285 Medicine & Nursing courses in Soham

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

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

COURSE INFORMATION Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process. EXTENDING EXPERTISE: Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning. RELEVANCE AND VALUE: Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course.  KEY BENEFITS: ENRICH YOUR SKILL SET TO: * Navigate audit processes encompassing planning, execution, reporting, and follow-up * Embrace a personalised approach fostering positive audit outcomes * Analyse evidence and present cohesive audit findings * Recognise the pivotal role of audits in driving continual improvement. INTERACTIVE LEARNING: Structured to foster dynamic engagement, this course encourages delegates to: * Engage in discussions, idea development, and problem-solving * Exchange invaluable information and experiences. HANDS-ON EXPERIENCE: A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios. -------------------------------------------------------------------------------- TUTORS Tutors will be comprised of (click the photos for biographies): ANDREW WADDELL Founder Director, Tower Mains Ltd ROSEMARY ICHABA Senior QA Associate, Tower Mains Ltd CATE OVINGTON Director, The Knowlogy Group Ltd JEAN MCWILLIAM Associate Director, Alexion View pop up [https://www.therqa.com/learn-develop-connect/courses-and-events/events/course/the-auditing-course/#] -------------------------------------------------------------------------------- PROGRAMME Please note timings may be subject to alteration. DAY 1 08:45 REGISTRATION 09:00 WELCOME AND COURSE OBJECTIVES 09:10 WHAT IS 'AUDIT'? Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements. 09:30 AUDITS AND THEIR PURPOSE The concepts of quality assurance, quality control, quality management and audit are discussed. 10:30 BREAK 10:45 AUDIT PLANNING The requirements for an effective audit programme and individual audit plans. 11:30 WORKSHOP 1 - GETTING THE AUDIT STARTED Planning for the audit. 12:25 WORKSHOP 1 - FEEDBACK 12:45 LUNCH 13:30 WORKSHOP 2 - GETTING THE AUDIT STARTED Arranging the opening meeting. 13:50 WORKSHOP 2 - FEEDBACK Audit initiation. Review and discussion of the role of the opening meeting. 14:25 AUDITING TECHNIQUES (1) - DATA AND DOCUMENTATION Techniques for the conduct of data and report audits are investigated. 14:55 BREAK 15:10 WORKSHOP 3 - DATA AND DOCUMENTATION AUDIT Conducting an audit of a data package and supporting documentation. 17:15 CLOSE OF DAY DAY 2 09:00 AUDITING TECHNIQUES (2) - THE PEOPLE Questioning techniques which get the required information from the auditee. 09:45 LIVE AUDIT ROLE PLAY Auditor and auditee behaviours are explored and strategies developed for successful audit interactions. 10:15 BREAK 10:35 AUDIT CLOSING MEETING An exploration of audit closing meetings. 11:00 WORKSHOP 4 - AUDIT OBSERVATIONS AND PREPARING FOR THE CLOSING MEETING Reviewing and categorising your observations and getting ready to present your case. 11:45 WORKSHOP 4 - FEEDBACK 12:30 AUDIT REPORTS The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed. 13:00 LUNCH 13:45 WORKSHOP 5 - AUDIT REPORTS AND FOLLOW-UP Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example. 14:30 WORKSHOP 5 - FEEDBACK 14:55 CORRECTIVE AND PREVENTIVE ACTION AND FOLLOW-UP The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored. 15:20 PANEL SESSION An opportunity to get answers to outstanding questions. 15:30 CLOSE OF COURSE -------------------------------------------------------------------------------- EXTRA INFORMATION 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. CPD POINTS 14 Points   DEVELOPMENT LEVEL Develop

Gain advanced knowledge and practical skills in instructing buccal midazolam administration for epilepsy with our Level 4 Award course.

Enhance your clinical expertise with our "Extended Clinical Skills Training" course. Designed for healthcare professionals, this course provides practical skills and knowledge for extended clinical procedures and interventions.

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

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