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Root Cause Analysis (RCA) is used to analyse the root causes of focus events with both positive and negative outcomes, but it is most commonly used for the analysis of failures and incidents. Causes for such events can be varied in nature, including design processes and techniques, organizational characteristics, human aspects and external events. RCA can be used for investigating the causes of non-conformances in quality (and other) management systems as well as for failure analysis, for example in maintenance or equipment testing.

Course Information This highly interactive course will provide guidance on why and how to implement a quality system successfully into the research laboratory. By doing so, you will position your innovation for the success it deserves. But leave things as they are and there is a good chance that your science will not realise its full potential should success, and its consequences, come your way. A quality system in your research laboratory is the most effective and efficient way to: Help scientists work more efficiently Ensure discoveries can be defended Protect the value of intellectual property. This course is particularly aimed at those working in early phase research environments which are not constrained by the regulatory requirements of the Good Practice regulations but are producing intellectual property, testing and/or products for the therapeutic market. For organisational reasons, rather than regulatory ones, this is a place where you need to get it right. The programme is delivered by leaders in the field who, quite simply, ‘have done it’. Whether delegates are at senior management level seeking strategic direction, a laboratory head wishing to deliver science that will stand the test of time or a quality professional thrown in at the deep end, this course will provide key insight and practical guidance to underpin future success. Based on risk based systems, tried and tested over many years in the workplace, the programme will help delegates to define, train, implement and monitor the quality of their research, irrespective of field or discipline. Delegates will learn how to help position their organisation for success. Course content: Delegates will be guided thoughtfully through each key component of the process in a stimulating learning environment. The course probes all avenues of the research quality arena, from an initial understanding of the cultural aspects of the scientific discovery environment, to managing quality in outsourced research programmes. Computer systems and e-data security in the research environment will be discussed and pragmatic solutions described to help manage the ballooning cloud of e-data. In addition, the ever blurring boundary between the regulated and non-regulated research environments will be discussed and delegates given perspective on future developments in the field. With this knowledge, delegates will be able to get it ‘right first time’. Is this course for you? The course is designed for all those involved in the research laboratory quality arena and it has been tailored to meet the needs of scientific management, bench scientists and quality professionals alike. Delegates get immediate access to highly experienced tutors who will share their wisdom and insights in an area where few others have been successful. The course is linked with the RQA guidance which builds on years of experience and forms the foundation of the programme. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Sandrine Bongiovanni Associate Director in Research and Quality Compliance, Novartis Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:10 Welcome and Introductions 09:20 History and Overview of the Field Examples of business and regulatory risks and the consequences of low quality in research. A look at the standards and guidelines that exist. 10:00 The Culture, the Politics and the Scientist's Perspective Understanding research environments, the drivers and the challenges. 10:30 Break 10:45 Workshop - Risk Management Thinking about risk management and prioritisation. Looking at the critical factors for the implementations of a successful quality system. 12:15 Workshop - Feedback 12:45 Lunch 13:45 Personnel, Plans, Procedures, Facilities, Equipment, Materials and Reagents Looking at planning the work, defining procedures in a way which promotes robust science without compromising brilliance and ensuring that all these elements are demonstrably fit for their intended purpose. 14:30 Workshop - Assay Validation How much validation is required at what stage? What do we need to validate an assay? 15:00 Workshop - Feedback 15:15 Research, Work Records, Archives and Research Review Data and records which are accurate, attributable, legally attestable and safe to permit reconstruction experiments and studies. Looking at aspects of the work where there is a chance to review, correct or improve the science, the data and the processes. 16:15 Continual Improvement and Quality Systems Reviewing implementation of a quality system, finding opportunities for improvement, understanding culture change. 16:45 Questions and Answers 17:00 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 Develop

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Delegates with existing Agile project delivery experience can choose to take the Certification Assessment without enrolling on the course. Get your Continuing Professional Development recognised with a UK CPD Certification Service accredited C-ASDM certificate. Frequently Asked Questions I will receive my certificate as soon as I have completed the course You will initially receive an Assessment Completion report after completing the assessment. The report details the certification status: 'Pass' or 'Fail', and also includes information on which questions were answered incorrectly. The certificate is issued by the CPD Certification Service approximately four to six weeks after completing the certification assessment. A CPD certification is recognised by employers Yes! CPD certification is recognised by private and public sector employers, and in central government departments as a valuable way to evaluate the skills of an individual. Listing your CPD certification as well as the number of CPD Points you have achieved on your CV is essentially showcasing your achievements in continuing your professional development. One CPD Point is equivalent to an hour of training CPD points are units that quantify time, and the quality of learning and development activities. Delegates will earn 3 CPD Points upon successful completion of the CPD-ASE Certification Assessment, but will 13 CPD Points after completing the two-day course. My CPD certificate will expire after three years Your certificate will not expire however, best practice suggests a renewal after three years. You can do this by enroling in the C-ASDM course to ensure your knowledge of Agile as a Delivery Method is up to date. I will receive my certificate as soon as I have completed the course You will initially receive an Assessment Completion report after completing the assessment. The report details the certification status: 'Pass' or 'Fail', and also includes information on which questions were answered incorrectly. Your certificate is issued by the CPD Certification Service approximately four to six weeks after successfully completing and passing the C-ASDM Certification Assessment. A CPD certification is recognised by employers Yes! CPD certification is recognised by private and public sector employers, and in central government departments as a valuable way to evaluate the skills of an individual, and the quality of the learning activities. Listing your CPD certification as well as the number of CPD Points you have achieved on your CV is essentially showcasing your achievements in continuing your professional development. One CPD Point is equivalent to an hour of training CPD points are units that quantify time, and the quality of learning and development activities. Delegates will earn 3 CPD Points upon successful completion of the C-ASDM Certification Assessment, but will 13 CPD Points after completing the two-day course. My CPD certificate will expire after three years Your certificate will not expire however, best practice suggests a renewal after three years. You can do this by enrolling on the C-ASDM course to ensure your knowledge as Agile as a Delivery Method is up to date. Service Features Certification Agile Scrum as a Delivery Method - Essentials (C-ASDM) On-going support Email support No Telephone support No Webchat support No Online support No Community Support Delegates who achieve the pass mark for CPD certification are additionally offered access to our private 'Certified Scrum Practitioners’ Guild', a private Slack community of like-minded Agile professionals.

Join me over the next 10 weeks to unlock your full potential. Overcoming your day-to-day challenges without procrastination, without losing determination and making better decisions to improve your life! Program Details Module 1 (2 weeks) ✔ Wheel of life ✔ Your learning style ✔ Daily practice tools ✔ How to love and accept yourself Module 2 (3 weeks) ✔ Be self-aware of your inner critic ✔ Connecting with your true self ✔ Crush self-doubt ✔ Transform your inner critic  Module 3 (3 weeks) ✔ Create more energy in your life ✔ Create balance and purpose ✔ Maximise productivity ✔ Create your self care plan  Module 4 (2 weeks) ✔ Build the courage to step up ✔ Playing big ✔ Empowering affirmations ✔ Create your vision and implement it After completing the 10-week group programme, you will: • Be more resilient • Meet your challenges with confidence • Achieve your goals with clarity • Truly SHINE and be your authentic self My session with Pinky allowed me the time to ‘think out loud’ all the factors that were in play and my feelings towards them. She then worked out the barriers I was experiencing and seamlessly worked through them with me. She then gave me tools to continue to work past those barriers with some very achievable goals! I instantly felt like I had a better perspective on this change and felt less chaotic in my thoughts. Thanks, Pinky! - Gemma (Edinburgh)

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