69 Auditor courses

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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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Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 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 19 Points Development Level Develop

IP security training course description Connection to the Internet is becoming an essential business tool. This course looks at firewalls, digital certificates, encryption and other essential topics for e-commerce sites. A generic course that looks at firewalls and VPNs. Hands on sessions include using hacking tools and configuring firewalls. What will you learn Describe: Basic security attacks RADIUS SSL IPSec VPNs Implement digital certificates Deploy firewalls to protect Web servers and users. Secure Web servers and clients. IP security training course details Who will benefit: Network administrators. Network operators. Security auditors Prerequisites: TCP/IP foundation for engineers Duration 2 days IP security training course contents TCP/IP review Brief overview of the relevant headers. Hands on Download software for course, use analyser to capture passwords on the wire. Security review Policies, Types of security breach, denial of service, data manipulation, data theft, data destruction, security checklists, incident response. Security exploits The Internet worm, IP spoofing, SYN attack, hijacking, Ping o' Death… keeping up to date with new threats. Hands on Use a port scanning tool, use a 'hacking' tool. Firewalls Products, Packet filtering, DMZ, content filtering, stateful packet inspection, Proxies, firewall architectures, Intrusion Detection Systems, Viruses. Hands on Set up a firewall and prevent attacks. NAT NAT and PAT, Why use NAT, NAT-ALG, RSIP. Encryption Encryption keys, Encryption strengths, Secret key vs Public key, algorithms, systems, SSL, SSH, Public Key Infrastructures. Hands on Run a password-cracking program. Authentication Types of authentication, Securid, Biometrics, PGP, Digital certificates, X.509 v3, Certificate authorities, CRLs, PPP authentication, RADIUS. Hands on Using certificates. Web client and server security Cookies, browser certificates, censorship, PICS. Operating system security, Web server user authentication, Restricting access, Logging, Securing CGI scripts. Hands on Browser security. VPNs and IPSec What is a VPN, tunnelling, L2F, PPTP, L2TP, IPSec, AH, ESP, transport mode, tunnel mode.

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About this VILT Tripod can be used in any area of business where the organisation has a management system in place to prevent unwanted events e.g., health, safety, environment, quality, security, productivity, project management, and many more Tripod Beta is one of several tools based on Tripod's fundamental principles. Tripod Beta is based on proven theories, man years of academic research, and testing in the workplace. The Swiss Cheese Model originated from this work. Features of the methodology are: 1) the Tripod Beta diagram; it provides an easy-to-read summary of the entire investigation on a single page, 2) it accommodates deficiencies in leadership and worker participation, 3) it accommodates deficiencies in human behaviour, and 4) it highlights missing controls (not just controls that failed). Quality throughout all aspects of Tripod is assured by the Stichting Tripod Foundation (STF) and the Energy Institute. The participants will gain a theoretical understanding of the Tripod Beta methodology and terminology. They will be able to read Tripod diagrams and reports, and be able to assist incident investigation/analysis as a team member. This is the first step to becoming an accredited silver or gold practitioner. Tripod Beta Practitioner Accreditation is meant to build these skills, through a blend of support, coaching and assessments. Feedback is provided on Tripod incident investigation reports, giving the Practitioner the opportunity to hone their skills and become confident in their ability to use Tripod effectively. Training Objectives Upon completion of this course, participants will be able to: Pass the Tripod Beta Practitioner (Bronze Level) exam Act as a team member or Tripod facilitator on an incident investigation Plan and schedule activities for an incident investigation Focus line of enquiry during an investigation Engage with the most relevant people at each stage of the investigation Describe the incident causation paths in terms that align with their management system Consider issues relating to leadership, worker participation and human behaviour Assess the quality of an incident report Apply the process to any type of unwanted event that should have been prevented by a management system e.g., health, safety, environment, financial, security, productivity, quality, project management etc. Combine the findings from many incidents with data from other initiatives e.g., audits and inspections, to spot trends to prioritise actions and product a single improvement plan Target Audience The course is recommended for anyone who is expected to play a role in designing, reviewing, auditing, and following your organizations OH&S management system. Successful participants will be awarded the Stitching Tripod Foundation Tripod Beta Bronze certificate. The following oil & gas company personnel will benefit from the knowledge shared in this course: CEO Team Leaders Legal, insurance and finance departments Managers (Line and Function) Maintenance Engineers Quality Assurance Engineers Process Engineers Incident Investigators (Team member & Tripod facilitator) Project Managers System Custodians Technical Authorities Key Contractor's Management Contract Managers/Holders Safety Representatives Risk Management Engineers HSE Advisors Supervisors Auditors Regulators Course Level Basic or Foundation Trainer Your expert course leader has over 30 years of experience in construction, operations and maintenance with the upstream exploration and production sector. He joined Shell International E&P in 1971 and for 28 years worked in several locations around the world. Following the Piper Alpha incident he led Shell's two year, £10M major overhaul of their permit to work system. He first made use of the Tripod Beta principles during this period and since then he has delivered over 100 Tripod Beta courses in more than 25 locations around the world. He is a Chartered Engineer, a member of the Institution of Engineering and Technology and holds a postgraduate diploma from the University of Birmingham (UK). POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations

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Discover the key to safety and efficiency in offshore operations for oil, gas, and wind sectors with EnergyEdge's course on marine operations and HSE management.