Gain expertise in healthcare training with our Level 3 Endorsed Award in Delivering Health and Social Care Training. Our comprehensive program equips you with the skills and knowledge to become a proficient trainer in the healthcare sector.
The "Foundations of Immunisation and Vaccines for Non-Registered Practitioners" course is fully compliant with the National Minimum Standards and Core Curriculum for Immunisation Training and is designed to equip non-registered healthcare professionals with a solid understanding of immunisation concepts, vaccine administration, and the importance of vaccination in public health.
Course Information A must-have programme for Quality Assurance auditors stepping into or honing their role within a Good Laboratory Practice (GLP) environment, this course offers invaluable, expert guidance for crafting a robust and efficient GLP audit programme. What will I learn? A solid regulatory foundation underpinning quality assurance activities Clarity on the roles of Quality Assurance, management, and study director within the framework of Good Laboratory Practice principles Enhanced efficacy in inspections and audits Heightened compliance with Good Laboratory Practice standards for your facility Unique insights into governmental monitoring activities within the GLP sphere. This course is structured to encourage delegates to Discuss and develop ideas Solve specific problems Examine particular aspects of GLP. Tutors Tutors will be comprised of (click the photos for biographies): Cate Ovington Director, The Knowlogy Group Ltd Jane Elliston Senior Quality Assurance Auditor, Battelle UK Shona Ross Head of QA, Tower Mains Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:15 Good Laboratory Practice Standards and Regulations An insight into the background and history of Good Laboratory Practice. 09:45 Principles of Quality Assurance What is the role and responsibilities of QA in GLP. Maintaining the independence of QA and what is an audit. 10:30 Break 10:45 Standard Operating Procedures GLP requirements and QA involvement. 11:30 Study Plans GLP requirements and QA involvement. 12:05 QA Programme Risk based programme, what are study, process and facility audits. 13:00 Lunch 14:00 Inspections Attitudes, techniques and attributes. 14:40 Workshop 1 - Facility and Process Inspections An exercise in inspection planning and preparation for inspections. 15:15 Break 15:30 Workshop 1 - Feedback 15:45 The Auditor and Audit Conduct Attitudes, attributes and techniques. 16:30 Panel Session An opportunity for delegates to put questions to the panel of speakers. 17:15 Close of Day Day 2 09:00 Workshop 2 - A Mock Audit 10:45 Break 11:00 Workshop 2 - Feedback 11:30 Auditing the Study Report Techniques and methods for the QA audit of the study report. 12:00 Record Keeping and Data The impact of GLP on data and records management. 12:40 Lunch 13:25 Data Integrity A look at the OECD GLP guidance document; the expectations of the regulators and the involvement of QA - Where QA adds value. 14:15 Workshop 3 - Amendments to Study Plan and Deviations from the Plan What are they? What is the difference between them? How are they controlled? 15:00 Workshop 3 - Feedback 15:15 Break 15:30 Regulatory Compliance GLP Monitoring Authority monitoring for compliance with Good Laboratory Practice. 16:15 Panel Session An opportunity for delegates to put questions to the panel of speakers. 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 14 Points Development Level Learn
Course Information This course aims to empower you with the expertise to proficiently navigate process mapping and master the art of crafting Standard Operating Procedures (SOPs) within regulated environments. Whether you're engaged in activities that demand process improvement, continual enhancement, or SOP creation, this course offers invaluable insights tailored to your needs. It caters to individuals tasked with managing, documenting, and implementing processes and SOPs, irrespective of prior experience or skills. Our curriculum does not focus on specific software or approaches, focusing instead on fundamental principles and adaptable concepts applicable across diverse organisational landscapes. Benefits include: Hands-on experience in mapping processes An understanding of how process maps can be used to define, communicate and continually improve complex processes An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text An insight into the preparation of concise and user friendly SOPs. This course is structured to encourage delegates to: Discuss and develop ideas Develop a practical approach for creating process maps and writing SOPs Understand how to use process maps in SOPs effectively Discuss how process mapping for preparing SOPs can be applied to process improvement for SOPs. Is this course for you? The course is designed for all those with responsibility for managing, documenting and implementing processes and SOPs. It assumes no prior experience or skills. The course does not recommend any specific software or approach, but explores the principles and ideas that can be applied in any organisation. What will you learn? Hands-on experience in mapping processes An understanding of how process maps can be used to define, communicate and continually improve complex processes An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text An insight into the preparation of concise and user friendly SOPs. By the end of the course you will be able to: Create process maps and write clearer more concise SOPs Understand how to use process maps in SOPs effectively Understand how process mapping can be applied to process improvement and better SOPs. Tutors Tutors will be comprised of (click the photos for biographies): Laura Brown Director, Laura Brown Training and Development David Butler VP of Quality, Resolian Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome, Introductions and Course Objectives Why Companies manage by process. 10:00 Exercise 1 - First Steps Mechanisms for process mapping, levels at which it can be applied, and the roles and responsibilities of process owners. 10:30 Exercise 1 - Feedback 10:45 Break 11:00 Mapping Processes The stages involved in mapping processes including how to construct a SIPOC chart. 11:45 Exercise 2 - Mapping A Process A first opportunity to practice your new process mapping skills. 12:30 Exercise 2 - Feedback 13:00 Lunch 14:00 Exercise 3 - Discussion of Options for Format, Structure and Layout What Makes A Good SOP? Discussion of options for format, structure, level of detail of SOPs and the use of process maps for SOP writing. A case study example of a good SOP which uses a flow chart/process map. 14:45 Exercise 3 - Feedback 15:00 Break 15:15 A Case Study example of a good SOP that uses a flow chart / process map 15:30 Exercise 4 Discussion of the content of an SOP using a Process Map 15:35 Exercise 4 - Feedback 15:45 Key Writing Considerations 16:15 Exercise 5 16:45 Exercise 5 - Feedback 17:00 Close of Day Day 2 09:00 Review of Day 1 09:15 Using Metrics Selecting and using metrics to monitor and improve processes. 10:00 Exercise 6 - Practice in Process Mapping Creating Process Maps from multi-source information. 11:00 Break 11:15 Exercise 6 - Feedback 11:45 Common Pitfalls Common problems and tips for good Process Mapping. 12:15 Demonstration of Process Mapping on a PC 12:45 Lunch 13:30 Exercise 7 - Mind Mapping 14:30 Exercise 7 - Feedback 15:00 Break 15:15 Exercise 8 - Using Process Maps to Write an SOP Applying your process mapping skills as part of writing an SOP 15:30 Exercise 8 - Feedback 15:45 Course Review and Follow-up 16:00 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. Development Level Learn
Course Information Embark on our GLP course offering extensive guidance and pragmatic support tailored for individuals serving as Study Directors or Principal Investigators overseeing non-clinical safety studies on pharmaceuticals, agricultural, and industrial chemicals within the realm of Good Laboratory Practice (GLP). This comprehensive programme extends its benefits to study staff and management operating in GLP-compliant environments. The course extensively covers the current OECD GLP Principles and UK GLP legislation, while also referencing international standards, regulations, and guidelines pertinent to the field. Benefits of this course: Practical help and guidance on the interpretation and application of GLP An opportunity to update your knowledge of GLP with the current interpretation of requirements Access to an experienced panel of speakers Information on how other organisations address GLP issues An opportunity to improve your understanding of the GLP requirements as they are applied in different situations. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of GLP Learn from the experience of others. Tutors Tutors will be comprised of (click the photos for biographies): Tim Stiles Consultant, Qualogy Ltd Tony Woodall Head of Quality Assurance, Alderley Analytical Gill Armour Study Monitor Team Leader, AstraZeneca Jane Elliston Senior Quality Assurance Auditor, Battelle UK Vanessa Grant -, - Jeanet Logsted CEO, Scantox Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:15 Welcome and Introductions 09:35 Development of Good Laboratory Practice A review of the history of GLP, its current scope and application, with a synopsis of current European and international standards. 10:05 Roles and Responsibilities The responsibilities of study director, test facility, management and study staff in the conduct of a GLP study. 10:45 Break 11:00 The Roles and Responsibilities of the Study Director and Test Facility Management The role of the study director in the management and control of a study, as defined by GLP, and management's roles are explored. 11:45 Multi-site Studies What is a multi-site study and when should such concepts be applied on a study. The role of the study director and principal investigator in the planning, conduct and reporting of multi-site study are explored. 12:30 Study Plan (Protocols) GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed. 13:00 Lunch 13:45 Workshop 1 - The Study Plan Some practical problems with study plans and amendments explored. 14:45 Workshop 1 - Feedback 15:00 Standard Operating Procedures The control, content and authorisation of SOPs and the principles behind the practice. 15:30 Break 15:45 Workshop 2 - Practical Study Conduct Problems Dealing with practical problems encountered during the conduct of studies. 16:40 Workshop 2 - Feedback 17:15 Close of Day Day 2 09:00 Questions and Answers Discussion of issues raised by course delegates. 09:20 Quality Assurance The interactions between QA, management, study director and principal Investigator are discussed as is QAs role when conducting a multi-site study. 10:00 The Final Report The content of the final report and the role of those involved in its preparation and approval. Specific reporting requirements when conducting a multi-site study are also explained. 10:30 Break 10:45 Workshop 3 - Final Report Problems Practical problems of report preparation including compliance statements. 11:30 Workshop 3 - Feedback 12:00 Management of Raw Data and Records A view on how records and materials are managed and archived in compliance with GLP. 12:45 Lunch 13:30 Workshop 4 - Data and Sample Management Issues Dealing with data and sample management issues. 14:15 Workshop 4 - Feedback 14:45 Regulatory Inspection Government monitoring for compliance with Good Laboratory Practice. 15:15 Panel Session This panel session will address any outstanding issues raised by delegates. 15:45 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 14 Points Development Level Develop
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