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59275 Courses
Introduction to Computer Systems Validation
By Research Quality Association
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
MA Filmmaking
By London Film School
An intensive two-year course with a School located in the heart of London, the MA Filmmaking trains to a professional level in a full range of filmmaking skills. Students leave with a portfolio of directing, cinematography, editing, producing, production design and sound credits. The school produces a huge output of films each year on this particular programme, many of which are screened at key festivals annually, previously winning many prizes, including at Locarno, Berlinale, Edinburgh, LaCinef (Cinéfondation). Learning is based on short film production and our students make a new film each term. Each term these film exercises become more technically sophisticated, more considered and more complex in their ambitions. The school specifies the skill base for each exercise, providing the equipment and training students to new levels in each of the various craft skills. Students make all aesthetic decisions while solving problems similar to those faced by professional units, on a steeply increasing slope of difficulty. The work is constantly assessed and critiqued. This is the core of the London Film School method. Students learn by applying themselves to aesthetic and practical problems generated by the actual process of filmmaking.
The qualification aims to equip the learner with the skills, knowledge and understanding required to plan and instruct programmes for exercise referral. Learners will cover: Skills relating to the qualification: Collect and analyse nutritional information and apply the principles of nutrition to a physical activity programme. Collect information about exercise referral patients and prepare patients and resources for exercise referral sessions. Instruct, adapt, conclude and review exercise referral sessions. Agree on goals, plan, manage, review progress and adapt an exercise referral programme with exercise referral patients.
KNOW THE RULES! POOR GRAMMAR SHOWS A LACK OF ATTENTION TO DETAIL AND ULTIMATELY CAN SLOW DOWN COMMUNICATIONS AS WELL AS PRODUCTIVITY. Business people who know grammar judge others based on their correct (or incorrect) usage. Be the professional who is able to be clear and correct in writing. Business Grammar & Usage: ENGLISH BOOT CAMP is the answer for today’s business competitive environment. Interactive instruction and collaboration with your fellow attendees means that you will master the skills and apply your new knowledge to the classroom exercises and activities. When you return to work, you’ll have new confidence about what is right and wrong, when it comes to writing. Attendees Will Be Able To: Know the Parts of Speech and their correct uses; Understand Sentence Structure, including applying rules for Subject-Verb and Pronoun-Antecedent Agreement; Be able to create Plurals and Possessives accurately and with certainty; Review and use the rules of Spelling, Mechanics (Capitalization, Abbreviation, Number Use), and Punctuation; Create original email / documents to employ newly-learned class material. Online Format—Business Grammar and Usage is a 4-hour interactive virtual class for up to ten people. Register for this class and you will be sent ONLINE login instructions prior to the class date. It was great to have the opportunity to learn some new techniques and to gain more awareness of how I present myself. The most immediately applicable uses have been in reducing my “ums” and “ahs” and in trying to come to my point in a more succinct way. I’ve been cultivating this awareness in one-on-one settings; meetings and individual conversations. Christina Vargas
