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
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This course follows the Institute of Occupational Safety and Health's syllabus. A one-day programme, it is suitable for all people at all levels in the workplace and gives a basic introduction to the principles of environmental management. On successful completion of the course, participants will be able to: Understand the terms 'environment' and 'pollution' Understand the terms 'hazard' and 'risk' related to the environment Better appreciate environmental issues generally, and specifically in respect of their organisation Identify hazards to the environment from working practices Outline the procedures/controls necessary to prevent damage to the environment 1 What is the environment? - putting the environment in context Key environmental issues and how we contribute Definition of the environment 2 Working with the environment What is pollution? Sources, receptors and pathways Environmental consequences workshop - identifying the environmental consequences of our working practices Environmental risk assessment Effective control mechanisms 3 Protecting the environment - Environmental Management Systems What is an Environmental Management System (EMS)? What are the benefits of having an EMS? EMS structure and models Identifying what elements of EMS your company has and how they work Roles and responsibilities 4 Choice of module Option 1: Organisation-specific moduleThis module can be used to introduce environmental concepts that are specific to your activities and operations, and will be compiled through discussion with your organisation Option 2: Environmental best practiceIf no organisation-specific module is required, or if participants from a number of organisations attend, generic operational environmental best practices can be covered instead. Areas covered include waste management, fuel storage and use, hazardous materials, emissions to air and water and environmental incidents
A flexible, modular-based, programme to heighten participants' awareness of ways in which their operations can affect the environment, the principles of environmental management and the practical steps they need to take as individuals and as an organisation to improve environmental performance. Depending on the course modules selected, this programme will give participants: Increased awareness of relevant environmental issues A greater understanding of, and commitment to, the organisation's environmental management programme Preparation for any responsibilities they may have under an Environmental Management System Further benefits according to options chosen 1 Environmental awareness Definition of 'the environment' Key environmental issuesGlobal warmingOzone depletionAcid rainAir qualityWater pollutionContaminated landLand take and green belt shrinkageResource usageHabitat destruction and species extinctions. Option: This module can be used to explain the key environmental issues related to the activities of your own organisation. Diagrams, photos, pictures, examples and statistics relevant to your own organisation are used where possible to illustrate the points being made. 2 Environmental legislation Key elements of environmental legislation affecting the activities of your organisation - including international, European and UK legislation. Legislation of particular relevance to your organisation - how it affects the operations of your organisation Option: Legislation can be dealt with according to which aspect of the environment it protects (eg, air, water, waste) or which part of your organisation's activities it affects Consequences of breaching legislation 3 Environmental management systems Overview of what an environmental management system isHow is an Environmental Management System (EMS) designed and put together?Key elements (emphasising Plan - Do - Check - Review cycle)The need to continually improve Pros and consReasons for having an EMSBenefits of an EMSConsequences of not managing the environmentCosts of installing an EMS Explanation of ISO 14001 and EMAS standards and guidance as applicable to the EMSs of your organisationOverview of your organisation's EMSHow it was set up / is being developed / operatesWho is responsible for itKey parts of system (eg, environmental policy, objectives and targets) identified and discussedEMS documentation - what and where it is. Workshop option: Brainstorm 'Pros and cons' with the participants, come up with all their ideas for good and bad things about EMS and demonstrate that the 'good' list is longer than the 'bad' 4 Environmental consequences Define what an environmental impact is and discuss how they are determined, with reference to the EMS Identify why we want to determine the environmental consequences of operations and activities; how they are used in the EMS for planning, and reducing the impact on the environment Establish key environmental consequences of construction and operational activities on the site; discuss significance ranking and the control measures in place in your organisation. Workshop option: In small groups, participants are asked to identify the impact on the environment of your organisation's activities or a part of their activities. They are then asked to rank these impacts in terms of their significance, using guidelines provided to help them be aware of the contributing factors (eg, frequency, severity). For a selected number of the impacts, the participants are asked to identify what control measures there are and which of these they play a part in. All stages can be discussed with trainers as a whole group at various stages during the workshop. 5 Protected species, nature conservation and invasive weeds Nature conservation, landscape and visual issues in the planning process - overview of key nature UK wildlife legislation, EIA, appropriate timing of surveys, Hedgerow regulations and landscape and visual impact issues Ecological issues - ecological legislation, significant species, hedgerows Archaeology in the development process - why archaeology is important, organisation in the UK, legislation and planning guidance Construction phase issues and consents - major environmental issues during construction, including water resources and land drainage consents, discharges to land or water, water abstraction, public rights of way, tree protection, waste management, Special waste, noise, good practice pollution control and Environmental Audits Identification and management of invasive weeds - including legal position regarding management 6 Chemicals and fuels handling and storage How health and safety management is closely linked to environmental management of materials Planning - what mechanisms are in place for planning materials use; legislation, guidance and policies which define how to manage materials Materials storage - what are the considerations for storing materials, covering:Labels: what are the different types and what do they tell us?Storage facilities: what are the requirements for safe storage of materials (eg, signs, secondary containment, access, segregation, lids/covers)Handling: safe handling for protecting the environment, organisational procedures, high risk situations (eg, decanting, deliveries), how to reduce the risks (eg, use of funnels, proper supervision, training)COSHH and MSDS: brief explanation of legislation and its role in environmental control of hazardous materials, how to use the information provided by COSHH assessments Option: These sessions can be illustrated with photographs/pictures and examples of good and bad storage and handling practices Workshop Options: Labelling Quiz - quick-fire quiz on what different labels tell us; Build a Storage Facility - participants are asked to consider all the environmental requirements for building a safe storage facility for their organisation 7 On-site control measures Overview of the legislation associated with nuisance issues on site and mitigating problems when they arise Examples of bad practice, including fuel storage tanks and mobile equipment - costs involved with prosecution of fuel spills, remediation costs, management costs, legal fees, bad PR coverage Identification and management of contaminated land and relevant legislation Workshop option: Participants are provided with a site plan containing information on site features, environmental conditions and indications of potential issues 8 Waste management Why worry about waste? - a look at how waste disposal can impact on the environment, illustrated by examples of waste-related incidents, statistics on waste production on national, industry-wide and organisational levels, landfill site space, etc Legislation - overview of the relevant legislation, what the main requirements of the regulations are, what penalties there are, and the associated documentation (waste transfer notes) Waste classification - a more in-depth look at how waste is classified under legislation according to hazardous properties, referring to Environment Agency guidance Handling and storage requirements - what are the requirements of the applicable waste legislation and how are they covered by organisational procedures? Examples of good and bad environmental practice associated with handling and storing waste. Workshop option: 'Brown bag' exercise - participants pass round a bag containing tags each with a different waste printed on. They are asked to pick out a tag and identify the classification and the handling, storage and disposal requirements for the waste they select Waste minimisation - overview of the waste minimisation 'ladder' and its different options (elimination, reduction, reuse and recycling), benefits of waste minimisation, examples of waste minimisation techniques Workshop option: Participants are asked to identify opportunities that actually exist within the organisation for minimising production of waste that are not currently being taken advantage of 9 Auditing Requirements for environmental auditing of operations Auditing the EMS Types of internal and external audits Requirements EMS standards (ISO 14001 and EMAS) Carrying out internal audits and being prepared for external audits Workshop options:Mock audit 'Brown Bag' - can be used either for trainers to test participants as if they were in an audit situation, or for the participants to test each other and practice their auditing technique. The bag contains tags each with a different topic printed on (eg, waste skips); participants pass the bag round and select a tag; they are then questioned by the trainer or another participant about that topic as if they were in an audit situation. If the participants are auditing each other, they will be provided with a set of guidelines to keep in mind during the workshop.Virtual auditing - a more practical workshop where participants review photographs of situations/activities relevant to the organisation's operations. They are asked to identify all the good and bad environmental practices that are occurring in the situations. 10 Incident response What should you do when an incident does happen? What should be in a spill kit? When should you call in the experts? When should you inform the Environment Agency or Environmental Health Officer? Workshop option: The participants are provided with some incident scenarios and asked to develop a response to the incident 11 Monitoring and reporting Environmental monitoring programmes and procedures Monitoring and reporting as control measures for environmental consequences Monitoring and environmental 'STOP' card systems - personal and behavioural monitoring and reporting
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