93 History courses in St Neots

Course Information A must-have programme for Quality Assurance auditors stepping into or honing their role within a Good Laboratory Practice (GLP) environment, this course offers invaluable, expert guidance for crafting a robust and efficient GLP audit programme. What will I learn? A solid regulatory foundation underpinning quality assurance activities Clarity on the roles of Quality Assurance, management, and study director within the framework of Good Laboratory Practice principles Enhanced efficacy in inspections and audits Heightened compliance with Good Laboratory Practice standards for your facility Unique insights into governmental monitoring activities within the GLP sphere. This course is structured to encourage delegates to Discuss and develop ideas Solve specific problems Examine particular aspects of GLP. Tutors Tutors will be comprised of (click the photos for biographies): Cate Ovington Director, The Knowlogy Group Ltd Jane Elliston Senior Quality Assurance Auditor, Battelle UK Shona Ross Head of QA, Tower Mains Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:15 Good Laboratory Practice Standards and Regulations An insight into the background and history of Good Laboratory Practice. 09:45 Principles of Quality Assurance What is the role and responsibilities of QA in GLP. Maintaining the independence of QA and what is an audit. 10:30 Break 10:45 Standard Operating Procedures GLP requirements and QA involvement. 11:30 Study Plans GLP requirements and QA involvement. 12:05 QA Programme Risk based programme, what are study, process and facility audits. 13:00 Lunch 14:00 Inspections Attitudes, techniques and attributes. 14:40 Workshop 1 - Facility and Process Inspections An exercise in inspection planning and preparation for inspections. 15:15 Break 15:30 Workshop 1 - Feedback 15:45 The Auditor and Audit Conduct Attitudes, attributes and techniques. 16:30 Panel Session An opportunity for delegates to put questions to the panel of speakers. 17:15 Close of Day Day 2 09:00 Workshop 2 - A Mock Audit 10:45 Break 11:00 Workshop 2 - Feedback 11:30 Auditing the Study Report Techniques and methods for the QA audit of the study report. 12:00 Record Keeping and Data The impact of GLP on data and records management. 12:40 Lunch 13:25 Data Integrity A look at the OECD GLP guidance document; the expectations of the regulators and the involvement of QA - Where QA adds value. 14:15 Workshop 3 - Amendments to Study Plan and Deviations from the Plan What are they? What is the difference between them? How are they controlled? 15:00 Workshop 3 - Feedback 15:15 Break 15:30 Regulatory Compliance GLP Monitoring Authority monitoring for compliance with Good Laboratory Practice. 16:15 Panel Session An opportunity for delegates to put questions to the panel of speakers. 16:45 Close of Course Extra Information Face-to-face course Course Material Course material will be available in PDF format for delegates attending this course. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course. The material will be emailed in advance of the course and RQA will not be providing any printed copies of the course notes during the training itself. Delegates wishing to have a hard copy of the notes should print these in advance to bring with them. Alternatively delegates are welcome to bring along their own portable devices to view the material during the training sessions. Remote course Course Material This course will be run completely online. You will receive an email with a link to our online system, which will house your licensed course materials and access to the remote event. Please note this course will run in UK timezone. The advantages of this include: Ability for delegates to keep material on a mobile device Ability to review material at any time pre and post course Environmental benefits – less paper being used per course Access to an online course group to enhance networking. You will need a stable internet connection, a microphone and a webcam. CPD Points 14 Points Development Level Learn

Course Information 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. 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This is an essential programme for managers or members of staff (or students) who need to be able to read and summarise information on screen faster and more effectively. The session focuses on the different types of reading style and encourages better retention of written material through the use of specific speed-reading techniques. By the end of this programme participants will be able to: Explain the principles of speed reading Understand the barriers to reading Use different reading styles according to the information being read Read more effectively from tablet and computer screens Co-ordinate eye movements better Minimise any poor reading habits Increase reading speed by over 50%, without losing comprehension Improve retention of information using specific techniques The programme focuses on how to maximise reading from electronic devices by exploring techniques which will reduce eyestrain and improve reading effectiveness. The session also explains different types of reading styles and how to learn new, positive reading habits. 1 An introduction to speed reading The history of speed reading Assumptions about reading The process of reading Schema and its influence on interpretation Eye/brain relationship How our brain processes written information 2 Minimising barriers to reading Understanding eye tics Mouthing The influence of different light sources Body clocks and making use of natural patterns 3 Reading styles Importance of choosing the right reading style Speeds and their influence on retention Reading for pleasure Proof reading Scanning Skimming Reading for retention SQRW principles 4 Reading from electronic devices The challenge of reading from screens Importance of breaks and proper display screen evaluation Calibrating screens and background colours Formatting documents Using eye guides

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Reliability Centred Maintenance (RCM) is commonly used to help establish safe minimum levels of maintenance, determine changes to operating procedures and help establish maintenance regimes and plans. Successful implementation can result in cost savings, machine uptime and improved risk management. But the devil's in the detail - how can you achieve these benefits and successfully implement RCM in your organisation? This programme will help you do just that. Note: this is a purely indicative outline. The content, duration, objectives and material used can all be adapted to match your specific requirements. To provide a better understanding of RCM, particularly: What, why, how and who? Opportunities and benefits Risks Cost effectiveness Note: this is a purely indicative outline. The content, duration, objectives and material used can all be adapted to match your specific requirements. 1 What is maintenance? Why maintain? Traditional maintenance methods Common current practices and trends 2 What is Reliability Centred Maintenance? Its history Its development Current usage Where can it be cost-effective? 3 How does it work? Basic features Key criteria Maintenance options Key outcomes 4 Making the business case and preparing the strategy Identifying and quantifying current risks Identifying and quantifying current costs Motivating decision-makers Identifying and empowering those who have to deliver the results Educating / gaining buy-in from interested parties 5 Implementation Identify business functions Prioritise functions Verify correct usage Identify failure modes Identify the consequences of failure Understand the failure process Specify the appropriate maintenance action(s) 6 Ongoing requirements Monitoring Recording Analysis Continuous re-evaluation 7 Open discussion Sharing experience and addressing specific issues of interest to participants Course review Close

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When managers have too many decisions to make, it can have a serious impact on the speed and efficiency of the organisation. When those decisions are commercial ones, the results can wreak havoc with the bottom line. Often the problem arises when those below them or in operational areas of the organisation aren't equipped or allowed to make a decision for themselves. Issues get passed back up and that wastes time. This programme provides a solution, giving your entire team the skills to: And most importantly, they'll be able to do this in line with the broader aims and commercial objectives of the business. By the end of the programme participants will be able to: Fully appreciate the importance of effective decision-making in business Use the five-step 'Stop, Think, Act!' decision-making process Stop leaping to conclusions Really understand the situations and decisions they are dealing with Identify good options Evaluate those options Make decisions and then put them into action Apply these tools and techniques to all their decisions in future 1 Understanding the business we work in What are the critical factors in our business? What is the SWOT analysis for our business? 2 Understanding what decision-making is 3 Background Culture of 'having to be doing' To change things we have to think about it! We are paid to make decisions! 4 Recognise the opportunity to make a decision 5 The 'Stop, Think, Act!' technique 6 STOP! Recognise the opportunity to make a decision Don't leap to conclusions Get ready to think Initial questions:Is this my decision? (Do I have the authority?)Who is this going to affect? (Do they need to be included?)When do I need to make the decision? (What's the timeline?) 7 THINK! The 3 Cs - making sure we understand the decisions we have to make What is the context of this decision?What is the overall situation?Why is this decision important?What do we need to achieve?What will success look like? Do I have clarity about the decision I need to make?Can I write it down?Can I express it clearly in two sentences? What are the criteria?What are the critical commercial factors that we will use to select our options?What will we use to measure the business success? 8 ACT! Identifying options What data do I need to collect?Issues with today's overloadIdentifying what will help you Select optionsHow many options?Must match your criteriaMust achieve success'Decision compass' exercise Analyse optionsTabular methodRisk analysis (likelihood v effect)Head, heart and gut (is there any organisational history/bias that we are up against?) Making your decision Taking it to actionFirst actionsPlanning how to make it happen