Project Management Office The goal of this course is to equip the participant with the necessary knowledge and skills to establish, improve, and support a project management office (PMO) that is the catalyst for portfolio and delivery management excellence. This course addresses the complexities of both understanding and choosing the correct PMO framework from among several alternatives. Additionally, the typical PMO supporting elements: domains of work, maturity level, and performance metrics, are elaborated. These elements position a PMO to realize and sustain the business value anticipated by the organization. What You Will Learn At the end of this program, you will be able to: Define a PMO and articulate on its benefits to an organization Explain how a PMO facilitates organizational success Differentiate among the varied PMO frameworks Apply to a PMO framework, domains of work, metrics, and organizational maturity Describe the competency frameworks for management functions within a PMO Plan for and implement a PMO to ensure it is of business value Foundation Concepts Definitions and concepts PMO frameworks PMO domains PMO benefits PMO Frameworks Organizational unit PMO Project-specific PMO Project support or services PMO Center of excellence Enterprise PMO PMO Domains I Strategic planning Standards, methodologies, and processes Governance and performance management Organizational change management PMO Domains II Portfolio management Project and program delivery management Administrative support, knowledge, and talent management PMO Metrics and Maturity PMO metrics PMO maturity PMO maturity assessments PMO Implementation Originating and initiating a PMO Developing a PMO implementation plan Implementing a PMO
Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 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 17 Points Development Level Develop
Who is this course for? The Architecture and Interior Design course is ideal for individuals aiming to master both interior design and architecture. Guided by certified tutors from Autodesk and Adobe, students will gain comprehensive skills in these fields. Click here for more info: Website Duration: 40 hours.1-on-1 Training. In-Person or Live online. When can I book: 9 am - 7 pm (Choose your preferred day and time once a week). Flexible timing with advance booking Course Features: Compatibility: Our training courses are compatible with both Mac and Windows operating systems, ensuring accessibility for all users. Price Assurance: We guarantee the best value for your investment, ensuring competitive pricing for high-quality training. Personalized Training: Benefit from one-on-one training sessions tailored to your specific needs and skill level, ensuring a personalized learning experience. Flexible Scheduling: Enjoy the flexibility to choose your preferred training time and day. Sessions are available seven days a week, from Monday to Sunday, between 9 am and 8 pm, accommodating your busy schedule. Lifetime Support: Receive lifetime email and phone support, ensuring that you have access to assistance even after completing the course. Technical Assistance: Get help with configuring your computer for software installation, ensuring a smooth learning experience without technical hurdles. Referral Discounts: Earn special discounts when you refer a friend to our courses, making learning a rewarding experience for you and your network. Group Training Savings: Avail significant savings on group training courses, encouraging collaborative learning and making education more accessible for groups. When can you schedule this Training Course? Personalized training experience with our flexible 1-on-1 sessions. Design your own timetable by pre-booking a convenient hour of your choice, available from Monday to Saturday between 9 a.m. and 7 p.m. Alternatively, you can call 02077202581 to book over the phone. How long is the training? The course spans 40 hours, which you can divide over as many days as needed to fit your ideal schedule. What's the teaching method? Our sessions are 1-on-1, offered either in-person face to face or live online. You'll receive personalized attention, tailored content, a flexible learning pace, and individual support. Live online 1-on-1 sessions over Zoom are also an option. What will you learn? In this comprehensive training program, you'll gain proficiency in a thoughtfully curated selection of software tools. Option A: AutoCAD (13 hours) SketchUp (10 hours) Vray (6 hours) Photoshop (6 hours) InDesign (5 hours) Additionally, you'll receive free online portfolio design assistance, career growth guidance, and mock interviews to enhance your job market readiness. Option B: AutoCAD (10 hours) 3ds Max (17 hours) Vray (4 hours) Photoshop (5 hours) InDesign (4 hours) Certified trainers in AutoCAD, 3ds Max, SketchUp, and Adobe software will conduct this training program. It caters to beginners, intermediate, and advanced learners, focusing on core skills for creating 2D drawings, plans, sections, elevations, construction details, and 3D visualizations. Our experienced instructors will guide you through essential commands and methodologies for producing precise 2D and 3D drawings. We have developed these CAD courses, utilizing the expertise of our professionals to provide the most efficient and effective instruction. Upon completion, participants will: Master Software Tools: Excel in AutoCAD, SketchUp, Vray, Photoshop, and InDesign for digital design. Advanced Design Skills: Create intricate 2D/3D designs, plans, and visualizations. Project Management: Manage layouts, plotting, and projects efficiently. Realistic Rendering: Produce lifelike visualizations using Vray. Creative Composition: Understand design principles for impactful creations. Portfolio Development: Create a professional online portfolio. Career Readiness: Prepare for job interviews and enhance resumes. Potential Jobs: Architect Interior/Exterior Designer CAD Technician Visualization Specialist Design Consultant Project Manager These skills open doors to varied roles in architecture and design, ensuring career growth and job readiness. Course Features: Compatibility: Our training courses are compatible with both Mac and Windows operating systems, ensuring accessibility for all users. Price Assurance: We guarantee the best value for your investment, ensuring competitive pricing for high-quality training. Personalized Training: Benefit from one-on-one training sessions tailored to your specific needs and skill level, ensuring a personalized learning experience. Flexible Scheduling: Enjoy the flexibility to choose your preferred training time and day. Sessions are available seven days a week, from Monday to Sunday, between 9 am and 8 pm, accommodating your busy schedule. Lifetime Support: Receive lifetime email and phone support, ensuring that you have access to assistance even after completing the course. Technical Assistance: Get help with configuring your computer for software installation, ensuring a smooth learning experience without technical hurdles. Referral Discounts: Earn special discounts when you refer a friend to our courses, making learning a rewarding experience for you and your network. Group Training Savings: Avail significant savings on group training courses, encouraging collaborative learning and making education more accessible for groups. When can you schedule this Training Course? Personalized training experience with our flexible 1-on-1 sessions. Design your own timetable by pre-booking a convenient hour of your choice, available from Monday to Saturday between 9 a.m. and 7 p.m. Alternatively, you can call 02077202581 to book over the phone. How long is the training? The course spans 40 hours, which you can divide over as many days as needed to fit your ideal schedule. What's the teaching method? Our sessions are 1-on-1, offered either in-person face to face or live online. You'll receive personalized attention, tailored content, a flexible learning pace, and individual support. Live online 1-on-1 sessions over Zoom are also an option. What will you learn? In this comprehensive training program, you'll gain proficiency in a thoughtfully curated selection of software tools. Option A: AutoCAD (13 hours) SketchUp (10 hours) Vray (6 hours) Photoshop (6 hours) InDesign (5 hours) Additionally, you'll receive free online portfolio design assistance, career growth guidance, and mock interviews to enhance your job market readiness. Option B: AutoCAD (10 hours) 3ds Max (17 hours) Vray (4 hours) Photoshop (5 hours) InDesign (4 hours) Certified trainers in AutoCAD, 3ds Max, SketchUp, and Adobe software will conduct this training program. It caters to beginners, intermediate, and advanced learners, focusing on core skills for creating 2D drawings, plans, sections, elevations, construction details, and 3D visualizations. Our experienced instructors will guide you through essential commands and methodologies for producing precise 2D and 3D drawings. We have developed these CAD courses, utilizing the expertise of our professionals to provide the most efficient and effective instruction.
For those seeking perfection in polishing techniques. The UKDA Advanced Machine Polishing (professional) Course is a day for those who would like to develop their technique further on all machine styles to produce the high-end, high-efficiency finish that is the marque of the most accomplished detailers. Taking cues from any existing experience, we will push the boundaries of your polishing abilities over the edge, running rotary DA and forced drives to their limit to give to the skills to drive up your efficiency and perfect paint like never before. The UKDA Advanced Machine Polishing (professional) Course is a 2 day for those who would like to develop their technique further on all machine styles to produce the high-end, high-efficiency finish that is the marque of the most accomplished detailers. Far from there being a consistent method - there are a number of subtle variations you can make to what would be termed a 'standard' technique which will speed up your process, enhance further your gloss extracting capabilities and make the right choice in machine based on paint types, conditions and ancillary equipment. On this day we will run through variables in speed and pad choices, show the differences ambient temperature and rebound can make to a job, explain the different approaches based on clear coat solids, look at how far you can push a painted surface, and much much more. The course is run over two full days (9.30 am - 4.30 pm) and picks up where both our introduction course and the Flexxpert Seminar leave off, so is also the perfect follow-up to those who have attended either course, in addition to those who want to learn all about machine polishing in every style. Alternatively, if you are machine polishing in your day-to-day work outside of detailing and feel you have scope to improve, or you keep coming up against small issues, this is the course for you. Not sure if it suits you? Why not call or message one of our team, and we'll be happy to discuss which course is right for you. Course Length 2 Days (0930-1600) Group Size One-to-One, Up to 2 people Location UK Detailing Academy, 2 Purlieus Barn, Ewen, Cirencester, GL7 6BY Experience / Qualification Competent with preparation and decontamination procedures Refreshments or Lunch Lunch NOT included, Refreshments included
Who is this course for? This course is ideal for individuals interested in learning landscape architecture, emphasizing the planning, design, and management of various outdoor spaces, such as private gardens, public parks, and commercial landscapes. Click here for more info: Website 1-on-1 training, Monday to Saturday, 9 a.m. to 7 p.m., or call to book. Tailor your 40-hour course Option A: AutoCAD, Sketchup, Vray, and Photoshop. Option B: Rhino, Sketchup, Vray, and Photoshop. Both covering specializes in Planting Plans and Maps. Course Outline - Option A: AutoCAD, Sketchup, Vray, Photoshop (Total: 40 hours) AutoCAD (10 hours): Module 1: Introduction to AutoCAD (2 hours) - Overview of AutoCAD interface and tools - Creating, opening, and saving drawings - Basic drawing and editing commands Module 2: Drawing and Editing (3 hours) - Working with lines, circles, and arcs - Utilizing polylines and polygons - Modifying objects: Move, Copy, Rotate, and Scale Module 3: Precision Drawing (3 hours) - Using coordinate systems for precision - Dimensioning and text incorporation - Hatching and gradients for added detail Module 4: Advanced Tools (2 hours) - Leveraging blocks and attributes - Managing layers and object properties - Creating layouts and preparing for plotting Sketchup (16 hours): (Specializing in Planting Plans, Vegetation Plans, and Maps) Module 1: Introduction to Sketchup (2 hours) - Navigating the Sketchup interface - Grasping basic 2D and 3D modeling concepts - Creating and manipulating objects Module 2: Advanced Modeling (6 hours) - Model intricate garden elements with curves and surfaces - Expertly edit and transform geometry - Specialized focus on Planting Plans, Vegetation Plans, and Maps Module 3: Visualization with Vray (4 hours) - Understanding the Vray rendering engine - Applying materials and textures for realism - Setting up lighting and cameras for realistic rendering Module 4: Image Enhancement with Photoshop (10 hours): - Introduction to Photoshop for design purposes - Editing and enhancing Sketchup and Vray outputs - Creating visually striking presentations Additional Resources: Access free online portfolio design assistance, career growth guidance, and mock interviews to ensure your readiness for the competitive job market. Course Outline - Option B: AutoCAD, Rhino, Vray, Photoshop (Total: 40 hours) AutoCAD (12 hours): Module 1: Introduction to AutoCAD (2 hours) - Overview of AutoCAD interface and tools - Creating, opening, and saving drawings - Basic drawing and editing commands Module 2: Drawing and Editing (3 hours) - Working with lines, circles, and arcs - Utilizing polylines and polygons - Modifying objects: Move, Copy, Rotate, and Scale Module 3: Precision Drawing (3 hours) - Using coordinate systems for precision - Dimensioning and text incorporation - Hatching and gradients for added detail Module 4: Advanced Tools (4 hours) - Leveraging blocks and attributes - Managing layers and object properties - Creating layouts and preparing for plotting Rhino (14 hours): Module 1: Introduction to Rhino (2 hours) - Navigating the Rhino interface - Grasping basic 2D and 3D modeling concepts - Creating and manipulating objects Module 2: Advanced Modeling (6 hours) - Model intricate garden structures with curves and surfaces - Proficiently edit and transform geometry - Build complex 3D structures Module 3: Visualization with Vray (6 hours) - Setting up lights and cameras for garden renders - Exploring rendering settings and options - Post-production and compositing techniques Image Enhancement with Photoshop (8 hours): - Introduction to Photoshop for design purposes - Editing and enhancing Rhino and Vray outputs - Creating visually striking presentations Both Option A and Option B provide comprehensive training in essential design software, with the choice between specialization in Sketchup (Option A) or a broader skill set with Rhino (Option B). Additionally, both options offer access to valuable resources for career preparation. When Can I Book this Training Course? Personalized 1-on-1 training sessions available, allowing for a tailored learning experience. Pre-book your preferred time slot from Monday to Saturday between 9 a.m. and 7 p.m. Alternatively, call 02077202581 to book over the phone. Training Duration 40-hour training program, with the flexibility to split hours based on your ideal learning schedule. Training Method Choose between in-person Face to Face or Live Online 1-on-1 training. Expect personalized attention, flexible learning pace, and individualized support throughout your training. Live Online sessions available over Zoom for added convenience. Enroll in our 1-on-1 Course Today! Comprehensive Training Program Overview Option A: AutoCAD (10 hours) Sketchup (16 hours) (Specializing in Planting Plans, Vegetation Plans, and Maps) Vray (4 hours) Photoshop (10 hours) Option B: AutoCAD (12 hours) Rhino (14 hours) Vray (6 hours) Photoshop (8 hours) Benefits of Option A: Diverse Skillset: Gain expertise in AutoCAD, Sketchup, Vray, and Photoshop for various design fields. Specialization: Focus on Planting Plans, Vegetation Plans, and Maps within Sketchup. Realistic Renderings: Learn Vray for compelling 3D renderings. Image Editing: Enhance images effectively with Photoshop. Career Readiness: Access resources like portfolio design assistance and mock interviews for job market readiness. Benefits of Option B: Versatile Expertise: Master AutoCAD, Rhino, Vray, and Photoshop for various design disciplines. Advanced 3D Modeling: Excel in complex designs with Rhino and 3ds Max. Quality Renderings: Create impressive 3D renderings with Vray. Image Editing Mastery: Perfect design concepts with Photoshop. Additional Training Course Benefits: Compatible with both Mac and Windows operating systems. Price Assurance for exceptional value. Flexible scheduling from Monday to Sunday, 9 am to 8 pm. Lifetime Email and Phone Support. Assistance in configuring your computer for seamless software installation. Referral Benefits, including special discounts for friend referrals and savings on group training courses.
Who is this course for? The Garden Design Training Courses are suitable for individuals interested in learning how to plan, design, and manage outdoor spaces, including public parks, gardens, parks, and commercial landscapes. Jobs: Landscape Designer, Consultant, Garden Planner, Green Space Developer, Urban Garden Designer. Click here for more info: Website Personalized 1-on-1 sessions. Book between 9 a.m. and 7 p.m., Mon to Sat. (Book anytime and day). The 40-hour program includes AutoCAD, Sketchup, Vray, IndDesign and Photoshop. Garden Design Software Training Course Options Option A: AutoCAD, Sketchup Pro, Vray, Photoshop (Total: 40 hours) AutoCAD (10 hours): Module 1: AutoCAD Fundamentals (2 hours) - Explore the AutoCAD interface and its toolset - Master drawing creation, management, and storage - Utilize essential drawing and editing commands Module 2: Drawing and Editing Mastery (3 hours) - Achieve precision drawing with lines, circles, and arcs - Create complex shapes with polylines and polygons - Proficiently use object modification tools: Move, Copy, Rotate, and Scale Module 3: Precision and Detail (3 hours) - Implement coordinate systems for accuracy - Learn dimensioning techniques and text incorporation - Elevate designs with hatching and gradients Module 4: Advanced Design Tools (2 hours) - Harness the power of blocks and attributes - Manage layers and object properties efficiently - Craft layouts and prepare for plotting Sketchup Pro (16 hours): Specializing in Garden Planning (Planting Plans, Vegetation Layouts, and Maps) Module 1: Introduction to Sketchup Pro (2 hours) - Navigate the Sketchup Pro interface - Understand essential 2D and 3D modeling concepts - Create and manipulate garden design objects Module 2: Advanced Garden Modeling (6 hours) - Sculpt intricate garden elements with curves and surfaces - Expertly edit and transform garden geometry - Focus on Planting Plans, Vegetation Layouts, and Maps Module 3: Visualization Excellence with Vray (4 hours) - Master the Vray rendering engine for lifelike garden visuals - Apply materials and textures for realism - Set up optimal lighting and camera angles for compelling garden renders Module 4: Image Enhancement through Photoshop (10 hours) - Use Photoshop for garden design refinement - Elevate garden images from Sketchup and Vray outputs - Create visually stunning presentations for garden projects Additional Resources: Gain access to invaluable resources, including free online portfolio design assistance, career growth guidance, and mock interviews, ensuring your readiness for the competitive garden design job market. Option B: AutoCAD, Rhino, Vray, Photoshop (Total: 40 hours) AutoCAD (12 hours): Module 1: AutoCAD Introduction (2 hours) - Unveil the AutoCAD interface and its feature set - Master drawing creation, management, and storage - Proficiency in fundamental drawing and editing commands Module 2: Drawing and Editing Proficiency (3 hours) - Apply precision drawing techniques, including lines, circles, and arcs - Construct complex shapes with polylines and polygons - Skillfully use object modification commands: Move, Copy, Rotate, and Scale Module 3: Precision and Detail Mastery (3 hours) - Implement coordinate systems for precision - Explore comprehensive dimensioning methods and text integration - Enhance designs with hatching and gradients Module 4: Advanced Design Tools (4 hours) - Gain expertise in blocks and attributes for efficient design - Efficiently manage layers and object properties - Craft layouts and prepare for plotting Rhino (14 hours): Module 1: Rhino Introduction (2 hours) - Navigate within the Rhino interface - Understand essential 2D and 3D modeling concepts for garden design - Create and manipulate garden design objects Module 2: Advanced Garden Modeling (6 hours) - Craft intricate garden structures using curves and surfaces - Proficiently edit and transform garden geometry - Build complex 3D garden structures Module 3: Visualization Mastery with Vray (6 hours) - Set up optimal lighting and camera angles for garden renders - Explore rendering settings and options for high-quality outputs - Learn post-production techniques and compositing for exceptional garden visuals Module 4: Image Enhancement with Photoshop (8 hours) - Utilize Photoshop for refining garden design concepts - Enhance garden images from Rhino and Vray outputs - Create visually striking garden presentations for projects Garden Design Training Course Information When Can I Book This Training Course? - Immerse yourself in a personalized training experience with our flexible 1-on-1 training sessions. - Tailor your schedule by pre-booking a convenient hour of your choice. - Available for booking from Monday to Saturday between 9 a.m. and 7 p.m. - Alternatively, you can call 02077202581 to book over the phone. Training Duration - This comprehensive course spans 40 hours, which you can split over as many days as needed to create your ideal learning schedule. Training Method - We offer 1-on-1 training, which can be conducted either in-person Face to Face or Live Online. - Expect personalized attention, customized content, a flexible learning pace, and individualized support throughout your training. - We also provide the option of Live Online 1-on-1 sessions over Zoom for added convenience. Enroll Today - If you're ready to embark on this enriching journey, click the link below to enroll in our 1-on-1 Course. Garden Design Software Training Overview In our comprehensive garden design training program, you'll cultivate your expertise using a thoughtfully selected array of industry-leading software tools, ensuring you're well-prepared to bring your garden designs to vibrant life. Option A: - AutoCAD (10 hours): Craft precise garden layouts and plans. - SketchUp (16 hours): Specialize in garden planting plans, vegetation layouts, and maps. - Vray (4 hours): Create lifelike 3D renderings of your garden designs. - Photoshop (10 hours): Enhance garden images effectively. Option B: - AutoCAD (12 hours): Develop garden blueprints with precision. - Rhino (14 hours): Master 3D modeling for intricate garden designs. - Vray (6 hours): Craft stunning 3D visualizations of your gardens. - Photoshop (8 hours): Perfect your garden design concepts. Both options accommodate Mac and Windows operating systems, ensuring accessibility for all learners. Key Benefits Price Assurance: We are committed to delivering exceptional value for your investment in a flourishing garden design career. One-on-One Training Sessions: Tailored learning experiences designed to adapt to your unique learning style. Flexible Scheduling: Choose your preferred training time and day, with availability from Monday to Sunday, spanning from 9 am to 8 pm. Lifetime Email and Phone Support: Ongoing support continues beyond your training period, facilitating your career growth. Computer Configuration Assistance: We provide guidance to ensure a seamless software installation on your computer. Referral Benefits: Enjoy special discounts when referring a friend and substantial savings on group training courses.
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 Our extensively proven course delves into the essential stages of process and system auditing. Gain invaluable insights and direction in auditing systems and processes, spanning across global and local organisational levels. This course will assist delegates with: A practical approach for the development and conduct of process and system audits An enhanced understanding of key system audit principles, preparation, design and conduct Increased expertise, efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Share knowledge and experiences. By the end of the course delegates will be better able to: Design and plan more effectively to achieve their process and systems audit objectives and add value to their organisation Improve the effectiveness, focus and credibility of the audit programme Understand the key system audit principles, preparation, design and conduct Develop system audit tools to ensure more effective audit conduct and outcome Create audit strategies utilising risk management principles Prepare for inspections. Tutors Tutors will be comprised of (click the photos for biographies): Allison Jack Executive Director, Bristol Myers Squibb Rocio Castellanos Director, Pfizer Ltd Guy Houben G(C)LP Auditor, Janssen Pharmaceutical Companies of Johnson & Johnson Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introductions, Expectations/Challenges/Experiences A discussion to explore the range of approaches to the conduct of systems audit. 09:30 Introducing Systems Audit What is a system? Why conduct system audits? Advantages, disadvantages and challenges. 10:20 Break 10:35 Systems Audit Design and Planning Identifying the customer, setting objectives, development of the audit plan and audit tools, plans for the audit report. 12:00 Designing System Audit Tools 12:45 Lunch 13:30 System Audit Plan - Exercise 14:00 Introduction to Case Studies The objectives of the case studies are defined and process and outputs described. 14:15 Case Studies - Session 1 A first opportunity for work on case studies. Defining objectives and scope and understanding the requirements of the audit client. 15:00 Break 15:20 Case Studies - Session 1 continued 16:30 Case Studies - Feedback 17:00 Close of Day 1 Day 2 09:00 Simple System Audit Example - Introduction The objectives of the case studies are defined and process and outputs described. 09:10 Case Studies - Session 2 - A Simple System Audit Example An example of system audit applied to a simple system. 10:30 Break 10:45 A Simple System Audit Example - Case Study Feedback 11:30 Strategy Audit programme planning. 12:15 Lunch 13:00 Case Studies - Session 3 Work on delegate's case studies. 14:30 Break 14:45 Case Studies - Session 3 - Feedback 15:15 Closing remarks 15:30 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 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