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
This course leads to the Mediterm Advanced Certificate in Medical Terminology (Level 3), the highest qualification in Medical Terminology, and can be studied flexibly over 20 weeks
Gain the most from work, education and everyday life, and achieve your equivalent to GCSE grade C or 4 held every Thursday afternoon – 4pm till 6pm for 12 weeks with our dedicated tutor. These sessions will be via live Team’s webinar classes, covering 3 areas: Speaking, Listening and Communication, Reading and Writing. Through the completion of this qualification, you will demonstrate that you have Presentation, Q&A and Group discussion skills as well as Reading and Writing skills, to our tutor. The qualification is awarded by Highfield OFQUAL-regulated and nationally recognised. Learn more about the Functional Skills Qualification in English at Level 2 Giving you Presentation, Q&A and Group discussion skills as well Reading and Writing with practice exams our tutor will support you all the way to help you achieve that examination to move your career in the right direction. As part of one of our apprenticeship courses – This course could be government funded – so ask for more information. Course Dates Every Thursday 4pm - 6pm 12 week rolling course Costs £400.00 per person (inc. VAT) Any additional resits of exams are charged at £30 each.
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Portfolio, Programme, and Project Offices (P3O®) Practitioner: In-House Training P3O® is the AXELOS standard for the design of decision-making processes regarding changes in organizations. P3O provides a guideline for the design of portfolio, programme, and project offices in organizations. The P3O Practitioner Course is an interactive learning experience. The P3O Practitioner-level content provides you with sufficient knowledge and understanding of the P3O guidance to design, implement, manage or work within any component office of a P3O model. It enables participants to successfully complete the associated P30 Practitioner exam and achieve the qualification. In this course, you will be prepared to successfully attempt the P3O Practitioner exam and learn how to implement or re-energize a P3O model in their own organization. What you will Learn At the end of the P3O Practitioner course, you will be able to: Define a business case to get senior management approval for P3O Build a right P3O model to adapt to the organization's needs, taking account of the organization's size and portfolio, programme and project management maturity Identify the elements, roles, and functions deployed in a generalized P3O model Use tools and techniques in running the P3O and advising those who shape the portfolio of programmes and projects Introduction to P3O What is the purpose of P3O? Definitions What are P3Os? Portfolio, programme, and project lifecycles Governance and the P3O Designing a P3O Model Factors that affect the design Design considerations What functions and services should the P3O offer? Roles and responsibilities Sizing and tailoring of the P3O model Why have a P3O? How a P3O adds value Maximizing that value Getting investment for the P3O Overcoming common barriers Timescales Why have a P3O (Extension)? The P3O Business Case The P3O Model Blueprint Vision Statement Demonstrating the Value KPIs The Benefits of Claimed Capabilities Benefit Realisation and Strategic Objectives Benefit Profile How to Implement or Re-Energize a P3O Implementation lifecycle for a permanent P3O Identify Define Deliver Close Implementation lifecycle for a temporary programme or project office Organizational context Definition and implementation Running Closing Recycling How to operate a P3O Overview of tools and techniques Benefits of using standard tools and techniques Critical success factors P3O tools P3O techniques
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