41 Auditor courses

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

The “ISO 27001: 2013 Lead Auditor” course provides comprehensive training in the ISO 27001: 2013 standard and all its requirements from the Lead auditor’s point of view, as well as basic skills necessary to Lead audit activities. It’s a practical-oriented training that should be considered “a must” for every ISO 27001: 2013 Lead auditor.

The "ISO 14298:2021 Lead Auditor Course" integrates the principles of ISO 14298:2021, the International Standard for Security Printing Management, with the methodologies outlined in ISO 19011:2018, the Guidelines for Auditing Management Systems. The course equips participants with the skills and knowledge required to lead security printing audits effectively, ensuring compliance with ISO 14298:2021, and applies the principles of ISO 17011:2017 for conformity assessment bodies. It covers audit planning, execution, and reporting while emphasizing risk management and continual improvement.

ISO 9001 INTERNAL AUDITOR COURSE 2 DAY CLASS BASED COURSE

ISO 3834:2021 (Quality requirements for fusion welding of metallic materials) Lead Auditor” course provides comprehensive training for participants to be able to understand and audit each and every ISO 3834:2021 guidelines in ensuring orgnaisation compliance and continual improvement in the welding industry

OVERVIEW -------------------------------------------------------------------------------- This course is specially designed to enhance generic auditing skills and to attain the necessary skills as required and implementation to be a certified Internal Auditor. It is not aimed at any particular ISO Management Standard or process.  Objective * Improve their knowledge of best practices in the audit industry * Validate their proficiency and skills in audit * Differentiate themselves from their peers and create a unique advantage for themselves * Set the precedence for continued improvement and advancement * Recognise and apply the International Standards for the Professional Practice of Internal Auditing * Become a more competent professional who is knowledgeable in organizational governance

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

OVERVIEW -------------------------------------------------------------------------------- The course focuses on topics such as the fundamental concepts of auditing and quality management, principles of internal and external audit, auditing processes and tools, principles and practice of root cause analysis, communication and people skills, and other related topics. Students who successfully complete this course will gain the essential knowledge and skills necessary to become successful auditors and work with confidence to improve the processes in their organizations.

WINDOWS CERTIFICATES TRAINING COURSE DESCRIPTION A hands-on training course concentrating solely on PKI using Windows certificates. WHAT WILL YOU LEARN * Explain how PKI works. * Install windows certificates. * Configure windows certificates. * Troubleshoot windows certificates. WINDOWS CERTIFICATES TRAINING COURSE DETAILS * Who will benefit: Technical security staff. * Prerequisites: Windows server. * Duration 3 days WINDOWS CERTIFICATES TRAINING COURSE CONTENTS * PKI Symmetric encryption, asymmetric encryption, authentication, digital signing, hashing, certificates, Certification Authorities, Root CA, Intermediate CA, policy CA, Issuing CA, Certificate Revocation Lists. Hands on Inspecting a certificate. * Policies and PKI Security policy, certification policy. * CA hierarchy Impact of CAs on Active Directory, CA architecture, number of tiers, issuing CA organisation, CA configuration files. CA security. Hands on CA installation PKI health tool, monitoring. * Certificate revocation When to revoke, OCSP. Hands on Revoking certificates. * Certificate validation Discovery, validation, checks, revocation checking, certificate chains, certification publication. Hands on Event viewer. * Certificate templates Version 1, version 1, default, modifying templates. Hands on Template management. * Roles Criteria roles, CA administrator, Certificate manager, Backup operator, Auditor. Other PKI management roles. * Disaster recovery Backups, recovery. Hands on certutil. * Issuing certificates The certificate enrolment process, enrolment methods, manual enrolment, automatic enrolment. * Trust between organisations Creating Trust, CTLs, common root CA, cross certification, bridge CA. * Web servers and certificates SSL encryption, certificate authentication. Hands on Web servers. * VPN Hands on Certificate deployment for VPN. * WiFi Hands on 802.1X

COURSE DESCRIPTION Our 135hr globally recognised comprehensive lymphoedema education programme for degree level healthcare professionals working with a clinical environment. Skills and knowledge from introduction to lymphatics, assessment, and diagnosis right through to treatment and advanced management. Please note price includes VAT -------------------------------------------------------------------------------- OUR COMPREHENSIVE LYMPHOEDEMA TRAINING COURSE  Course Summary Join us on our blended learning training programme especially designed for certified healthcare professionals working within clinical settings.   By the end of the course, you will have a thorough understanding of the anatomy and physiology of the lymphatic system, enabling you to holistically assess and diagnose a patient with lymphoedema. You will be able to design and implement an appropriate research and evidence based individualised management strategy selecting from a range of therapies and new innovations. You will be competent in the field of Decongestive Lymphatic Therapy including Multi Component Bandaging (MCB) and the latest knowledge and research in Fluoroscopy Guided - Manual Lymphatic Drainage (FG-MLD®) Entry Requirements This training is suitable for: All certified healthcare professionals. Such as Medics, Registered General Nurses, Physiotherapists, Radiographers, Occupational therapists, Osteopaths and Chiropractors LEARNING FORMAT Your course is made up of a blended learning format meaning your content and modules will be taught via live interactive webinars, through self-guided independent study and face to face clinical skills workshops.   So, whether you're learning style is social, solitary, visual, kinesthetic, auditory or a combination we have a learning style to help you get the best out of the course. We hope that you make the most out of the tools that are available to you throughout the course but don't worry if you are not the most "tech-savvy", we have real people on hand to help you every step of the way. ASSESSMENT CRITERIA All students will undergo a series of course specific formative & summative assessments. Throughout the course you will be assessed through observation of practical tasks, written assessments, assignments, research and online tests. COURSE CONTENTS You will gain knowledge, skills and techniques in: * Compression * Exercise * Skincare & Wound Healing * Garments * Multi-Component Bandaging * Assessment & Treatment of Oedema * Anatomy & Pathways of the Upper & Lower Limb * FG-MLD® Technique * Tissue Dielectric Constant * Head & Neck, Midline & Genital Oedema.   Training will also cover innovations and consideration for clinical practice. Course Inclusions As part of your training pack, LTA will provide all training support materials required to undertake the course.   Such as but not limited to: * Corporate Sponsored Bandaging Pack * LymphBalls™ * Latest LTA Research & Development articles * Lymphoedema supporting literature * Access to in-house LTA training & demonstration videos * Learning management platform (CANVAS) profile & course content * Snacks & Refreshments throughout your practical skills workshops  * Dedicated support from the LTA training team Course Certification The benefits of an LTA certification means you can; * Display FG-MLD® Certified and LTA Cert. logo on your marketing material * Write LTA Cert. after your name * Wear your qualification badge * Practice MLD to further enhance outcomes * Use an innovative technique and ensure effective treatment programmes * Receive training and support from Jane Wigg & Team * Access the latest developments in Lymphoedema care * Have access to a private FG-MLD® Therapist FB Page Recertification To maintain your LTA Therapist Certification, a 2-day recertification is required after 12 months after your initial training, and you will be required to attend a 1-day recertification every 2 years thereafter to maintain your certification of practice.