1999 Courses in Huntingdon

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

This driver CPC course Vehicle Roadworthiness & Load Safety is suitable for LGV drivers only and will cover: Requirements, Walk Around Checks, Legal Requirements, Additional Checks, Safety Equipment, Defect Reporting, Maintenance, Prohibitions, Considerations Before Loading, Overloading, Load Distribution, Load Security, Vehicle Dimensions, Loading Equipment.

This driver CPC course Vehicle Roadworthiness & Load Safety is suitable for LGV drivers only and will cover: Requirements, Walk Around Checks, Legal Requirements, Additional Checks, Safety Equipment, Defect Reporting, Maintenance, Prohibitions, Considerations Before Loading, Overloading, Load Distribution, Load Security, Vehicle Dimensions, Loading Equipment.

International Summer School for 13-18 year olds from all over the world at St Andrews, Cambridge and Yale Universities.

WHAT TYPE OF GROUP IS THIS? I provide healing to clients in a group, hosted in my studio in St Neots. These sessions were originally started in 2014, and ran for several years. I have decided to offer them again, as I feel that people need support in general. The healing rebalances the heart chakra, helps a person to feel grounded and safe, and releases tension and anxiety. These healing protocols are a small part of the full advanced frequency healing modality. Clients receive the healing seated, rather than laying flat on a couch.  This helps me to see the areas that require attention.  I have space for 4 clients in each session. This currently runs on a Sunday morning, starting at 11.00am and lasting approximately 60-90 minutes.  It is important that you wear comfortable clothing, in layers to allow for the change of temperature in my studio.  Please bring water to drink.  I have toilet facilities and parking is unrestricted along my street, though I do ask that you respect my neighbours by parking safely and keeping noise to a minimum. For you to join I will require your full name, date of birth and email.  This helps me to tune into your energy system and also send you any further information if necessary.  All your personal information is completely confidential and never shared without your permission. You can book in advance and pay online, or pay cash on the day, though I will need to speak to you if you have not attended before.   IMPORTANT INFORMATION * If you prefer to pay by cash, you can book by ringing me.  Please bring the right amount with you and please book in at least 3 days before the day you wish to attend.  * If you have booked by phone and are unable to attend, please let me know immediately so I can offer a space to someone else.  It is very important that you let me know whether you can attend or not because it helps me to run my business effectively and means that you are acting in a consistent and honest way.  * If you have booked online and cannot attend I will move you to the next session, or you can offer your slot to someone else, or I can run the session on you by distance.

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

This driver CPC course Vehicle Roadworthiness & Load Safety is suitable for LGV drivers only and will cover: Requirements, Walk Around Checks, Legal Requirements, Additional Checks, Safety Equipment, Defect Reporting, Maintenance, Prohibitions, Considerations Before Loading, Overloading, Load Distribution, Load Security, Vehicle Dimensions, Loading Equipment.

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

Sacred Sound Gong Evening at Barnwell Village Hall, Nr Oundle, Peterborough. Join Edwin and Harshani of Mind Body Wellbeing to relax, restore and feel replenished deep inside. www.mindbodywellbeing.co.uk

Discover about Tibetan Singing Bowls and how to play them, on this Strawberry Full Moon Tibetan Singing Bowl 'Play-Shop' day at the Field of Healing, Bythorn, Huntingdon ~ with Harshani and Edwin of Mind Body Wellbeing