- Professional Development
- Medicine & Nursing
- Arts & Crafts
- Health & Wellbeing
- Personal Development
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
Unlocking Our-Selves 2025: "Away With the Fairies"
By Therapy Harley Street
Personal development groups for practitioners with Bárbara Godoy A playground for therapists to expand our perception to metaphor, as a way to connect directly with the experience of the other, guided by folklore and fairytales. "Supportive, thought-provoking, emancipating, grounding" Tuesday Evenings Group 6 pm to 7.15 pm (UK Time) Friday Lunchtime Group 12.30 pm to 1.45 pm (UK time) Spring Term Phase One - 2025 22 and 29 April 6, 13, 20 and 27 May 3, 10, 17 and 24 June Autumn Term Phase Two - 2025 23 and 30 September 7, 14, 21 and 28 October 4, 11, 18 and 25 November Winter Term Phase Three - 2026 20 and 27 January 3, 10, 17 and 24 February 3, 10, 17 and 24 March Winter Term Phase One - 2025 24 and 31 January 7, 14, 21, 28 February 7, 14, 21 and 28 March Spring Term Phase Two - 2025 25 April 2, 9, 16, 23 and 30 May 6, 13, 20 and 27 June Autumn Term Phase Three - 2025 26 September 3, 10, 17, 24 and 31 October 7, 14, 21 and 28 November Venue: Online (Zoom) Fee: £350 per term or £900 the whole year Bárbara Godoy M.A., Adv. Dip. Exi. Psy. Existential Psychotherapist Group Leader, Counsellour, Lecturer and Supervisor, MBACP & UKCP accredited, SEA Professional Member, Director of Therapy Harley StreetBárbara’s academic contributions in London since 2008 include lecturing and researching on the theory and practice of Phenomenological Existential Therapy on Doctorate, MA and professional courses at the School of Psychotherapy and Counselling Psychology, Regent’s University and the New School of Psychotherapy and Counselling directed by Emmy van Deurzen. Bárbara has facilitated and designed therapeutic Group Work since 1997. She brought her earliest workshop: “Experiences” to large groups in The Netherlands, Italy, France, UK and Argentina. These awareness-intensive processes are a legacy of the human potential movement (HPM) of the 1960s, with techniques such as AUM Meditation Marathons, Psychodrama, Bioenergetics and Primal Feelings work. Organized by:
BEHAVIORAL INTERVIEWING: BUILDING A CONSISTENT FRAMEWORK AND PROCESS
(4)By Improving Communications Uk
LEARN ABOUT BEHAVIORAL VS. TRADITIONAL INTERVIEWING, AND HOW TO INCORPORATE AND DEVELOP INTERVIEWING SKILLS TO ENSURE THAT YOU FIND THE RIGHT CANDIDATE FOR THE JOB. Behavioral Interviewing means asking candidates questions that will help you to discover how the interviewee acted in specific employment-related situations. Because past performance is a good indicator of how someone will act in the future, this style of interviewing is extremely useful, and the method of choice for recruiting teams. In this session, you will learn about behavioral vs. traditional interviewing, and how you can incorporate and develop your interviewing skills to ensure that you have the right candidate for the job. OBJECTIVES Participants will be able to: Build a consistent framework and process to ensure an unbiased candidate experience; Choose job specifications and determine how success will be measured (skills); Identify characteristics and qualities that will support the required skills; Prepare questions to elicit descriptions of behaviors, attitudes, and skills necessary for the job; Review legal and appropriate interviewing etiquette/guidelines, including social media research; Screen candidates, using resumes and phone interviews; and Conduct successful role-play Behavioral Interviews in class. CLASSES WILL INCLUDE: Workbooks for future reference and study. Workshop / role play with actual interview scenarios to assist in internalizing data. Time for individual questions and concerns to aid in personalizing tactics. Online Format—Behavioral Interviewing is a 4-hour interactive online class for up to six people. Register for this class and you will be sent ONLINE login instructions prior to the class date. Rich has an engaging presentation style. The New Mexico chapter of the International Society for Performance Improvement (NMISPI) gave high marks to his interactive and lively Improving Customer Service workshop. There were opportunities to share ideas and analyze different techniques, and 87% of attendees said that they would recommend this workshop to others. Ildiko OraveczNew Mexico International Society for Performance Improvement
