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
This workshop is very practical in its nature and aims to give delegates an opportunity to not only learn about the key aspects of successful bid writing, but to also put them into practice. The workshop helps delegates understand what is most important to buyers and how to successfully convey they proposition to them. 1 Welcome and introductions 2 The mindset of successful bid writing The mindset needed for successful bid writing Thinking from the buyer's perspective and not your own 3 Decision making The way buyers make decisions - rational and emotional Understanding buying motives Looking at how to present ideas against those motives The idea of cognitive fluency How to pitch an idea in a way that leads to a positive decision 4 To bid or not to bid? Writing a bid is a big commitment; a clear understanding of the chances of winning is required Understanding of the implications of winning and the impact it will have on the organisation 5 Understanding your value proposition Framework to help identify unique proposition and how that fits in with the requirements of the bid 6 The tender process Understanding the process to enable a successful chance of winning the bid Different types of tender processes Evaluation of criteria and the impact on bid writing 7 Writing skills Different ways of writing and structuring bids to ensure their messages gets across well in a way that will be looked on favourably by the buyer 8 Summarise 9 Close
We all tend to have challenges throughout our lives that cause varying levels of pressure. It is healthy and essential that people experience such challenges because up to a certain point an increase in pressure improves performance and quality of life. Too much pressure can be harmful and affect our health and wellbeing. This participative half-day workshop will explore the causes and impact of stress and provide an opportunity to learn some new ideas and techniques to cope with it. Practical tasks and exercises will be used to promote discussion and participants will be encouraged to share their own experiences and approaches. By the end of the workshop participants will be able to: Understand the causes and symptoms of stress and how to spot them Become more aware of personal habitual behaviours and approaches that get in the way of dealing with stress productively Learn ideas and approaches that help you to cope with the thoughts, emotions and physical feelings that happen in stressful and difficult situations Review and evaluate learning and have an action plan to take back and put into practice at work 1 Welcome, introductions and objectives Breaking the ice 2 Stress Its sources and effects on you Defining stress, its signs and symptoms 3 Exploring your 'default' habits Their consequences in stressful situations 4 Dealing with perception Strategies and approaches for coping with stress 5 Setting goals with positive outcomes Review and evaluation of learning Action planning
Logistics for Traders: Importance, Role and Benefits. This session will look at how logistics is a critical component within the supply chain but is often overlooked.
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This very practical workshop is designed to enable participants to improve the impact, clarity and accuracy of their business documents - both internal and external.: This workshop will help participants: Identify the purpose of writing their documents - to themselves and to their readers Recognise and meet the needs of their readers Plan documents systematically and improve the layout, flow and structure Express the content more clearly, concisely and correctly Adapt the tone and style of writing to the circumstances Proof-read and edit work effectively, using formal marks and techniques Improve visual layout, format and appearance 1 Course objectives Welcome and Introductions The problems now - group discussion 2 Writing better business documents What points to highlight / exclude Starting off Introductions Conclusions Executive summaries 3 Rules and standards George Orwell's famous maxim Why write? - clarifying your aims and objectives A seven-step method for better preparation The three-stage process for writing well Grouping information for your reader 4 Proof-reading and editing The difference between proof-reading and editing Proof-reading methods and strategies Proof-reading marks and techniques Training your eye for detail Knowing what to look for 5 Effective editing Grammar and English standards Words - usage and spelling Sentences - units of thought Paragraphs - themes Punctuation - spotting and correcting common errors Say what you mean - active v passive language 6 How's your English? Grammar quizzes and punctuation test Spotting spelling errors Rephrasing jargons and clicheÌs Common error's and mistakes 7 Document layout House style Use of white space Fonts and effects 8 One-to-one workshops These are practical sessions with one-to-one consultation with colleagues and the trainer They are held at key points to consolidate the learning from different sessions 9 Course summary Summary of key points Action plans
This very practical and focused one-day workshop enables end-users, technical experts, proponents, internal customers and other key stakeholders to work with procurement and contracting to develop effective specifications and scopes of work, to ensure fit-for-purpose outcomes. The programme empowers participants to collaborate with all key stakeholders. This workshop will help participants: Understand the importance and value of clear and effective specifications Differentiate between the different methods of creating specifications and when to apply them Develop robust specification templates to ensure consistency Understand the use of appropriate language (critical to creating effective specifications) Appreciate the need to develop specifications in cooperation with stakeholders Make use of techniques such as value analysis and value engineering to define 'fit for purpose' in the context of creating effective specifications Embed key KPIs into the specification to ensure delivery Manage and mitigate legal and contractual risks in the specification 1 Introduction Learning outcomes Learning styles Plan for the day 2 The importance of effective specifications Scopes of work Impact of poor scopes of work Examples of costly errors 3 The critical role of language Terminology in creating effective specifications and scopes of work Problems of communication Lack of detail or too prescriptive 4 Encouraging cooperation Technical and commercial experts with responsibility for developing robust effective specifications and scopes of work Managing stakeholders' expectations Working with contractors 5 Types of specification Exploring and using the various approaches to the development of appropriate specifications and scopes of work Output Performance Technical Functional Solutions-based 6 The role of value analysis Value engineering in the process of developing scopes of work and specifications 7 Specifications and contracts The legal and contractual impact of poor specifications and scopes of work How to embed scopes of work and specification outputs into tender and quotation documents 8 Specifications as a management tool Developing KPIs and SLAs framed around robust effective specifications and scopes of work Negotiating with contractors Negotiating with stakeholders
This training day will help managers explore what they need to do to create a motivating environment at work and learn some theory, tools and ideas to inspire motivation at individual and team level. Motivation is a key factor in effective people management and successful team performance. It involves engaging and inspiring your people and developing them in such ways as to improve their effectiveness and thus have a greater benefit to customers. It can also involve having tough conversations with those who do not seem to be motivated. By the end of the workshop participants will be able to: Identify key motivating factors at work and learn and create ideas to better engage staff Learn a conversation tool to use for challenging discussions Explain their role in motivating staff and understand a range of techniques and approaches to use in the workplace Review learning and have an action plan to take back and implement at work 1 Welcome, housekeeping, objectives Breaking the ice Setting personal objectives 2 Group work: identifying personal motivators and where they come from 3 Defining motivation The characteristics of a motivated team Input and group discussion 4 Factors impacting on motivation at work Using pre-work to identify challenges, hotspots and obstacles Feedback in plenary Exploring the benefits of motivation that address current challenges and agreeing outcomes for change 5 Commitment vs. compliance - organisational engagement and the manager's approach to buy in 6 Team challenge task using a theory about motivation Trainer input and review in plenary 7 Group task - complete a plan for individuals identified in pre-workshop task 8 Skill / will - a motivation tool: trainer input, followed by tasks that are assessed and discussed in peer groups 1-2-1 feedback task on approaches and plans to be taken back and used at work Feedback and plenary review 9 DEAL - a conversation tool: how to construct a conversation plan about motivation with an individual Peer professional 1-2-1s to practice the discussion planned and gain feedback 10 Review, evaluation and action planning
Reiki level 1, is the beginners level. Even at this level, you have access to Reiki energy and the ability to use Reiki energy to heal yourself and others. Level 1 is open to anyone. The focus during Level 1 is on opening the energy channels on a physical level, allowing the practitioner to connect to the universal life force energy; you will receive full ongoing support to ensure you feel fully confident and consistent in your practice. I believe this means more practitioners will continue to use reiki daily, rather than be attuned and then never use it again.