Being Prepared for CQC's New Assessment Framework Course
This 2-day course includes interactive classroom training and self-guided learning. Enhance your skills in managing challenging behaviors and aggression. Perfect for healthcare professionals who have previously completed a 3-5 day PMVA training. Book now! Social Media Description: 🔔 PMVA Refresher Course Alert! 🔔 📅 Duration: 2 Days (1 Day Classroom, 1 Day Self-Guided) 🏢 Location: London 👥 Who Should Attend: Healthcare professionals who have completed a 3-5 day PMVA training. 🎯 Key Learning Objectives: Refresh de-escalation techniques and physical intervention skills. Update on current local and national guidelines. Enhance personal safety and relational security. 📜 Certificate: Emailed upon completion. 📌 Topics Covered: Legal Framework PANEL Principle Relational Security Human Rights Approach Post-Incident Procedures And much more! 🌟 Enroll Today! Enhance your skills in managing challenging behaviors and ensure safety in your healthcare setting. Contact us via email, phone, or visit our website to book your place. #PMVA #HealthcareTraining #ViolencePrevention #Deescalation #ProfessionalDevelopment
With the recent pandemic, infection prevention and control has never been so important. This regulated and nationally recognised qualification provides learners with the opportunity to develop their knowledge of the principles of infection prevention and control, and how best to protect those around them. The QA Level 2 Award in Infection Prevention and Control (RQF) has been specifically designed for those who have a responsibility in infection prevention and control within their job roles, such as: care assistants, health care workers or other healthcare environments.
Supervising first aid for mental health: What will you learn? You’ll be surprised by how much you enjoy this 2-day course. I always make sure the learning process is engaging, interactive and stimulating — so you won’t be bored. Most importantly, the training course gives you a fascinating insight into a subject that’s often brushed under the carpet. This is a safe space to speak. Provided you feel comfortable to do so, there’s plenty of opportunity to open up and share your own experiences. It’s a flexible course, and I’m always happy to tailor the content. If there’s an aspect of mental health or addiction you’d like to know more about, please just ask. Here’s the course content Defining mental health, and understanding the stigma surrounding it Factors which affect mental health Roles and responsibilities of a first aider Outline of advice — What to say to someone with a suspected mental health condition Listening without judgement Knowing when to contact the emergency services Identifying signs of stress, and how stress can be managed Alcohol and drug abuse — Its effects, and the consequences for someone’s work and personal life Applying a first aid action plan How to implement a positive mental health culture in the workplace Identifying signs and symptoms of depression, suicide, psychosis, anxiety, self-harm, eating disorders, PTSD, personality disorders, bipolar and schizophrenia Do bear in mind, this course can’t teach you how to diagnose and treat a mental health condition. That’s the responsibility of a healthcare professional. However, you’ll know where to signpost an individual who needs professional help. You’ll leave with the knowledge and confidence to approach, reassure and support someone when they need it most. Group sessions (min 6 people, max 16): £245 per person
This workshop is designed to help you manage your time more effectively. It will explore issues with time management, prioritisation and delegation, managing meetings and emails, Managing other peoples priorities and action planning.
This course is for healthcare professionals who wish to understand more about vitamins . It will go through IV infusions and IM injections of Vitamins and the therapeutic effects of IV vitamin therapy.
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
For higher risk or larger workplaces/organisations such as engineering, factories, restaurants, warehousing, construction or for those who use chemicals. This is also the appropriate course for larger low risk workplaces or workplaces who have employees with medical conditions. No previous experience required HSE Compliant Certificate valid for 3 years Taught by experienced trainers Interactive & engaging delivery techniques All age groups covered (adults, children & infants) All learners will have the skills and knowledge to provide the organisation with First Aider’s that can provide treatment to their casualties in a prompt, safe and effective manner. Duration FAW Initial - 18 hours (2 days face to face + 6hrs of elearning) RFAW Requal - 12 hours (2 days face to face, with a valid previous certificate) Syllabus A range of subjects are covered including: Day 1 Role of the First Aider Primary Survey Unresponsive (Breathing) - Recovery Position & Monitoring Unresponsive (Not-Breathing) - CPR & AED Bleeding (Catesrophic, Severe & Minor) Burns Choking Seizures Shock Day 2 Fractures, dislocations and spinal injuries Poisoning Heart attacks Head injuries Chest injuries Asthma Stroke Shock Severe Allergic Reaction Eye injuries Sprains and strains Diabetes Day 3 (elearning) For those who are completing the qualification for the first time or do not have a valid existing certificate, will be required to complete elearning, which can be done before the training or within 30 days after the training. Those re-qualifying, need not complete the elearning. Assessment Continual assessment is used, combined with a number of observed practical activities and 3 short theoretical assessments, supported by our experienced trainers. Instructions Please ensure that this is shared with those who are attending the course Thank you for booking with Certifi Training, we are looking forward to having you on our course. You must bring a form of Photo ID to your training. This can be a passport, driving licence, government issued biometric card, rail card, Police Warrant Card or Official Work ID. Please arrive in good time for your training (we advise 15 mins before the start time). Late learners will not be accepted and will turned away without refund. Please wear clothing suitable for practical activities (no skirts or high heels). You must attend the entire course, learners who leave early will not be issued a certificate. Covid-19 - due to this being a healthcare course, you are prohibited from attending if you have contracted Covid-19. Practical Elements - in order to pass the course, you will be required to kneel down on the floor (primary survey), be rolled onto your side (recovery position) and perform 2 mins of rescue breaths and chest compressions (CPR). This will all have to be completed unaided. Cancellation and Postponement - our policy is found here (https://bookwhen.com/certifitraining/page/refund_policy) Injuries & Medical Conditions - if you have an injury or medical condition which would prevent you from performing practical activities, this may prevent us from being able to issue you with a qualification, please contact us if concerned. Allergies & Sensitivities - if you have an allergy or sesitivity towards hand santizers or cleaning products, please let your trainer know. Our equipment is latex free. Pregnancy - Please alert your trainer if you are or maybe pregnant. It will not stop you from being able to participate in the course, however your trainer will make a couple of adaptions during recovery position and choking activities. Reading & Writing - you must be able to read and write in English, however this can be supported by your trainer if you have a learning need (such as dyslexia) or English is your 2nd language. Certificates - certificates will be issued to the person who booked your course if you pass the course criteria. Certificates are in PDF format and will be issued within 2 weeks of the course. Elearning Certain Courses will be required to complete elearning, which can be done 30 days before or after the training, however it is beneficial if... [Read more]
The duty of care is a legal requirement and comes with the job role for any Care worker. It is part of the code of conduct for healthcare support workers and adult social care workers in England and applies as soon as someone receives treatment or care. Employees also have a duty of care to other workers.
Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 14 Points Development Level Develop