Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 19 Points Development Level Develop
Course Information Join our comprehensive three-day training programme tailored for individuals seeking a foundational grasp of computerised system validation. This course equips participants with essential knowledge to effectively validate systems within their respective organisations for utilisation in GxP (GLP, GCP, GMP, GDP, and GPvP) environments. Attendees will also gain proficiency in auditing validated computerised systems, ensuring compliance with pertinent GxP regulations. Commencing with an overview of regulatory prerequisites and the system life cycle, the course transitions into practical aspects, centered around validating computerised systems and conducting subsequent audits. Engage in a dynamic blend of presentations, interactive discussions, and hands-on practical workshops throughout the course. This course will provide delegates with an understanding of the computerised system validation process, including: Definition of end user requirements Risk management, including supplier assessment and techniques for audit planning Validation planning and reporting Linking system development with good business practices Formal testing and qualification Understanding of data integrity and security issues How to assess system validation documentation to verify compliance. Is this course for you? IT professionals new to implementing computerised systems into regulated environments Quality professionals who monitor or audit computerised systems System owners, end users, tester and project staff. Tutors Tutors will be comprised of (click the photos for biographies): Nichola Stevens Director and Principal Consultant, Nuncius Compliance Solutions Ltd Barry McManus Consultancy Partner, Empowerment Quality Engineering Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome, Introduction and Course Objectives 09:45 Why Validate? Regulations and Guidance on Computerised System Validation Overview of the regulations and guidance applicable to CSV and their key expectations. 10:30 Break 10:45 The System Lifecycle The concept of the SLC and the key outputs from it. 12:00 Lunch 12:45 The Validation Process The approach to validation for different system types and a look at some of the key deliverables. 14:00 Project Introduction 14:15 Exercise 1 - User Requirements Capturing, agreeing and documenting the user requirements for a system. 15:15 Break 15:30 Exercise 1 - Feedback 16:00 Risk Management Risk management and its impact on validation. Identifying the deliverables required. Then group discussion on risk assessment for three systems. 17:00 Questions and Answers Answers to any outstanding questions from Day 1. 17:15 Close of Day Day 2 09:00 Supplier Assessment The different approaches to supplier assessment and the things to be considered when assessing a supplier. 10:15 Exercise 2 - Supplier Assessment Planning a vendor audit with a focus on the key validation deliverables. 11:00 Break 11:15 Exercise 2 - Feedback 11:45 Test Overview and Test Planning The different test phases, the purpose of each test phase and things to be considered when planning and reporting testing. 12:45 Lunch 13:30 Test Overview and Test Planning Continued. 14:15 Test Script Design, Execution and Review What a good test script looks like and the key things to consider when creating, executing and reviewing a test script. 15:30 Break 15:45 Exercise 3 - Creating a Test Script Create a test script based on user requirements created on Day 1. 17:15 Close of Day Day 3 09:00 Exercise 3 Feedback 09:30 Infrastructure Configuration and Qualification 10:30 Break 10:45 Validation Reporting Overview of the Validation Report and what should be included in it. 11:15 Maintaining the Validated State The procedures and records needed to ensure the system remains fit for purpose. 12:30 Lunch 13:15 Change Control Key concepts related to making changes to validated systems. 14:00 Data Integrity and Security How can we assure the integrity and security of our data. 15:15 Break 15:30 Course Objectives Summary and Panel Discussion A round up of key learning from the course. 17:00 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. CPD Points 19 Points Development Level Develop
Do you hear yourself saying the same thing over and over again? Do you want to bring some new skills to your role? If you have been in a sales role for some time it is easy to fall into a comfortable pattern. This workshop will help you incorporate advanced techniques drawn from NLP, behavioural science and social psychology into your existing skills. This course will help you: Use the consultative sales process to achieve more cross-sales Employ advanced rapport-building skills Assess the buying preferences of a customer Articulate the link between customer goals and needs Identify your customer's needs and wants Use advanced questioning techniques to gather information Resist the temptation to tell when it would be better to ask Identify communication preferences Given various scenarios, present a product to the explicit need of a customer Appreciate the impact of the language used during this stage of the sale and decide what language is appropriate with a variety of customers Handle objections positively Close the sale or gain commitment to further action 1 Introduction Aims and objectives of the training Personal introductions and objectives Self-assessment of existing sales skills Overview of content 2 Understanding yourself and your customers Personal communication style and what this means in a sales situation Wants versus needs What motivates people to buy Using social media tools such as LinkedIn Managing your portfolio to maximise sales Preparing to sell 3 The sales process Overview of the consultative sales process Review personal strengths and weaknesses as a salesperson Habits of top-performing sales people Common pitfalls Articulate sales goals 4 Building rapport 11 decisions that customers make in the first 9 seconds Spotting buyer communication preferences Building rapport with a wide variety of customers Dealing with emotions Keeping control 5 Questioning and listening Assumptions and how they trip us up Structured questioning Looking for cross-sales Honing your listening skills Identifying buyers' motivation Using summaries to move the customer forward 6 Presenting products and services to customers Choosing the right time to present Using features, advantages and benefits Tailoring your presentation of products and services to match buyer preferences and motivations 7 Gaining commitment When to close Dealing with difficult customers 5 things to avoid when handling a customer objection 8 Managing your business The link between service and sales Using customer surveys Winning back lost business 9 Putting it all together Skills practice Personal learning summary and action plans
Developing the high performing team takes time and effort. But above all, it requires an understanding of the dynamics of high performing teams. This programme helps managers and leaders understand what high performing teams do and how they do it. It focuses on enabling managers to see their teams from different perspectives, allowing them to adapt their styles to maximise team outputs. A core theme is the need for managers of teams to 'hold up the mirror' to themselves and to see themselves as a leader of people, to reflect on how others see them and to modify their style accordingly. This programme will help managers / team leaders: Analyse the constituents of a 'high performing' team Apply essential influencing techniques Use a range of communication techniques to support effective teamwork Create and articulate team vision Generate common values Assess team effectiveness and take/recommend the appropriate actions Make more efficient use of team time Understand and agree on techniques to manage conflict Define and implement team meeting protocols that will facilitate team effectiveness Use the Prime Focus model to create the environment and framework for a high performing team Draft your team strategy to take them to the next level Day 1 1 Welcome and introduction Participants are welcomed to the programme and invited to share their personal objectives and people challenges Participants are given an action plan template to complete throughout the workshop 2 Your team The concept of 'positive intention' The difference between a team and a high performing team Assess your team effectiveness What is your 'interference'? 3 The team environment Setting the scene Building rapport Active listening Team goals and role profiling 4 Your style Tuckman model of team stages - how do you manage each stage? Team standards and goals Your team vision 5 Effective team meetings Influencing in team meetings How to make them interesting and relevant The pure role of the chair Day 2 1 Effective communication techniques Giving and receiving feedback Your communication style How to adapt, pace and lead to build rapport The Mehrabian theory of communication 2 How to manage conflict What is conflict? What is your default conflict approach? Tools and tips for managing conflict Practice sessions 3 Team skills Undertake a team skills analysis Types of team member Motivating team members Reframing situations 4 Setting your strategy Seeing the bigger picture The Prime Focus Model Your strategy for success Articulating your strategy Action plans revisited
About this Training Course Managed Pressure Drilling (MPD) offers opportunities to improve safety and efficiency in drilling, and it is increasingly recognised by operators and regulators. MPD aims to cost effectively resolve chronic drilling problems that contribute to non-productive time. This 3 full-day course provides participants with an understanding of the MPD techniques and equipment. The course starts with the design requirements for an MPD operation. It covers all MPD methods, including constant bottom hole pressure and mud cap drilling operations. It also includes all of the rig types - both onshore and offshore - and MPD. MPD equipment is presented in detail and the design aspects of the well are also examined. Training Objectives This course aims to provide participants with a good understanding of the various aspects of managed pressure drilling. It also enables participants to gain knowledge of planning MPD operations, type of equipment and the equipment requirements for both onshore and offshore and MPD operations. At the end of the course, participants will be able to: Understand the variations in MPD Design MPD operations for various techniques Understand the engineering requirements of MPD Define MPD equipment requirements Understand operational and well control aspects of MPD Target Audience This course is designed for engineers, managers and service providers who are about to use MPD techniques and are trying to better understand the associated complexities and challenges surrounding MPD. Trainer Your expert course leader was born and raised in Nijmegen, Netherlands. He holds an MSc in Drilling Engineering from The Robert Gordon University in Aberdeen and has over 39 years of oilfield experience. He started in the industry back in 1977 as a Mud logger before becoming a wellsite drilling engineer in 1980 working mainly in the Middle East and West Africa. In 1988, he joined Shell in in the Southern North Sea. In 1995, he joined Smedvig in Norway and worked on a number of deepwater wells as well as on underbalanced drilling operations. In 1999, he started Leading Edge Advantage in Aberdeen and worked in coiled tubing, underbalanced and managed pressure drilling. In 2004, he joined Weatherford as Regional Engineering Manager in Singapore and developed the first ultra deepwater MPD systems. In 2010, he joined SPT Group specializing in well control and hydraulics modelling. SPT Group was later acquired by Schlumberger in 2012. At Schlumberger, he was Drilling Adviser, with a focus on well control, relief well planning and MPD. During that time, he was also an instructor for NExT teaching numerous well engineering courses. In 2015, he joined Wild Well as Engineering Manager in Asia and in February 2017, he became an independent consultant concentrating on provision of drilling engineering training. He has written and presented numerous papers and authored several chapters in the SPE Advanced Technology books. He is an active committee member and speaker on numerous SPE Workshops around the world. POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations
Join Debbie Tomkies for this relaxed, fun workshop in Altrincham. You’ll be making a beautiful needle felted landscape picture in your choice of colours and designs. Suitable for all levels.
About this Virtual Instructor Led Training (VILT) Hydrogen will play an increasingly critical role in the future of energy system as it moves forward to supplement and potentially replace fossil fuels in the long run. Offshore wind offers a clean and sustainable renewable resource for green hydrogen production. However, it can also be volatile and presents inherent risks that need to be managed. Even though offshore production of hydrogen has yet to achieve a high state of maturity, many current projects are already dealing with the conditions and effects of offshore production of hydrogen and are grappling with the technological requirements and necessary gas transportation with grid integration. This 2 half-day Virtual Instructor Lead Training (VILT) course will examine the technological options for on-site production of hydrogen by electrolysis (onshore or offshore directly at the platform) as well as the transport of hydrogen (pipeline or ship). This VILT course will also explore the economic considerations and the outlook on future market opportunities. There will be exercises for the participants to work on over the two half-days. This course is delivered in partnership with Fraunhofer IEE. Training Objectives By the end of this VILT course, participants will be able to: Understand the technological attributes and options for green hydrogen production based on electricity from offshore wind. Explore the associated economic analysis for offshore wind hydrogen production, including CAPEX, OPEX, LCOE and LCOH Identify the critical infrastructure and technical configuration required for offshore green hydrogen including transportation networks and grid connectivity Learn from recent findings from current Research & Development projects concerning the differences between onshore and offshore hydrogen production. Target Audience This VILT course is intended: Renewable energy developers and operators Offshore oil & gas operators Energy transport and marine operators Energy policy makers and regulators IPPs and power utilities Training Methods The VILT course will be delivered online in 2 half-day sessions comprising 4 hours per day, including time for lectures, discussion, quizzes and short classroom exercises. Course Duration: 2 half-day sessions, 4 hours per session (8 hours in total). Trainer Trainer 1: Your expert course leader is Director of Energy Process Technology Division at the Fraunhofer Institute for Energy Economics and Energy System Technology, IEE. The research activities of the division link the areas of energy conversion processes and control engineering. The application fields covered are renewable energy technologies, energy storage systems and power to gas with a strong focus on green hydrogen. From 2006 - 2007, he worked as a research analyst of the German Advisory Council on Global Change, WBGU, Berlin. He has extensive training experience from Bachelor and Master courses at different universities as well as in the context of international training activities - recently on hydrogen and PtX for partners in the MENA region and South America. He holds a University degree (Diploma) in Physics, University of Karlsruhe (KIT). Trainer 2: Your expert course leader is Deputy Head of Energy Storage Department at Fraunhofer IEE. Prior to this, he was the director of the Grid Integration Department at SMA Solar Technology AG, one of the world's largest manufacturers of PV power converters. Before joining SMA, he was manager of the Front Office System Planning at Amprion GmbH (formerly RWE TSO), one of the four German transmission system operators. He holds a Degree of Electrical Engineering from the University of Kassel, Germany. In 2003, he finished his Ph.D. (Dr.-Ing.) on the topic of wind power forecasting at the Institute of Solar Energy Supply Technology (now known as Fraunhofer IEE) in Kassel. In 2004, he started his career at RWE TSO with a main focus on wind power integration and congestion management. He is Chairman of the IEC SC 8A 'Grid Integration of Large-capacity Renewable Energy (RE) Generation' and has published several papers about grid integration of renewable energy source and forecasting systems on books, magazines, international conferences and workshops. Trainer 3: Your expert course leader is Deputy Director of the Energy Process Technology division and Head of the Renewable Gases and Bio Energy Department at Fraunhofer IEE. His work is mainly focused on the integration of renewable gases and bioenergy systems into the energy supply structures. He has been working in this field since more than 20 years. He is a university lecturer in national and international master courses. He is member of the scientific advisory council of the European Biogas Association, member of the steering committee of the Association for Technology and Structures in Agriculture, member of the International Advisory Committee (ISAC) of the European Biomass Conference and member of the scientific committees of national bioenergy conferences. He studied mechanical engineering at the University of Darmstadt, Germany. He received his Doctoral degree on the topic of aerothermodynamics of gas turbine combustion chambers. He started his career in renewable energies in 2001, with the topic of biogas fired micro gas turbines. Trainer 4: Your expert course leader has an M. Sc. and she joined Fraunhofer IEE in 2018. In the Division of Energy Process Technology, she is currently working as a Research Associate on various projects related to techno-economic analysis of international PtX projects and advises KfW Development Bank on PtX projects in North Africa. Her focus is on the calculation of electricity, hydrogen and derivative production costs (LCOE, LCOH, LCOA, etc) based on various methods of dynamic investment costing. She also supervises the development of models that simulate different PtX plant configurations to analyze the influence of different parameters on the cost of the final product, and to find the configuration that gives the lowest production cost. She received her Bachelor's degree in Industrial Engineering at the HAWK in Göttingen and her Master's degree in renewable energy and energy efficiency at the University of Kassel. POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information about post training coaching support and fees applicable for this. Accreditions And Affliations
This workshop will provide participants with the insight and skills to be more effective business networkers, face-to-face and online. The approach taken is to build on the strengths people already have and their successes. It is easier to develop what you already have than to try and develop skills that do not come easily. Being yourself is the most effective tool for business networking and building relationships. This course will help those attending: Appreciate the importance of networking, and different forms of networking Understand the dynamics of communication that are specific to networking Become more confident and assured when 'working' a room Improve their influencing skills, especially with people who are experts and in positions of authority 'Sell' themselves and promote their company Identify and manage their profiles using online social networking sites Use effective follow-up to maintain active contacts and connections Select the correct networking groups, clubs and events Create their own personal network 1 The importance, and different types, of networking Personal objectives and introductions Test networking session Examples of the importance, purpose and format of various types of networking, and benefits you can expect 2 How to work a room - preparation and strategy Three things to know before you attend any event Non-verbal communication and art of rapport Breaking the ice - worked examples with practical demonstration 3 Communication dynamics in networking - the power of the listening networker Why it is better to listen than talk Effective questioning and active listening Creating a natural and engaging conversation, 1-2-1 and in a larger group 4 Assumptions when networking How to use the 'instant judgement' of others to your advantage What assumptions are you making? How to keep an open mind 5 Business networking etiquette Meeting and greeting at a business networking event - approaching complete strangers and introducing yourself Socialising: joining and leaving groups easily Making a good first impression in 30 seconds The use of status when networking 6 Making connections Asking for cards, contact details and referrals Gaining a follow-up commitment Some tips and tricks 7 Business networking rehearsals Practice sessions 8 Personal business networking online Overview of different types of networking sites - there is a lot more out there than just Facebook! Examples of creating an effective profile Using social networking effectively - case studies and application 'Advanced' applications - blogs, articles, twitter, feeds, etc. Online demonstration and examples 9 Building relationships - follow-up and follow-through Maintaining a good database Developing a contact strategy with different types and levels of contact How to analyse your contact base
Conflict is a word that conjures up many emotions. It is something that most people would prefer to avoid, if possible. Work can be an emotive place. Positive relationships can make your life at work exciting, motivating and challenging, whilst relationships that do not hold value to you could make your life very difficult and stressful, especially if there is conflict between you and your manager. This course is essential for people who want to understand where conflict can be used to positive effect and how to manage conflict in your working relationships and see it as something positive that can stimulate the environment. Research has shown that relationships at work are an extremely high motivational factor, and for a lot of people it has a higher importance that salary! Therefore, it is essential that we invest in relationships and search out new ways to make them better in order to have a more positive influence on our surroundings. By understanding why other people are in conflict we can manage the conversation a lot better, with outcomes managed more effectively so the 'conflict' will add value to the organisation. This participative event will cover a wide variety of exercises and personal stories, and leave course participants with a clear strategy to identify when they are in conflict with someone and how they will structure their approach to get to a satisfactory outcome. This is a workshop that targets anyone where conflict needs to be managed and cannot seem to resolve it, whether internally or externally. At the end of the day, participants will: Know their key relationships and the strength of those relationships Complete the Strengths Deployment Inventory (SDI) to identify where you deploy your strengths Understand what is important to you and your key stakeholders Know how motivational value systems can influence behaviour Tailor your communication style to match that of your opposite party Know conflict strategies to resolve conflict in others Learn to be more assertive when challenging Achieve key personal, departmental and organisational objectives 1 Where are you now? How effective are your current working relationships? Can I work effectively without the input from others? Who do you need to be a success? 2 The Strengths Deployment Inventory (SDI) Completion of the SDI questionnaire An understanding of the theory A 'trip around the triangle' Predicting relationship interaction Your scores and what they mean in your relationships 3 Conflict theory What is conflict? The 3 flags of conflict What are your conflict triggers? Your conflict scores plotted The conflict sequence 4 Conflict resolution strategies Early warning signs Most productive behaviours Least productive behaviours Preventable / unwarranted conflict Review of the dynamic triangle Review of the day, personal learning and action planning
The "Foundations of Immunisation and Vaccines for Non-Registered Practitioners" course is fully compliant with the National Minimum Standards and Core Curriculum for Immunisation Training and is designed to equip non-registered healthcare professionals with a solid understanding of immunisation concepts, vaccine administration, and the importance of vaccination in public health.