FAA Level 1 Award In Awareness Of Safeguarding (RQF) Face-to-Face Classroom: Half-day course Virtual Classroom: 2 sessions of 2 ½ hours For those who work with children, young people and vulnerable adults Promotes awareness of safeguarding, enabling learners to identify problems and show where to report these to Course Contents: Safeguarding legislation and guidance Key safeguarding roles Different types of abuse Signs and indicators of abuse and neglect Actions to take when a safeguarding concern arises Benefits of this course: In 2018/2019, 415,050 concerns of abuse were raised In 2018/2019, there were nearly 400,000 children in need 52,300 children were subject to a child protection plan 63% of adult safeguarding concerns are for people over 65 1 in every 42 adults aged 85+ have required safeguarding enquires... Child abuse often goes unreported and unrecorded - till it is picked up on by someone who then does something about it. This Level 1 Safeguarding Awareness course gives people the knowledge to make a real difference to a person's life! This basic Safeguarding course is a nationally recognised, Ofqual regulated qualifications accredited by First Aid Awards Ltd. This means that you can be rest assured that your Level 1 in Safeguarding Certificate provides information for best practice to make a real difference to protect the health and wellbeing of the most vulnerable in our society. The Ofqual Register number for this course is 603/5635/2
Become a qualified Healthcare Support Worker in 6 months, 100% online with live interactive lessons and dedicated tutor support. Flexible payments.
Course Information This one day course is designed to provide you with comprehensive guidance and practical help for when designing and implementing audit programmes. Using the guidance of ISO 19011 with reference to PV, GCP, GMP and GLP audit programmes, you will explore audit programme design, operation, review and improvement. The course will work through why audits are important and understanding the drivers behind a good audit programme. It will discuss how to identify and assess the risks in your organisation, linking them with organisational goals, using these risks as a basis for the design of a risk-based audit programme during facilitated practical workshops. Delegates will have the opportunity to consider and discuss common issues and constraints that may shape their audit programmes. By the end of the course you will have: A clear understanding of the role of audit programmes in managing compliance and of the drivers and risks behind audit programmes An understanding of the roles and responsibilities of management and personnel An appreciation of resourcing implications and auditor attributes A good insight into the practicalities and activities required for design of risk based audit programmes A comparison of your circumstances, challenges, common issues and ways to approach managing audit programmes with other delegates on the course. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:15 Why do we Need to Audit? Exploring risk and regulation, responsibility and performance. 09:45 Discussion - Programmes, Needs, Commonalities Understanding the needs of delegates' own organisation and comparing common themes and threats. 10:00 Establishing an Audit Programme Design, objectives, risk and resources. This session discusses the consideration when designing audit programmes. 10:30 Break 10:45 Risk Management Considerations, guidance and methods for assessing and controlling risk. 11:00 Workshop 1 - Risks, Prioritisation and Control Looking at specific risks, assessing and evaluating to feed into audit programme management. 12:00 Workshop 1 - Feedback 12:30 Lunch 13:30 Putting it into Practice Resources, practicalities and challenges - the realities of auditing, including selection of auditors, ensuring practice will meet expectations and the reasons to note audit results. 13:45 Workshop 2- Designing Audit Programmes Designing audit programmes using output from risk assessment process. Challenges and flexibility. 15:00 Break 15:15 Workshop 2 - Feedback 15:30 Monitoring, Reviewing and Improving Why or when should existing processes change, understanding the implications of change or inaction and exploring how to improve the audit programme. 16:15 Panel Session This final session will address any outstanding issues raised by delegates. 16:30 Close of Course Extra Information 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 7 Points Development Level Develop
Course Information This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks. Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings. Is this course for you? Ideal for professionals engaged in GMP across various sectors, including: Research and Development (R&D) Contract Manufacturing Organisations Manufacturing Units Quality Control (QC) Laboratories Auditing Roles. What will you learn? Event objectives - by the end of the course, delegates shall: Have an awareness of the basic requirements of GMP Be aware of UK and EU GMP Rules and Guidance and relevant publications Understand the roles and responsibilities associated with GMP Be able to contribute to and maintain quality documentation Have a basic understanding of product lifecycle and manufacturing Understand the requirements of GMP in the QC laboratory context Have a basic understanding of risk management and mitigation principles Understand the need for quality systems and quality assurance activities Be aware of common regulatory findings. Learning outcomes: delegates will be able to: Implement their role within GMP with confidence and knowledge of the principle requirements Contribute effectively to the GMP quality system and their organisation’s compliance Comprehend where their organisation’s activities sit within the larger GMP arena Know where to seek further information within the published rules and guidance, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 09:30 Introductions and Scope of the Course Understand the group requirements and the tutor's background and experience. 09:45 Background and Regulatory Environment Setting the scene, understanding the context, key legislation. 10:30 Principles of GMP Key points and requirements. 11:15 Break 11:30 Personnel and Responsibilities Management and staff, duties and accountabilities. 12:00 Overview of GMP Manufacturing Basics of the product life cycle. 12:30 Lunch 13:15 Risk Management Workshop Practical exploration of risk and mitigation activities. 14:30 QC Laboratories Activities and practicalities. 15:15 Break 15:30 Compliance Quality Assurance and Self Inspection. 16:15 Question Time A chance for questions on the practicalities of GMP. 16:30 Close of Course Extra Information 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 7 Points Development Level Learn
Course Information This highly interactive course will provide guidance on why and how to implement a quality system successfully into the research laboratory. By doing so, you will position your innovation for the success it deserves. But leave things as they are and there is a good chance that your science will not realise its full potential should success, and its consequences, come your way. A quality system in your research laboratory is the most effective and efficient way to: Help scientists work more efficiently Ensure discoveries can be defended Protect the value of intellectual property. This course is particularly aimed at those working in early phase research environments which are not constrained by the regulatory requirements of the Good Practice regulations but are producing intellectual property, testing and/or products for the therapeutic market. For organisational reasons, rather than regulatory ones, this is a place where you need to get it right. The programme is delivered by leaders in the field who, quite simply, ‘have done it’. Whether delegates are at senior management level seeking strategic direction, a laboratory head wishing to deliver science that will stand the test of time or a quality professional thrown in at the deep end, this course will provide key insight and practical guidance to underpin future success. Based on risk based systems, tried and tested over many years in the workplace, the programme will help delegates to define, train, implement and monitor the quality of their research, irrespective of field or discipline. Delegates will learn how to help position their organisation for success. Course content: Delegates will be guided thoughtfully through each key component of the process in a stimulating learning environment. The course probes all avenues of the research quality arena, from an initial understanding of the cultural aspects of the scientific discovery environment, to managing quality in outsourced research programmes. Computer systems and e-data security in the research environment will be discussed and pragmatic solutions described to help manage the ballooning cloud of e-data. In addition, the ever blurring boundary between the regulated and non-regulated research environments will be discussed and delegates given perspective on future developments in the field. With this knowledge, delegates will be able to get it ‘right first time’. Is this course for you? The course is designed for all those involved in the research laboratory quality arena and it has been tailored to meet the needs of scientific management, bench scientists and quality professionals alike. Delegates get immediate access to highly experienced tutors who will share their wisdom and insights in an area where few others have been successful. The course is linked with the RQA guidance which builds on years of experience and forms the foundation of the programme. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Sandrine Bongiovanni Associate Director in Research and Quality Compliance, Novartis Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:10 Welcome and Introductions 09:20 History and Overview of the Field Examples of business and regulatory risks and the consequences of low quality in research. A look at the standards and guidelines that exist. 10:00 The Culture, the Politics and the Scientist's Perspective Understanding research environments, the drivers and the challenges. 10:30 Break 10:45 Workshop - Risk Management Thinking about risk management and prioritisation. Looking at the critical factors for the implementations of a successful quality system. 12:15 Workshop - Feedback 12:45 Lunch 13:45 Personnel, Plans, Procedures, Facilities, Equipment, Materials and Reagents Looking at planning the work, defining procedures in a way which promotes robust science without compromising brilliance and ensuring that all these elements are demonstrably fit for their intended purpose. 14:30 Workshop - Assay Validation How much validation is required at what stage? What do we need to validate an assay? 15:00 Workshop - Feedback 15:15 Research, Work Records, Archives and Research Review Data and records which are accurate, attributable, legally attestable and safe to permit reconstruction experiments and studies. Looking at aspects of the work where there is a chance to review, correct or improve the science, the data and the processes. 16:15 Continual Improvement and Quality Systems Reviewing implementation of a quality system, finding opportunities for improvement, understanding culture change. 16:45 Questions and Answers 17:00 Close of Course Extra Information 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 7 Points Development Level Develop
Course Information Join us for a comprehensive refresher focusing on crucial Good Laboratory Practice (GLP) requirements, including an emphasis on data integrity, recent developments, and emerging trends gleaned from MHRA inspections. The programme dives into specific domains such as risk assessment, OECD guidance on sponsor influence, and the advisory from OECD on QA. Additionally, delegates can benefit from a dedicated GLP clinic, facilitating discussions on understanding and upholding GLP compliance. Is this course for you? This course is tailored for study directors, principal investigators, test facility management, and QA professionals seeking to refresh their knowledge and responsibilities within the GLP framework. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Registration, Welcome and Introduction 09:20 Development of Good Laboratory Practice A reminder of the history of GLP, its current scope and application, with a synopsis of current UK, European and international standards. 09:50 Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA A reminder of the roles and responsibilities with regard to the GLP management and oversight of the Test Facility and the management and control of the study, as defined by GLP. 10:30 Break 10:45 Workshop 1 Workshop 1 Roles and responsibilities 11:15 Influence of Sponsors The published OECD Position Paper No. 21 regarding Possible Influence of Sponsors on conclusions of GLP Studies is reviewed and discussed. 11:45 Data Integrity The fundamentals of data integrity according to the OECD Guidance No. 22 on Data Integrity is discussed along with the responsibilities of Study Director, Test Facility Management, and study staff in ensuring the integrity of the GLP study data. 12:30 Lunch 13:15 Quality Assurance and GLP OECD Advisory No. 23 (Revision of OECD No.4)- A walk through of the changes to the OECD Guidance on the role and activities of Quality Assurance 13:45 Quality Improvement Tools and GLP The tools that might be considered for GLP and their role and operation when used in Test Facilities- OECD Position Paper No.24 published July 2022 14:15 Workshop 2 Workshop 2 Change control 14:30 Risk Assessment How should we assess risk and how can we use the process to assist in evaluation audit findings? 15:00 Break 15:15 Current hot topics in GLP Explore the current issues in Industry and trends /types of Regulatory inspection findings 15:50 GLP Clinic An opportunity to discuss any other issues regarding understanding and maintaining GLP Compliance. 16:30 Close of Course Extra Information 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 7 Points Development Level Learn