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1579 Courses

Process Mapping and Standard Operating Procedure (SOP) Writing

By Research Quality Association

Course Information This course aims to empower you with the expertise to proficiently navigate process mapping and master the art of crafting Standard Operating Procedures (SOPs) within regulated environments. Whether you're engaged in activities that demand process improvement, continual enhancement, or SOP creation, this course offers invaluable insights tailored to your needs. It caters to individuals tasked with managing, documenting, and implementing processes and SOPs, irrespective of prior experience or skills. Our curriculum does not focus on specific software or approaches, focusing instead on fundamental principles and adaptable concepts applicable across diverse organisational landscapes. Benefits include: Hands-on experience in mapping processes An understanding of how process maps can be used to define, communicate and continually improve complex processes An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text An insight into the preparation of concise and user friendly SOPs. This course is structured to encourage delegates to:  Discuss and develop ideas Develop a practical approach for creating process maps and writing SOPs Understand how to use process maps in SOPs effectively Discuss how process mapping for preparing SOPs can be applied to process improvement for SOPs. Is this course for you? The course is designed for all those with responsibility for managing, documenting and implementing processes and SOPs. It assumes no prior experience or skills. The course does not recommend any specific software or approach, but explores the principles and ideas that can be applied in any organisation. What will you learn? Hands-on experience in mapping processes An understanding of how process maps can be used to define, communicate and continually improve complex processes An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text An insight into the preparation of concise and user friendly SOPs. By the end of the course you will be able to: Create process maps and write clearer more concise SOPs Understand how to use process maps in SOPs effectively Understand how process mapping can be applied to process improvement and better SOPs. Tutors Tutors will be comprised of (click the photos for biographies): Laura Brown Director, Laura Brown Training and Development David Butler VP of Quality, Resolian Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome, Introductions and Course Objectives Why Companies manage by process. 10:00 Exercise 1 - First Steps Mechanisms for process mapping, levels at which it can be applied, and the roles and responsibilities of process owners. 10:30 Exercise 1 - Feedback 10:45 Break 11:00 Mapping Processes The stages involved in mapping processes including how to construct a SIPOC chart. 11:45 Exercise 2 - Mapping A Process A first opportunity to practice your new process mapping skills. 12:30 Exercise 2 - Feedback 13:00 Lunch 14:00 Exercise 3 - Discussion of Options for Format, Structure and Layout What Makes A Good SOP? Discussion of options for format, structure, level of detail of SOPs and the use of process maps for SOP writing. A case study example of a good SOP which uses a flow chart/process map. 14:45 Exercise 3 - Feedback 15:00 Break 15:15 A Case Study example of a good SOP that uses a flow chart / process map 15:30 Exercise 4 Discussion of the content of an SOP using a Process Map 15:35 Exercise 4 - Feedback 15:45 Key Writing Considerations 16:15 Exercise 5 16:45 Exercise 5 - Feedback 17:00 Close of Day Day 2 09:00 Review of Day 1 09:15 Using Metrics Selecting and using metrics to monitor and improve processes. 10:00 Exercise 6 - Practice in Process Mapping Creating Process Maps from multi-source information. 11:00 Break 11:15 Exercise 6 - Feedback 11:45 Common Pitfalls Common problems and tips for good Process Mapping. 12:15 Demonstration of Process Mapping on a PC 12:45 Lunch 13:30 Exercise 7 - Mind Mapping 14:30 Exercise 7 - Feedback 15:00 Break 15:15 Exercise 8 - Using Process Maps to Write an SOP Applying your process mapping skills as part of writing an SOP 15:30 Exercise 8 - Feedback 15:45 Course Review and Follow-up 16:00 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. Development Level Learn

Process Mapping and Standard Operating Procedure (SOP) Writing
Delivered in person or OnlineFlexible Dates
£858 to £1,112

RYA Intermediate Powerboat

4.9(31)

By Torbay Sea School

This 2 day course builds upon the basic knowledge and skills covered in the Level 2 course and is aimed at those who want to drive larger and more powerful powerboats and is a good step to progressing onto the Advanced course. This course covers the practical use of pilotage and passage planning by day on coastal waters using both traditional and electronic navigational techniques, boat preperation, cruising at planing speed, advanced boat handlingand man overboard drills. By the end of the course you will be able to plan and execute short coastal passages by day. It is strongly recommended that candidates hold a first aid certificate and a VHF/SRC operator's certificate. Power Courses Our powerboat training is currently delivered on an MCA coded 7.8m Ribcraft with a 200hp Suzuki four stroke outboard engine and an E-series Raymarine chart plotter. We maintain a 3:1 student to instructor ratio which allows our experienced RYA instructors to tailor courses to the various levels and needs on board and deliver at a manageable pace. All course costs include tea and coffee, waterproofs are available on request.

RYA Intermediate Powerboat
Delivered In-PersonFlexible Dates
£370

The customer journey is changing faster than ever before. Can you keep up? Our brand-new Search Marketing course is here to get you ready – with the chance to learn directly from top SEO expert Neil Patel and his team. Course Overview The customer journey is changing faster than ever before. Can you keep up? Our brand-new Search Marketing course is here to get you ready – with the chance to learn directly from top SEO expert Neil Patel and his team. Did you know that search marketing is currently one of the most in-demand roles? And that growth isn’t going to stop anytime soon. Develop true Search Marketing expertise for where search is now and where it’s going Program learning outcomes and content: What Will I Learn? Develop the skills to work in search right now. Learn about search engine optimization, paid search, and digital display advertising, along with the latest platforms including Google Ads, Microsoft Ads (Bing Ads), and Google Analytics 4. Study using a dynamic mix of interactive lessons, videos, and downloadable tools, along with live sessions on the latest trends and channels. You’ll be awarded with a DMI search marketing certification that’s recognized globally, along with a completion badge from Neil Patel. Course Content: Introduction to Search Marketing: Being found in the right place at the right time may look effortless but it’s an art. You’re going to need lots of key concepts, tools and tricks. Explore how the core search elements work together to drive targeted traffic that converts into sales. • Search Marketing • SEO & Paid Search principles • Demand generation • Analytics & reporting • Data visualization SEO Setup & Content: The search engine can feel all seeing, all knowing but it can be won over. SEO is the way to come out on top. Understanding the algorithms and ranking factors puts you in the driver’s seat. But that’s not all. What does it take to really engage people? Content that speaks to them. Find out what your audiences are looking for, create the content they care about, and then serve it to them where they are. The key to a big, visionary content strategy that works. • Setting SEO objectives • Keyword research • Creating content • On-page optimization • Content scheduling Optimizing SEO: Everyone wants to get their website in front of more people. The right people. That’s where search engine optimization comes in. There’s a lot to get a handle on with SEO, all working together to make your content more visible. Pick the quick wins, gather momentum, or optimize for a better return-on-investment. • SEO for eCommerce • Backlinking for authority • Local & international optimization • Off-page optimization Paid Search Fundamentals: So you know how to grow those organic searches and it’s going well. But you want to succeed faster. Cut right to the chase with paid search. Learn the fundamentals of PPC advertising and how it can work to promote your business. • Paid search concepts • Ads & landing pages • Keywords • Creating a paid search campaign Paid Search Campaigns: Now that you know the basics, it’s time to start running your campaigns. Use PPC advertising to boost your visibility. Discover how to measure and optimize your campaigns to get the best out of every single click. • Managing the campaign budget • Optimizing campaigns • Reporting on paid search Demand Generation: Capture interest wherever people are in their journey. Whether they’re a first time visitor, just getting to know you or coming back again and again. Demand generation gives you the tactics to drive awareness and long-term engagement. Sure, it takes time but it’s worth the payoff. • Demand generation campaigns • Outbound channels & ad formats • Campaign targeting & bidding • Optimizing your campaign • Involving display & video advertising Search Analytics: Search analytics can feel a bit like having a superpower. There’s so much you can know about what your target market is doing, what they want, how they speak. All of this data is at your fingertips, you just need to know how to use it. So let’s dive in. Plus with the shift to Google Analytics 4 daunting many businesses, we’ll get you set for success on the new interface. • Analytics fundamentals • Monitoring campaigns • Introduction to GA4 • Configuring Google Analytics • Conversion rate optimization Data& Data Visualization: Data gives us so many new insights and opportunities to work with. But we’re always looking for ways to make data more engaging, especially in a digital world where we have so much of it. Tell the story of what you’ve discovered with data visualization. It helps to communicate more effectively and bring everyone along for the journey. • Turning data into actions • Ways of visualizing data • Forecasting search performance Search Strategy - Research & Planning: So you have tools, techniques, and practiced skills. You’ve learned all of the stepping stones behind making search work hard. Now is your chance to get an action plan together. A strategic, focused plan that really delivers. One backed up by research and structured by set objectives. • Planning a search strategy • Research for search campaigns • Setting objectives for search Search Strategy 2 - Execution & Optimization It’s time to put everything you’ve learned into practice with a high-performing search marketing strategy. You have the skills, you’ve done the research, your action plan is prepared. Let’s execute the strategy and make it a reality. Exciting, isn’t it? • Omnichannel search approach • Adapting to change • Evaluating search strategies • Long term performance DURATION 8-10 Weeks WHATS INCLUDED Course Material Case Study Experienced Lecturer Refreshments Certificate

DMI Specialist Search
Delivered In-PersonFlexible Dates
£1,500

Bespoke Management Training

By Dickson Training Ltd

One of our greatest strengths is our ability to tailor any of our open management courses to the needs and requirements of different businesses in different industries. We understand that whilst our open management training courses provide a wealth of knowledge in their particular area of focus, not all of it may be relevant for your business and the particular industry you operate in.Rather than making delegates sit through management training that is irrelevant to their job role, we offer bespoke management training where we tailor the course to cover the specific needs of your organisation, ultimately relieving the inevitable boredom and "switching off" that would come with having to sit through training that a person knew they would not need. Why choose us for your bespoke management training needs? We have provided tailored, bespoke management training courses to some of the largest organisations in the UK. Using our acquired experience and knowledge of running these courses, we will be able to work with you to create a bepoke management training programme that delivers a significant return on investment, both in terms of tangible and intangible results. ILM accredited management training courses Because we charge a daily training rate rather than a per delegate fee, if you have a number of delegates requiring management training, a bespoke management training course can often be less expensive than putting them all on an open course. A number of courses have been accredited by the ILM, which means you can be assured as to the standard of the course content and delivery. For more information on these, please see our page on ILM Management Training. All of our ILM Programmes are provided in partnership with BCF Group Limited, which is the ILM Approved Centre we deliver under. Interested in finding out more about bespoke management training? Between us, we can come up with a training plan which will provide relevant, bespoke management training for your delegates which will maximise the return on both your time and cost. We are happy to come to your premises or arrange training facilities nearer to your location if this would be more convenient. Feedback Below is a small selection of past feedback for our management training and development courses and programmes: "Excellent instructor. I looked forward to our monthly lectures knowing that I would have a good laugh but also that I would learn more about the subject and myself. He has been very helpful to me and the rest of the students, not just during the lectures but often in his own time. His enthusiasm for all of the subjects covered during the course was evident throughout, which again helped me to enjoy and understand the subjects and lectures.  If I get the chance in future to attend a further course with you, I would jump at the chance."Senior Acquisitions SurveyorGalliford Try "A very accomplished trainer and someone who I would very much like to be involved in our business training going forward. The feedback I have had from all levels of our team structure is excellent."Group HR OperationsEADS Personnel Services UK "Phil has a lot of energy which he throws into the course. This visably broke down resistance and attendees entered into the exercises wholeheartedly."Senior QSBullock Construction Scheduled Courses Unfortunately this course is not one that is currently scheduled as an open course, and is only available on an in-house basis. Please contact us for more information.

Bespoke Management Training
Delivered In-Person in Bardsey + 3 more or UK WideFlexible Dates
Price on Enquiry

PRINCE2 is a process-based project management methodology that offers a flexible and scalable solution to handle all kinds of projects. This is why many organisations favour it since it fosters better collaboration between team members and external stakeholders. Course Overview PRINCE2 is a process-based project management methodology that offers a flexible and scalable solution to handle all kinds of projects. This is why many organisations favour it since it fosters better collaboration between team members and external stakeholders. The PRINCE2 certification will surely help learners advance in terms of worth and employment opportunities if they list it as a skill in their resumes. This 3-day introductory PRINCE2® Foundation course is designed to give candidates a comprehensive overview of the PRINCE2® methodology. They will learn about various essential topics such as integrated elements, applying PRINCE2®, delivery approaches, processes, principles, tailoring, etc. The PRINCE 2 foundation course will introduce project management to students. This course will focus on different aspects of project management, providing the knowledge, tools and techniques used to understand each concept and methodology. At the end of this PRINCE2® Foundation course, delegates will be able to perform various project manager activities in an organisation effectively and efficiently. They will also be able to use various PRINCE2® methodologies properly. This training will also cover the following concepts: • Project management • Projects in context • Measuring success • Tailor to suit the project • Embedding PRINCE2® • Tailoring constraints and influences Who it’s for? Prerequisites: In this PRINCE2® Foundation course, there are no formal prerequisites. PRINCE2 Foundation can be studied on its own or as a prerequisite for the PRINCE2 Practitioner course This PRINCE2® Foundation course is designed for anyone who wants to gain in-depth knowledge about project management methodologies. What's Included in this PRINCE2 Foundation Training Course? The following is included in this PRINCE2® Foundation training course: • PRINCE2® Foundation Examination • Pre-course material • PDUs • Experienced PRINCE2® Instructor • Certificate • Refreshments PRINCE2® Foundation Exam: The PRINCE2® Foundation examination Focuses on knowledge of PRINCE2® as a methodology. • Type of Questions: Multiple choice. • Total Questions: 60. • Number of marks: 60 marks, each question is worth 1 mark. • Pass mark: 55%, or 33/60. • Duration: 60 Minutes. • Material allowed: No, this is a ‘closed book’ exam. This PRINCE2® foundation training course covers the following topics: Module 1: Introduction to Projects and the PRINCE2® Methodology: • PRINCE2® “Project” Definition • Project Characteristics • Project Management • What is PRINCE2®? • Four Integrated Elements • What Does PRINCE2® 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: 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 2-3 days WHATS INCLUDED Course Material Case Study Experienced Lecturer Refreshments Certificate

PRINCE2® Foundation
Delivered In-PersonFlexible Dates
£1,495

Age Diversity and Inclusivity: From Early Career and beyond, How do we best grow our talent?

By Biogen Booking System

Join us for a round table discussion with Ginger Gregory, CHRO. Age Diversity and Inclusivity: From Early Career and beyond, How do we best grow our talent? As part of the UKI Wellbeing day we’re inviting everyone to participate in one of a series of roundtable focus groups hosted by HR and Ginger Gregory, our CHRO. These sessions are current organisational challenges designed to foster open dialogue, enhance collaboration, and gather your valuable insights. This is an opportunity to connect, share experiences, and contribute meaningfully to our organisation.

Age Diversity and Inclusivity: From Early Career and beyond, How do we best grow our talent?
Delivered In-PersonJoin Waitlist
FREE

The Art of Delegation and High-Impact Feedback (In-Person)

By IIL Europe Ltd

The Art of Delegation and High-Impact Feedback (In-Person) Whether you are a project manager, an executive, or simply someone involved in leading or helping others, a critical part of your work must involve delegating and giving feedback. These two skills, however, are not as simple as they seem. How do you know what to delegate? What kinds of feedback should you give? Knowing this and practicing this are two different things. Ultimately, delegating and giving feedback are skills that must be done mindfully, strategically, and meaningfully. They must be done in ways that not only positively impact performance, but also inspire growth, engagement, and motivation. When done poorly, they can create significant problems. But when done well, they can generate value for everyone and benefit future endeavors. In this course, you will learn to think more deeply about the importance of delegating and discover how to give better feedback. You will have opportunities to apply best practices and methodologies that you can use in the real world, ultimately paying off for you and for others. What You Will Learn At the end of this program, you will be able to: Explain why common excuses for NOT delegating are short-sighted Identify what needs delegating by using a proven methodology Utilize best practices in real world scenarios, delegating in a way that benefits you and the individual to whom you delegate Summarize key lessons learned in brain science which enhance the feedback-giving process Recognize the critical connection between feedback and performance Apply a proven model to deliver feedback that inspires growth, engagement, and motivation Delegation What is delegation? What makes delegation hard? What do I delegate and why? How to delegate effectively

The Art of Delegation and High-Impact Feedback (In-Person)
Delivered In-Person in LondonFlexible Dates
£495

Implementing Good Clinical Laboratory Practice

By Research Quality Association

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

Implementing Good Clinical Laboratory Practice
Delivered In-PersonFlexible Dates
£858 to £1,112

3 day mixed media mosaic playshop

By emmacavellart

Mosaic Summer School

3 day mixed media mosaic playshop
Delivered In-PersonFlexible Dates
£272

Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management

By Research Quality Association

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

Good Laboratory Practice for Study Directors, Principal Investigators, Study Staff and Management
Delivered In-PersonFlexible Dates
£851 to £1,105