Course Information This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks. Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings. Is this course for you? Ideal for professionals engaged in GMP across various sectors, including: Research and Development (R&D) Contract Manufacturing Organisations Manufacturing Units Quality Control (QC) Laboratories Auditing Roles. What will you learn? Event objectives - by the end of the course, delegates shall: Have an awareness of the basic requirements of GMP Be aware of UK and EU GMP Rules and Guidance and relevant publications Understand the roles and responsibilities associated with GMP Be able to contribute to and maintain quality documentation Have a basic understanding of product lifecycle and manufacturing Understand the requirements of GMP in the QC laboratory context Have a basic understanding of risk management and mitigation principles Understand the need for quality systems and quality assurance activities Be aware of common regulatory findings. Learning outcomes: delegates will be able to: Implement their role within GMP with confidence and knowledge of the principle requirements Contribute effectively to the GMP quality system and their organisation’s compliance Comprehend where their organisation’s activities sit within the larger GMP arena Know where to seek further information within the published rules and guidance, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 09:30 Introductions and Scope of the Course Understand the group requirements and the tutor's background and experience. 09:45 Background and Regulatory Environment Setting the scene, understanding the context, key legislation. 10:30 Principles of GMP Key points and requirements. 11:15 Break 11:30 Personnel and Responsibilities Management and staff, duties and accountabilities. 12:00 Overview of GMP Manufacturing Basics of the product life cycle. 12:30 Lunch 13:15 Risk Management Workshop Practical exploration of risk and mitigation activities. 14:30 QC Laboratories Activities and practicalities. 15:15 Break 15:30 Compliance Quality Assurance and Self Inspection. 16:15 Question Time A chance for questions on the practicalities of GMP. 16:30 Close of Course Extra Information 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 7 Points Development Level Learn
Project Management for Non-Project Managers: In-House Training Individuals who are involved in projects (commissioning, supporting, sponsoring, etc.) may often be unfamiliar with project management. A basic understanding of project management is essential for non-project managers, who are critical stakeholders contributing to project success. This awareness course uses A Guide to the Project Management Body of Knowledge (PMBOK® Guide) and other sources to introduce you to project management vocabulary, concepts, and techniques. It also provides insights into the realities of being a project manager, and opportunities to explore how you can positively impact projects in your own role. What You Will Learn At the end of this program, you will be able to: Identify the benefits of project management Use standard project management terminology Describe characteristics of successful projects, project managers, and high-performing teams Explain various project stakeholder roles, their responsibilities, and the fundamental project management processes Recognize how agile / adaptive practices are useful for certain project life cycles Create a personal action plan for how to support real-world projects within a non-PM role Getting Started Introductions Course structure Course goals and objectives Foundation Concepts Project management overview Strategic value of project management Defining project success Project life-cycle models and governance Project roles and responsibilities Project Initiating and Planning Initiating the project Defining project requirements and scope Developing the project schedule and budget Project Risk Management, Executing, Monitoring, and Closing Understanding, evaluating, and adjusting for risk Honoring the baseline and executing the project Monitoring and controlling the project Closing the project Project Interpersonal Processes Project communication Project team development Conflict management
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
Duration 5 Days 30 CPD hours This course is intended for This course is intended for novice database developers, database administrators, Business Intelligence developers, report creators, and application developers who have an understanding of relational database concepts and have basic Windows navigation skills. Overview Create single table SELECT queries Create multiple table SELECT queries Filter and sort data Insert, update, and delete data Query data using built-in functions Create queries that aggregate data Create subqueries Create queries that use table expressions Use UNION, INTERSECT, and EXCEPT on multiple sets of data Implement window functions in queries Use PIVOT and GROUPING SETS in queries Use stored procedures in queries Add error handling to queries Use transactions in queries This five-day instructor-led course is intended for IT professionals who wish to use the Transact-SQL language to query and configure Microsoft SQL Server. Students are typically database developers and database administrators, but might also be Business Intelligence developers, report creators, or application developers. In this course, students learn how to query single tables, join data from multiple tables, filter and sort data, modify data, use procedures and functions, and implement error handling. Prerequisites Basic understanding of relational databases. Basic Windows knowledge. Module 1: Introduction to Transact-SQL What is Transact-SQL The SELECT statement The WHERE clause Sorting results Calculations CASE expressions Module 2: Joining tables with Transact-SQL The JOIN clause Inner joins Outer joins Self joins and cross joins Module 3: Filtering and sorting results Implement the ORDER BY clause Filter data with the WHERE clause Limit the number of rows returned by a query Implement NULL logic Module 4: SQL Server data types Understand data types Implement string data types Implement temporal data types Module 5: Inserting, updating and deleting data Insert new records Update existing records Delete data Module 6: Using SQL Server functions with Transact-SQL Understand function types in SQL Server Convert data using functions Implement logical functions Work with NULL data using functions Module 7: Aggregating data with Transact-SQL Implement aggregation in SQL Server Group records in SQL Server Filter aggregated data Module 8: Implement subqueries with Transact-SQL Implement scalar and multi-valued sub-queries Implement correlated subqueries Implement existence checks with subqueries Module 9: Create queries that use table expressions Create views Create table-valued functions Implement derived tables Implement common table expressions Module 10: Use UNION, INTERSECT, EXCEPT and APPLY on multiple sets of data Write queries with the UNION operator Write queries with the INTERSECT and EXCEPT operators Write queries with the APPLY operator Module 11: Implement window functions in queries Understand window functions Impement window functions Module 12: Use PIVOT and grouping sets in queries Implement PIVOT in queries Implement grouping sets in queries Module 13: Use stored procedures in queries Query data with stored procedures Interact with stored procedures using input and output parameters Write simple stored procedures Pass dynamic SQL to SQL Server Module 14: Implement programming features in Transact-SQL Understand T-SQL programming elements Implement loops and conditions in T-SQL queries Module 15: Add error handling to queries Understand SQL Server error handling Implemet structured exception handling Module 16: Use transactions in queries Understand database transactions Implement transactions in T-SQL
You have the pieces of the Leadership Puzzle; the knowledge of child Development, the knowledge of best practise, the knowledge of health and safety plus much more. Now let's use these pieces of knowledge to help you connect and lead a team to excellence.
Course Information Join us for a comprehensive refresher focusing on crucial Good Laboratory Practice (GLP) requirements, including an emphasis on data integrity, recent developments, and emerging trends gleaned from MHRA inspections. The programme dives into specific domains such as risk assessment, OECD guidance on sponsor influence, and the advisory from OECD on QA. Additionally, delegates can benefit from a dedicated GLP clinic, facilitating discussions on understanding and upholding GLP compliance. Is this course for you? This course is tailored for study directors, principal investigators, test facility management, and QA professionals seeking to refresh their knowledge and responsibilities within the GLP framework. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Registration, Welcome and Introduction 09:20 Development of Good Laboratory Practice A reminder of the history of GLP, its current scope and application, with a synopsis of current UK, European and international standards. 09:50 Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA A reminder of the roles and responsibilities with regard to the GLP management and oversight of the Test Facility and the management and control of the study, as defined by GLP. 10:30 Break 10:45 Workshop 1 Workshop 1 Roles and responsibilities 11:15 Influence of Sponsors The published OECD Position Paper No. 21 regarding Possible Influence of Sponsors on conclusions of GLP Studies is reviewed and discussed. 11:45 Data Integrity The fundamentals of data integrity according to the OECD Guidance No. 22 on Data Integrity is discussed along with the responsibilities of Study Director, Test Facility Management, and study staff in ensuring the integrity of the GLP study data. 12:30 Lunch 13:15 Quality Assurance and GLP OECD Advisory No. 23 (Revision of OECD No.4)- A walk through of the changes to the OECD Guidance on the role and activities of Quality Assurance 13:45 Quality Improvement Tools and GLP The tools that might be considered for GLP and their role and operation when used in Test Facilities- OECD Position Paper No.24 published July 2022 14:15 Workshop 2 Workshop 2 Change control 14:30 Risk Assessment How should we assess risk and how can we use the process to assist in evaluation audit findings? 15:00 Break 15:15 Current hot topics in GLP Explore the current issues in Industry and trends /types of Regulatory inspection findings 15:50 GLP Clinic An opportunity to discuss any other issues regarding understanding and maintaining GLP Compliance. 16:30 Close of Course Extra Information 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 7 Points Development Level Learn
Overview This course will define the scope of work, project goal, project plan, project phase, sequencing and phase relationship Project Planning & Budgeting will provide participants with a demonstrated set of methods, processes, tools and techniques to cultivate a systematic and dynamic project plan to certify progressive monitoring control and reporting of the project cost.
Overview Tendering is a process on which a lot of money relies. When a tender is issued and published, winning that contract is completely depended on how deeply you understand the tender, the key areas of the tender along with how much in-depth knowledge you have about the potential client's need and how you can provide your service to those needs.
Overview EPC (Engineering, Procurement and Construction) is a very challenging area and is very competitive as well. Companies dealing with large and complex EPC projects are more often get involved in mitigation by complex contract laws and management that lead to huge financial losses. It is very important to Know-how EPC contract laws, and their commercial and financial aspects to gain skills and the ability to deal with complex contract laws and reduces the risk.
Overview The course focuses on topics such as the fundamental concepts of auditing and quality management, principles of internal and external audit, auditing processes and tools, principles and practice of root cause analysis, communication and people skills, and other related topics. Students who successfully complete this course will gain the essential knowledge and skills necessary to become successful auditors and work with confidence to improve the processes in their organizations.