the report. Disciplinary Meeting – how to conduct the meeting, the different roles involved. Appeals – understanding how people can appeal and the process to appeal. Grievance Procedures What the law requires – what are the legal requirements for handling a grievance. Informal v Formal Action – understanding the processes for both informal and formal grievance procedures. Conducting the hearing – how to undertake a robust hearing and who should be involved. Appeals - how can people appeal and what is the process.
Course Description The RQF Level 1 Awareness of Safeguarding course is designed to provide individuals with a basic understanding of safeguarding principles and practices. It aims to raise awareness about the importance of safeguarding and promote the well-being and protection of vulnerable individuals, such as children, young people, and adults at risk. The course covers the following topics: Introduction to Safeguarding: Definition and importance of safeguarding. Key legislation, policies, and guidance related to safeguarding. Roles and responsibilities of individuals and organisations in safeguarding. Types of Abuse and Neglect: Overview of different types of abuse, including physical, emotional, sexual, and financial abuse. Recognizing signs and indicators of abuse and neglect. Understanding the impact of abuse on individuals' well-being. Vulnerable Groups: Identifying vulnerable groups, such as children, young people, older adults, and individuals with disabilities or mental health issues. Understanding the specific safeguarding concerns and considerations for each group. Reporting and Responding to Safeguarding Concerns: Procedures for reporting safeguarding concerns or disclosures. Understanding the importance of maintaining confidentiality and handling sensitive information appropriately. Responding to safeguarding concerns in a timely and appropriate manner. Promoting Safeguarding and Preventing Abuse: Strategies for promoting a safe and inclusive environment. Recognizing potential risk factors and implementing preventative measures. Understanding the importance of creating a culture of safeguarding within organizations. Multi-Agency Collaboration: Collaboration between different agencies and organisations involved in safeguarding, such as social services, law enforcement, and healthcare. Sharing information and working together to ensure effective safeguarding practices. Case Studies and Scenarios: Reviewing case studies and scenarios to apply safeguarding principles and practices. Analysing potential safeguarding dilemmas and decision-making processes. Personal Responsibilities: Recognising personal boundaries and limitations when working with vulnerable individuals. Understanding the importance of self-care and managing emotional well-being when dealing with safeguarding issues. It is important to ensure that the course meets local safeguarding guidelines and requirements.
Learn the skills of a Crime Scene Investigator ... Explore the exciting world of the Forensic Investigator in this unforgettable interactive experience day. You will spend the day using real forensic methods and techniques to perform a range of established crime scene investigations. All investigations that you perform are "hands-on", giving you the opportunity to learn how these procedures work in real life. Your day will include: DRUG TESTING: Perform a drugs test! The suspect was carrying a small plastic bag of a white substance when arrested. He was known to police as a cocaine dealer. Was he carrying cocaine? Carry out chemical tests to establish if the white powder was cocaine? FINGERPRINTING: Learn how to lift and record fingerprints using the conventional dusting process to detect and preserve fingerprints. MICROSCOPY: Use a light microscope to forensically examine crime scene samples. Discover how to use different magnifying powers to optimise the results. FABRIC SAMPLE ANALYSIS: Compare samples collected at the crime scene and on the suspect to identify human hairs. SOIL ANALYSIS: Analyse soil samples collected from the crime scene and compare against soil recovered from the suspect's shoes. Identify which soil sample is common between both crime scene and suspect. Use chemical tests to confirm your results. TOOL MARK IDENTIFICATION: You have a known tool impression from the crime scene. Use forensic casting techniques to create clay impressions and compare with a range of tools recovered from the suspect's tool shed. Which tool did he use? BLOOD DETECTION: Blood-like stains were found at the crime scene. Before sending samples to the forensic lab we need to establish if they are blood samples. Use established forensic tests and procedures to identify blood spots and stains that may not be visible to the naked eye. DNA EXTRACTION: Perform an extraction procedure to extract DNA from samples provided. You will be able to see (and feel) actual DNA once you have completed the process! Awards a Certificate of Completion OPEN TO ALL APPLICANTS LOCATIONS THROUGHOUT THE U.K. AFTER THE COURSE … Understand the breadth of career opportunities available to you in nearly 100 specific disciplines of forensic science, including: Forensic Art Forensic Photography Wildlife Forensics Forensic Statistics Entomology Cypercrime and Cyper-IT Forensic Meteorology DNA analysis Counterfeiting & Forgery Casts & Impressions incl. tyres & shoes and many more! Appreciate the difference in roles between Forensic Scientist posts and Crime Scene Investigator posts. Understand that there are many forensic posts in niche areas that may benefit from existing transferrable skills (such as IT). Apply qualifications and skills acquired to parallel fields such as teaching. For a more detailed overview please see our "Opportunities in Forensic Science" guide.
About this Training Course Managing process hazards in the hydrocarbon and chemical processing industries is a critical function that requires relevant knowledge and skills due to the risks involved. The Advanced Process Safety Engineering course will discuss the interrelation of the various techniques of process safety for analysing, with a particular emphasis on engineering design aspects, as well as how to manage process hazards in a safe and effective way and how they can potentially be avoided. In this 3 full-day advanced level course, the expert course leader will provide participants with insights and examples from his career and experience to show how their learning should be applied in real-life situations. Feedback and questioning is highly encouraged. Reference material and reports can be provided to give more information on any particular topic of interest. Individual and group exercises, tutored exercises and video case studies will be provided throughout the course to underpin the key learning points. Training Objectives Upon completion of this course, participants will acquire in-depth knowledge of: Risk management and 'As Low as Reasonably Practicable' (ALARP) principles. Different aspects of process design that influence process safety. Approach to 'inherently safer' design. Defence in depth using 'layers of protection'. Process for ensuring the technical integrity of safety-critical equipment. Hazards associated with process materials. Range of hazard identification and consequence modelling techniques. Causes and mitigation of human error. Reliability and availability of safety-critical protection equipment. Role of engineered safety-critical equipment and systems. Target Audience This course is suitable for industry professionals who need to acquire a comprehensive understanding of process safety. This includes those who are required to make managerial decisions where process safety is a key consideration, those who are moving into process safety positions or those who wish to broaden their process safety knowledge within their existing discipline. It is particularly suited for anyone involved in the design, operation, modification or maintenance of a major hazard installation, and will demonstrate a substantial understanding of process safety for those engaged in Continuous Professional Development or aiming for Chartered Engineer status. This course will benefit professionals such as: Operations and maintenance supervisors Process, mechanical and chemical engineers and technicians Design engineers, project engineers and HSE managers Control, automation and instrumentation engineers Course Level Advanced Trainer Your expert course leader has 50 years' experience in chemical and process safety engineering. His early career included 20 years in design and project engineering with various fine chemical and pharmaceutical companies where he designed chemical processes, specified plant equipment and selected materials for highly corrosive and toxic processes, often where textbook data was not available. This was followed by 10 years in offshore oil and gas design projects where he was responsible for setting up a Technical Safety group to change design safety practices in the aftermath of the 1988 Piper Alpha disaster. In recent years, he has been called upon to conduct various offshore and onshore incident investigations. His career has given him experience in project engineering, project management, process design and operations, safety engineering and risk management. He is a Fellow of the UK Institution of Chemical Engineers. He served on the Scottish Branch committee, and was elected chairman for a two-year term in 1991. He has also been chairman of the Safety and Reliability Society - North of Scotland Branch. He has delivered training courses in Process Hazard Analysis (HAZOP and HAZID), Process Safety Management, Hazard Awareness, Risk Assessment, Root Cause Analysis, Failure Modes & Effect Analysis and has lectured on Reliability Analysis to the M.Sc. course in Process Safety and Loss Prevention at Sheffield University. In addition to delivering training courses, he currently facilitates HAZOP / HAZID / LOPA studies and undertakes expert witness roles advising lawyers engaged in contractual disputes, usually involving the design or construction of chemical plants or Oil & Gas production facilities, or criminal prosecutions. 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
Gain expertise in process safety management engineering through EnergyEdge's course. Participate in our classroom training to enhance your skills and knowledge.
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