56035 Courses

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

Official BRCGS Storage & Distribution Issue 4: Auditor course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

This is a gateway course for all further learning in FD&FA systems.

The Roasting Intermediate course builds upon the introductory concepts of the Foundation course. It is ideal for someone who has roasting and desires to gain a deeper understanding of the roast profile, how the profile relates to color, the relationship between roast profile and sensory expression, and the impact of development time. Learners will further explore the physical and chemical changes as well as basic thermodynamics and heat transfer that occurs during the roast. Thereafter there will be an introduction to sample roasting and a review of safety and maintenance protocols in the roasting plant. A written exam tests intermediate course knowledge while a practical exam assesses the learner’s ability to roast correctly and remove the coffee at the correct color using a reference, while accurately completing the roast log form.

Official BRCGS Packaging Sites Issue 6 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

QA Level 2 Award In Fire Safety (RQF) Face to Face Classroom: Full day course Online / Virtual Classroom: 3 sessions of 2½ hours Suitable for Fire Wardens/Fire Marshals and all other members of staff Provides a foundation of fire safety knowledge on which employers and ‘responsible persons’ can build, keeping the business safe from fire Benefits of this course: How much do you know about keeping yourself and others safe in the workplace? Fire Safety Law breaches can result in unlimited fines and imprisonment More importantly, how would you feel if someone got injured or even killed by a fire you could have prevented? This course is for anyone who has a specific responsibility for fire safety in the workplace, such as designated fire wardens/fire marshals Successful candidates will gain an understanding of fire safety management at work and the specific roles and responsibilities related to fire safety in the workplace. Course Contents: Causes of Fire in the Workplace The Fire Triangle Hazards during and after a Fire Fire and Smoke Spread Identifying and Controlling Fire Hazards Fire Safety Laws Duties and Responsibilities of Employers and Employees Undertaking a Fire Safety Inspection Fire Safety Risk Assessments Contents of a Fire Safety Briefing Roles and Responsibilities of the Nominated Fire Warden Accredited, Ofqual regulated qualification: Our Fire Safety course is a nationally recognised, Ofqual regulated qualification accredited by Qualsafe Awards.You can rest assured that the training your employees receive is of a high quality and the candidates will get a strong grounding in Fire Safety, helping to keep your staff and your business safe from fire.The Ofqual Register number for this course is 603/2756/X

Official BRCGS Packaging Auditor Conversion to Issue 7 course. Delivered online (Zoom) by a live BRCGS Approved Training Partner. Exam and Certificate fee included in the price.

Data Protection and Clinical Trials

Our exclusive Tranceworks course is the second part of of the 120-hour Advanced Hypnotherapy Diploma (HPD) course it is the perfect opportunity to elevate your practice with hands-on, face-to-face training.

Ten live dialogues between Prof Ernesto Spinelli and International Existential Therapists followed by an Experiential Study Group. A phenomenological approach to re-view psychopathology: We aim to explore the lived experiences of irregular perceptions of reality with an open mind. Each Saturday includes a live dialogue between Prof Ernesto Spinelli and an International Existential Therapist; a moment to share your thoughts and feelings with the teachers; and a final integration facilitated by Bárbara Godoy. This series of ten Dialogues set out to explore the multifaceted dimentions and complexities associated with Existential Therapies. It attempts to engage with various interpretations of insanity through the lens of patients' often painful, confounding, and deeply unsettling life experiences. TIMES AND DATES 2025 25 Jan. “Knots” with Prof. Ernesto Spinelli 2 Feb. “Healing” with Dr. Michael Guy Thompson 22 Mar. “Difference” with Dr. Todd DuBose 12 Apr. “Polarization” with Prof. Kirk Schneider 3 May “Character” with Prof. Robert Romanyshyn 21 Jun. “Opening” with Dr. Yaqui Martinez 19 Jul. “Meaning” with Dr. Jan Resnick 25 Oct. “Invention” with Dr. Betty Cannon 15 Nov. “Hallucination” with Prof. Simon du Plock 13 Dec. “Hysteria” with Bárbara Godoy Full course (including dialogues): £1260 (2 pm to 5 pm – UK time) Only Dialogues: £630 (2 pm to 3 pm – UK time) Venue: Online Zoom Read the full Programme here > Course Organised by: