53 Quality Assurance 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

This very practical one-day programme provides participants with the skills and knowledge required to be an effective member of the procurement team and to enable them to procure a wide range of resources for the organisation, in a compliant and cost-effective manner. It also empowers them to be able to collaborate with all key stakeholders. By the end of the programme participants will be able to: Understand the basic concepts of good procurement practice Apply a range of tools and techniques for developing scopes of work and specifications Apply various methods to select and evaluate suppliers Develop robust contract award strategies Appreciate the commercial importance of effective procurement and opportunities to reduce cost and add value Develop appropriate procurement strategies depending on risk and value Appreciate the legal aspects of procurement 1 Welcome Introductions Aims and objectives Plan for the day 2 The basics of procurement The concept of total cost of ownership v price The procurement cycle The roles of the customer and the contractor Impact upon profit 3 Specification process Importance of effective specifications Specification development process Types of specification Team approach Use of performance specifications Early supplier involvement (ESI) / early contractor involvement (ECI) 4 Quality Concepts and practices Defining 'fit for purpose' Conformance to requirements Compliance to standards Role of the supplier Quality assurance tools and techniques 5 Procurement methods RFP RFQ ITT Negotiated procurement Strategic partnerships Outsourcing 6 Tendering How to undertake a formal tendering process Business case to award Critical stages in the process Risks and benefits 7 Tender evaluation How to undertake a quotation analysis Tools of analysis Use of VFM models Role of the customer Comparisons around cost, quality, and delivery 8 Supplier selection and evaluation Developing critical selection criteria Using the 10Cs model Importance of effective selection process Weighting systems Importance of validity and evidence 9 Capital equipment procurement Life cycle cost issues Payback calculations Compatibility issues Maintenance and training issues After-sales support 10 Supplier relationships Corporate social responsibility issues Communication 360 feed-back Open and ethical Initial understanding Clear and fair terms and conditions 11 Close Review of key learning points Personal action planning

PRINCE2® Foundation and Practitioner are process-based project management approaches that can be easily customised and scaled. PRINCE2® Foundation and Practitioner course aim to provide delegates with a comprehensive knowledge of project management methodologies. Course Overview PRINCE2 Foundation and Practitioner are process-based project management approaches that can be easily customised and scaled. PRINCE2® Foundation and Practitioner course aim to provide delegates with a comprehensive knowledge of project management methodologies. At the end of this PRINCE2® Foundation and Practitioner course, delegates will be able to delegate tolerances and report actual and forecast progress effectively. They will also be able to quickly prepare the risk management, change control, quality management, and communication management approaches. Attaining this PRINCE2® certification enables candidates to demonstrate and enhance their project management proficiency – contributing to elevated business acumen and career prospects. Concepts covered: • Project management • Levels of management • Authorise initiation • Tailoring the IP process • Project and stage plans • Analysing risks to a plan • Escalate issues and risks PRINCE2® Foundation Training: This introductory PRINCE2® certification will help candidates understand the fundamentals of the PRINCE2® project management methodology and develop an appreciation of the constituents that contribute to a project’s success – underpinned by the PRINCE2® principles, processes, and themes. The foundation element of the combined course lasts for 3 days. During the course, candidates will gain a basic understanding of how to work in part of a PRINCE2® team. PRINCE2® Practitioner Training: The PRINCE2® Practitioner element of the combined course forms the final part of the training where the candidate learns to apply their acquired knowledge. Candidates will be educated on how to apply the methodology to a set of scenarios and how to efficaciously lead a project. What’s Included in this PRINCE2® Course? The following is included in this PRINCE2® Course: • The PRINCE2® Foundation Examination • The PRINCE2® Practitioner Examination • Pre-course material • PRINCE2® Workbook • PDUs • Experienced PRINCE2® Instructor • Certificate • Refreshments • PRINCE2 Homework – Set by your PRINCE2 Instructor at the end of each day. Prerequisites for PRINCE2® Course: In this PRINCE2® Foundation and Practitioner course, there are no formal prerequisites. This PRINCE2® Course is designed for anyone who wants to gain in-depth knowledge about project management methodologies. This Course is more beneficial for: • Project Managers • Aspiring Project Managers • Team Leaders • Directors • Senior Responsible Owners PRINCE2® Foundation and Practitioner 6th Edition Training Course Outline: Module 1: Introduction to Projects and the PRINCE2® Methodology: • PRINCE2® “Project” Definition • Project Characteristics • Project Management • What is PRINCE2®? • Four Integrated Elements • What PRINCE2® Does Not Provide • What Makes a Project a PRINCE2® Project? Module 2: Project Manager Activities: • Customer/Supplier Environment • Projects in Context • Commercial Environment • Applying PRINCE2® • Delivery Approaches • Measuring Success • Organisational Capability • Seven Processes Module 3: Seven Themes: • Business Case • Organisation • Quality • Plans • Risk • Change • Progress Module 4: Seven Principles: • Continued Business Justification • Learn from Experience • Defined Roles and Responsibilities • Manage by Stages • Manage by Exception • Focus on Products • Tailor to Suit the Project Module 5: Organisation Theme: • Four Levels of Management • PRINCE2® Organisation Requirements • Project Management Team • Project Management Team Roles • Project Board • Project Assurance • Change Authority • Project Support • Communication Management Approach Module 6: Starting Up a Project (SU): • Process Overview • Feasibility Study and Mandate • Appoint the Executive and the Project Manager • Capture Previous Lessons • Design and Appoint the Project Management Team • Prepare the Outline Business Case • Project Product Description • Select the Project Approach and Assemble the Project Brief • Plan the Initiation Stage • Tailoring the SU Process Module 7: Directing a Project (DP): • Authorise Initiation • Authorise the Project • Authorise a Stage or Exception Plan • Authorise Project Closure • Give Ad Hoc Direction • Tailoring the DP Process • Theme Overview • Balance of Justification • Continued Business Justification • PRINCE2® Requirements • Contents of a Business Case • Business Case Development • Benefits Management Approach • Key Responsibilities Module 8: Initiating a Project (IP): • Agree to the Tailoring Requirements • Prepare the Risk Management Approach • Prepare the Change Control Approach • Prepare the Quality Management Approach • Prepare the Communication Management Approach • Set up the Project Controls • Create the Project Plan • Prepare the Benefits Management Approach • Assemble the Project Initiation Documentation • Tailoring the IP Process Module 9: Risk Theme: • Risk Definition • Effective Risk Management • PRINCE2® Risk Requirements • Risk Management Approach • Probability/Impact Grid • Risk Register • Risk Management Procedure • Identify Step • Risk Budget • Key Responsibilities Module 10: Quality Theme: • Quality Definitions • Quality Management • Quality Planning and Control • What is Quality Assurance? • PRINCE2® Quality Requirements • PRINCE2® Quality Documentation Requirements • Quality Management Approach • Quality Audit Trail • Project Product Description • Product Description • Quality Review Technique • Quality Review Roles/Responsibilities • Quality Review Meeting • Off-Specifications and Concessions • Review Follow-Up • Quality Review Benefits • Key Responsibilities • Communication Management Approach Module 11: Plans Theme: • Dealing with the Planning Horizon • PRINCE2® Planning Requirements • Documentation Requirements • Project and Stage Plans • Team Plans and Work Packages • Plans Relationship • What is in a Plan? • PRINCE2® Approach to Plans • Designing a Plan • Delivery Approaches • Defining and Analysing the Products • Product Breakdown Structures • Product Description • Product Flow Diagram • Identify the Activities and Dependencies • Preparing Estimates • Preparing a Schedule • Documenting the Plan • Analysing Risks to a Plan • Gantt Chart and Tailoring • Key Responsibilities Module 12: Progress Theme: • Progress Definition • PRINCE2® Requirements • Progress Control • Management by Exception • Delegating Tolerances and Reporting Actual and Forecast Progress • Types of Control • Management Products and Progress Control Module 13: Change Theme: • Issue Definition • PRINCE2® Approach to Change • PRINCE2® Change Documentation • Issue Register • Change Control Approach • Change Budget • Issue and Change Control Procedure • Issue Report • Exception Report Module 14: Controlling a Stage (CS): • Activity Breakdown • Authorise a Work Package • Work Package • Review Work Package Status • Receive Completed Work Packages • Review the Management Stage Status • Report Highlights • Highlight Report • Capture and Assess Issues and Risks • Escalate Issues and Risks • Take Corrective Action • Tailoring CS Module 15: Managing Product Delivery (MP): • Accept a Work Package • Execute a Work Package • Checkpoint Report • Deliver a Work Package • Tailoring MP Module 16: Managing a Stage Boundary (SB): • Plan the Next Management Stage • What is in a Plan? • Update the Project Plan • Update the Business Case • Report the Management Stage End • End-Stage Report • Produce an Exception Plan • Tailoring SB Module 17: Closing a Project (CP): • Prepare Planned Closure • Hand Over Products • Evaluate the Project • End Project Report • Recommend Project Closure • Tailoring CP Module 18: Considerations for Organisational Adoption: • Creating a PRINCE2® Based Project Management Method • Creating Tailoring Rules and Guidelines • Rating the Complexity of Projects • Embedding PRINCE2® • Tailoring • What Should Be Tailored? • Tailoring Constraints and Influences • Creating an Organisation’s Method DURATION 6 days WHATS INCLUDED Course Material Case Study Experienced Lecturer Refreshments Certificate

Our training programme will provide those involved at any stage of the process for procuring goods and/or services within their organisations with the knowledge and skillset to identify and mitigate the threat posed by the breadth and multi-layered complexity of procurement fraud, corruption and associated financial crime and money laundering.

The Quintessential Customer Experience (QCx) Forum is a ‘peer advisory’ community of communications and Cx professionals whose primary objectives are: To help members keep abreast of the latest CX developments To share best practice across different industry sectors. To provide individual support, advice and guidance for members Membership includes quarterly meetings, team coaching, 1:1 mentoring and online resource. Benefits The QCx Forum benefits both the CX professional and the organisations they work for. Employer Benefits include: Benchmarking performance against organisations in different sectors Keeping up to date with latest trends Maintaining competitive advantage through exceptional customer experience. Individual Member Benefits include: Inspiration for new ideas and approaches Guidance and advice to implement new strategies Support and reassurance from peers What’s included: The current membership package* includes: Forum Meetings Quarterly ‘Mastermind Group’ gatherings in person at a London venue. Each meeting features a specialist speaker providing insights about new trends and best practice. Team Coaching Attendees have the opportunity to share and solve key CX-related challenges they face.  1:1 Mentoring Support Members have access expert mentors to develop new strategies, gain valuable new knowledge and enhance their professional growth. Online Resource Members have access to a dedicated portal providing access to useful templates, tools and articles. * The first annual conference is planned for 2024 Membership Fees and options Three options are available: Essentials - quarterly Forum meetings, team coaching and online resources. £1,400.00 (ex VAT) pa Standard annual membership - includes quarterly forum meetings, team coaching, 4 x 1:1 mentoring sessions and online resource.  £3,600.00 (ex VAT) per annum Platinum membership - over and above the standard membership, includes an intensive quarterly programme of bi-weekly coaching sessions  £4,700.00 (ex VAT) per annum Credentials The Chair of the QCx Forum is Quentin Crowe MA, FCIM. His CX consultancy journey began in 2001 working with clients in the fitness and education sectors. Using an adaptation of the SERVQUAL methodology, he and his team have worked with clients in the charity, quality assurance, construction and cutout sectors (including ISG). Quentin also mentors entrepreneurs, senior marketers and corporate executives. He also chairs a number of ‘mastermind’ groups.  Brands represented include Shell, Asahi, Reuters and St James’s Place Welsh Management.

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