Overview The course focuses on topics such as the fundamental concepts of auditing and quality management, principles of internal and external audit, auditing processes and tools, principles and practice of root cause analysis, communication and people skills, and other related topics. Students who successfully complete this course will gain the essential knowledge and skills necessary to become successful auditors and work with confidence to improve the processes in their organizations.
About this training course This 3-day training will provide a comprehensive understanding on the nature of costs and cost drivers in the E&P industry providing in-depth understanding on the budgeting process, proactive management, effective control and optimization of costs together with focused and relevant performance reporting. Training Objectives After the completion of this training course, participants will learn: Understand the nature of costs and cost drivers in the E&P industry through the Field Life Cycle Purpose of the Budget. Planning and Budgeting models. The Strategic and Medium-term plan Using budgets to make effective decisions. Prepare and understand costs in planning, budgeting & forecasting processes e.g. fixed / variable, capex / opex and routine / non-routine. Cost Accounting. Importance of timely cost capture and accurate recording e.g. VOWD / accruals, consistency of coding and clarity on accountability Strategic solutions in delivering cost optimization - 'do more for less' Management of costs in PSC and JV environments. Avoiding cost leakage and ensuring audit preparedness Cost Control Framework - budgets, AFEs, progress reports and variance analysis. Understanding key components and ensuring seamless interaction Cost Performance Reporting - use of KPI's, variance analysis and trend analysis. Tracking and monitoring cost optimization initiatives and targets Target Audience This training course is suitable and will greatly benefit the following specific groups: Finance staff with accounting and financial management responsibilities Those responsible for devising budgets, managing and controlling budgets Professionals engaged in planning, budgeting and management reporting Finance & Audit staff engaged on cost and financial controls Business unit managers and personnel whose responsibilities include cost management, controlling budgets and performance reporting Course Level Basic or Foundation Training Methods The training instructor relies on a highly interactive training method to enhance the learning process. This method ensures that all participants gain a complete understanding of all the topics covered. The training environment is highly stimulating, challenging, and effective because the participants will learn by case studies which will allow them to apply the material taught in their own organization. Course Duration: 3 days in total (21 hours). Training Schedule 0830 - Registration 0900 - Start of training 1030 - Morning Break 1045 - Training recommences 1230 - Lunch Break 1330 - Training recommences 1515 - Evening break 1530 - Training recommences 1700 - End of Training The maximum number of participants allowed for this training course is 25. This course is also available through our Virtual Instructor Led Training (VILT) format. Trainer Your expert course leader has more than 30 years of experience in the international oil and gas industry, covering all areas of Finance and Audit, including involvement in Commercial roles. During her 19 years with ENI she worked in Italy, Netherlands, Egypt and UK and was CFO for 2 major ENI subsidiaries. She has delivered training courses in Accounting, Audit, Economics and Commercial topics in many Countries. She has a Degree in Economics & Accounting and is a Certified Chartered Accountant. She is also a Chartered Auditor and an International Petroleum Negotiator. Outside of work, she is inspired by the beauty of nature and art, helping disadvantaged people, sports (football, golf) and her cat. Courses Delivered Internationally: E&P Accounting, Auditing in the Oil & Gas Industry Cost Control & Budgeting Introduction to the Oil & Gas Industry Petroleum Project Economics Contracts Strategy International O&G Exploitation Contracts POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations
Course Information Join our comprehensive three-day programme designed as an invaluable external training opportunity for auditors, audit programme managers, and individuals subject to audits. This course is tailored to foster a deep understanding and cultivate essential skills for auditing the validation of computer systems intended for GxP environments (GLP, GCP, GMP, GDP, GPvP). Commencing with an overview of regulatory prerequisites and the system life cycle, the course swiftly transitions to focus on the pragmatic aspects of auditing computer system validation. Experience a blend of presentations, interactive discussions, and immersive practical workshops throughout the duration of the course. Delegates will benefit from practical examples of how to understand the framework of applicable regulations and guidance. Apply risk management techniques to audit planning Plan and conduct computerised system audits Assess system validation documentation to verify compliance Evaluate data integrity and security issues Prepare for regulatory inspection. The course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Understand the vulnerabilities of computerised systems Learn how to create a compliance checklist Link system development with good business practice. Is this course for you? Auditors Audit programme managers Individuals subject to audits. 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 and Introductions 09:45 Why We Validate and Regulatory Trends 10:30 Break 10:45 Audit Overview, High Level Process and Scheduling 11:30 System Lifecycle 12:30 Lunch 13:15 Exercise 1 - Audit Scheduling 14:45 Exercise 1 - Feedback 15:15 Break 15:30 Validation Deliverables 16:30 Risk Assessments 17:30 Close of Day 1 Day 2 09:00 Supplier Assessment 10:30 Break 10:45 Exercise 2 - Planning a Supplier Audit 12:00 Exercise 2 - Feedback 12:30 Lunch 13:15 Exercise 3 - Auditing a Computerised System Validation Package 15:30 Break 15:45 Exercise 3 - Feedback 16:30 Change Control 17:15 Close of Day Day 3 09:00 Infrastructure Qualification 09:45 Maintaining a Validated State - Operational Processes 11:00 Break 11:15 Exercise 4 - Auditing Systems in Operational Use 12:45 Lunch 13:30 Exercise 4 - Feedback 14:15 Exercise 5 - Auditing Trail Review 15:30 Break 15:45 Exercise 5 - Feedback 16:15 Course Objectives Summary and Any Additional Questions 16:45 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
This qualification covers complex accounting and finance topics and tasks leading to students becoming confident with a wide range of financial management skills and applications. Course Overview This qualification covers complex accounting and finance topics and tasks leading to students becoming confident with a wide range of financial management skills and applications. Students will gain competencies in drafting financial statements for limited companies, recommending accounting systems strategies and constructing and presenting complex management accounting reports. Study the Level 4 Diploma in Professional Accounting to master complex accounting tasks and qualify for senior finance roles, as well as AAT full membership. The jobs it can lead to: • Accounts payable and expenses supervisor • Assistant financial accountant • Commercial analyst • Cost accountant • Fixed asset accountant • Indirect tax manager • Payroll manager • Payments and billing manager • Senior bookkeeper • Senior finance officer • Senior fund accountant • Senior insolvency administrator • Tax supervisor • VAT accountant Entry Requirements: Students can start with any qualification depending on existing skills and experience. For the best chance of success, we recommend that students begin their studies with a good standard of English and maths. Course Content: Applied Management Accounting (mandatory): This unit allows students to understand how the budgetary process is undertaken. Students will be able to construct budgets and then identify and report on both areas of success and on areas that should be of concern to key stakeholders. Students will also gain the skills required to critically evaluate organisational performance. Learning outcomes: • Understand and implement the organisational planning process. • Use internal processes to enhance operational control. • Use techniques to aid short-term and long-term decision making. • Analyse and report on business performance. Drafting and Interpreting Financial Statements (mandatory): This unit provides students with the skills and knowledge for drafting the financial statements of single limited companies and consolidated financial statements for groups of companies. It ensures that students will have a proficient level of knowledge and understanding of international accounting standards, which will then be applied when drafting the financial statements. Students will also have a sound appreciation of the regulatory and conceptual frameworks that underpin the preparation of limited company financial statements. Learning outcomes: • Understand the reporting frameworks that underpin financial reporting. • Draft statutory financial statements for limited companies. • Draft consolidated financial statements. • Interpret financial statements using ratio analysis. Internal Accounting Systems and Controls (mandatory): This unit teaches students to consider the role and responsibilities of the accounting function, including the needs of key stakeholders who use financial reports to make decisions. Students will review accounting systems to identify weaknesses and will make recommendations to mitigate identified weaknesses in future operations. Students will apply several analytical methods to evaluate the implications of any changes to operating procedures. Learning outcomes: • Understand the role and responsibilities of the accounting function within an organisation. • Evaluate internal control systems. • Evaluate an organisation’s accounting system and underpinning procedures. • Understand the impact of technology on accounting systems. • Recommend improvements to an organisation’s accounting systems. Business Tax (optional): This unit introduces students to UK taxation relevant to businesses. Students will understand how to compute business taxes for sole traders, partnerships and limited companies. They will also be able to identify tax planning opportunities while understanding the importance of maintaining ethical standards. Learning outcomes: • Prepare tax computations for sole traders and partnerships. • Prepare tax computations for limited companies. • Prepare tax computations for the sale of capital assets by limited companies. • Understand administrative requirements of the UK’s tax regime. • Understand the tax implications of business disposals. • Understand tax relief, tax planning opportunities and agent’s responsibilities in reporting taxation to HM Revenue & Customs. Personal Tax (optional): This unit provides students with the fundamental knowledge of the three most common taxes that affect taxpayers in the UK: Income Tax, Capital Gains Tax and Inheritance Tax. With this knowledge students will be equipped to not only prepare the computational aspects of taxes, where appropriate, but also appreciate how taxpayers can legally minimise their overall taxation liability. Learning outcomes: • Understand principles and rules that underpin taxation systems. • Calculate UK taxpayers’ total income. • Calculate Income Tax and National Insurance contributions (NICs) payable by UK taxpayers. • Calculate Capital Gains Tax payable by UK taxpayers. • Understand the principles of Inheritance Tax. Audit and Assurance (optional): This unit aims to give a wider understanding of the principles and concepts, including legal and professional rules of audit and assurance services. The unit will provide students with an awareness of the audit process from planning and risk assessment to the final completion and production of the audit report. Students will also get a practical perspective on audit and assurance, with an emphasis on the application of audit and assurance techniques to current systems. Learning outcomes: • Demonstrate an understanding of the audit and assurance framework. • Demonstrate the importance of professional ethics. • Evaluate the planning process for audit and assurance. • Review and report findings. Cash and Financial Management (optional): This unit focuses on the important of managing cash within organisations and covers the knowledge and skills to make informed decision on financing and investment in accordance with organisational policies and external regulations. Students will identify current and future cash transactions from a range of sources, learn how to eliminate non-cash items and use various techniques to prepare cash budgets. Learning outcomes: • Prepare forecasts for cash receipts and payments. • Prepare cash budgets and monitor cash flows. • Understand the importance of managing finance and liquidity. • Understand the way of raising finance and investing funds. • Understand regulations and organisational policies that influence decisions in managing cash and finance. Credit and Debt Management (optional): This unit provides an understanding and application of the principles of effective credit control systems, including appropriate debt management systems. Students will be introduced to techniques that can be used to assess credit risks in line with policies, relevant legislation and ethical principles. Learning outcomes: • Understand relevant legislation and contract law that impacts the credit control environment. • Understand how information is used to assess credit risk and grant credit in compliance with organisational policies and procedures. • Understand the organisation’s credit control processes for managing and collecting debts. • Understand different techniques available to collect debts. DURATION 420-440 Hours WHATS INCLUDED Course Material Case Study Experienced Lecturer Refreshments Certificate
CWSP training course description A hands-on training course concentrating solely on WiFi security with an emphasis on the delegates learning the necessary knowledge and skills to pass the CWSP exam. The course progresses from simple authentication, encryption and key management onto in depth coverage of 802.X and EAP along with many other security solutions such as access control, intrusion prevention and secure roaming. What will you learn Demonstrate the threats to WiFi networks. Secure WiFi networks. Configure: WPA2 RADIUS 802.1x EAP Pass the CWSP exam. CWSP training course details Who will benefit: Technical network staff. Technical security staff. Prerequisites: Certified Wireless Network Associate. Duration 5 days CWSP training course contents WLAN Security overview Standards, security basics, AAA, 802.11 security history. Hands on WLAN connectivity. Legacy 802.11 security Authentication: Open system, shared key. WEP. VPNs. MAC filters. SSID segmentation, SSID cloaking. Hands on Analysing 802.11 frame exchanges, viewing hidden SSIDs. Encryption Basics, AES, TKIP, CCMP, WPA, WPA2. Hands on Decrypting 802.11 data frames. 802.11 layer 2 authentication 802.1X: Supplicant, Authenticator, Authentication server. Credentials. Legacy authentication. EAP, Weak EAP protocols, Strong EAP protocols: EAP -PEAP, EAP-TTLS, EAP-TLS, EAP-FAST. Hands on Analysing 802.1X/EAP frames. 802.11 layer 2 dynamic key generation Robust Security Network. Hands on Authentication and key management. SOHO 802.11 security WPA/WPA2 personal, Preshared Keys, WiFi Protected Setup (WPS). Hands on PSK mapping. WLAN security infrastructure DS, Autonomous APs, WLAN controllers, split MAC, mesh, bridging, location based access control. Resilience. Wireless network management system. RADIUS/LDAP servers, PKI, RBAC. Hands on 802.1X/EAP configuration. RADIUS configuration. 802.11 Fast secure roaming History, RSNA, OKC, Fast BSS transition, 802.11k. Hands on Roaming. Wireless security risks Rogue devices, rogue prevention. Eavesdropping, DOS attacks. Public access and hotspots. Hands on Backtrack. WiFi security auditing Layer 1 audit, layer 2 audit, pen testing. WLAN security auditing tools. WiFi security monitoring Wireless Intrusion Detection and Prevention Systems. Device classification, WIDS/WIPS analysis. Monitoring. 802.11w. Hands on Laptop spectrum analysers. VPNs, remote access, guest access Role of VPNs in 802.11, remote access, hotspots, captive portal. Wireless security policies General policy, functional policy, recommendations.
Oracle Database 12c Admin training course description This Oracle Database 12c Administration course is designed to give the Oracle database administrator practical experience in administering, monitoring, tuning and troubleshooting an Oracle 12c database. Database administrators will gain an understanding of the architecture and processes of the Oracle database server. They will be able to ensure the integrity and availability of a company's data within the Oracle environment. They will be able to monitor the performance of the database, allocate resources with the Resource Manager and Schedule jobs. What will you learn Administer an Oracle database instance. Monitor an Oracle database. Configure the Oracle network environment. Create and manage database storage structures. Manage users, profiles, privileges and roles. Manage undo data and temporary segments. Monitor and resolve lock conflicts. Maintain database security. Implement database auditing. Monitor the performance of the Database. Load and unload data. Use the job scheduler. Configure a database for backup and recovery. Oracle Database 12c Admin training course details Who will benefit: This Oracle Database 12c Administration course is for anyone who needs to administer, monitor and support an Oracle 12c database. Prerequisites: An understanding of relational database concepts and good operating system knowledge. They should have attended the Oracle SQL course or have a good working knowledge of Oracle SQL. Knowledge of the usage of PL/SQL packages is highly recommended. Duration 5 days Oracle Database 12c Admin training course contents Introduction to Oracle database 12c Overview of the Oracle database 12c, Overview of the Oracle Cloud, Relational database concepts, database administration tasks. Oracle Database 12c Architecture Overview of the Oracle database architecture, The Oracle database instance, Oracle Database memory structures, Process architecture and structures, Server and client processes, The Oracle database storage architecture, Connect to the Oracle database instance. Administer a database instance Administrative tools available to a DBA, Use SQL*Plus in Oracle to manage a database instance, Use SQL Developer to manage a database instance, Administer the database using Enterprise Manager (EM), Overview of the Enterprise Manager framework, Access Enterprise Manager Database Express, The Enterprise Manager Database Express Home Page, Enterprise Manager Cloud Control, Initialization parameter files. Configure the Oracle network environment Overview of network configuration, Oracle Net Listener configuration and management, Oracle Net naming methods, Tools for configuring and managing the Oracle network, Using the Net Configuration Assistant, Configure client connections with Net Manager, View listener configuration, Start and stop the Oracle listener, Use TNSPING to test Oracle Net connectivity, Connect to the database, Configure Net Services with Enterprise Manager. Storage Structures Overview of data storage, The database block, Overview of tablespaces and datafiles, Use Enterprise Manager to view the storage structure of the database, Create and alter tablespace commands, Temporary tablespaces, Create and manage datafiles, Use OMF, Drop tablespaces and datafiles. Manage users Predefined database administration accounts, User accounts, Create a user account, User authentication, Change a user's password, Manage a user account, Drop a user account, Monitor user information, Terminate user sessions. Manage profiles and resources Overview of user profiles, Profile resource parameters, Create profile command, Manage passwords with profiles, Control resource usage with profiles, Maintain profiles. Manage privileges Database access, Oracle supplied roles, System and object level privileges, The grant and revoke commands, Create, modify and drop roles, Use predefined roles. Database auditing Overview of database security, Overview of database auditing, Security compliance, Standard auditing, Unified audit trail, Separation of audit responsibilities with the AUDIT_ADMIN and AUDIT_VIEWER roles, Configure the audit trail, Specify audit options. Data concurrency and lock conflicts Levels of locking in Oracle, Methods used to acquire locks, Data concurrency, Possible causes of contention, DML locks, Prevent locking problems, Detect lock contention, Resolve conflicts. Undo management Undo data overview, Monitor and administer undo, Configure undo retention, Switch undo tablespaces, Specify the retention period, Guarantee undo retention, Retention period for flashback queries, View undo space information, Use the undo advisor, Size the undo tablespace, Alter an undo tablespace to a fixed size. Proactive database management Database Maintenance, View the alert log, The Automatic Workload Repository, Statistic levels, The Automatic Database Diagnostic Monitoring, Monitor an Oracle database, Use the Advisors, Set up notification rules/ Performance management Tuning information sources, Performance monitoring, Tuning activities, Performance planning, Instance tuning, Performance tuning methodology, Performance tuning data, Monitoring performance, Managing memory. SQL tuning SQL tuning, The Oracle Optimizer, SQL Plan directives, Adaptive execution plans, SQL Advisors, Automatic SQL Tuning results, Implement automatic tuning recommendations , SQL Tuning Advisor. Moving data Create directory objects , Data Pump architecture, Data Pump data dictionary views, Data Pump interactive mode, Data Pump API, Use Data Pump to export and import data, Overview of SQL Loader, Command line parameters, Record filtering, Control file keywords, Datafiles, SQL Loader data paths, External Tables. Automate tasks with the scheduler Introduction to the Scheduler, Access Rights, Scheduler components and workflow, Create a Job, Job Classes, Use time based, event based schedules, Create an event based schedule. Managing resources with Resource Manager Overview of the Database Resource Manage, Use the Resource Manager, Create Resource Plans, The default maintenance resource manager plan, Create Resource Plan Directives, Allocate resources for Resource Plans. Manage space Overview of space management, Block space management within segments, Segment types, Allocate extents, Allocate space, Row chaining and migration, Create tables without segments. Backup and recovery configuration Oracle backup solutions, Oracle suggested backup strategy, Overview of database backup, restore and recover, Flashback technology, Types of failure ,Instance recovery, Tune instance recovery, The MTTR Advisor, Media failure, Configure a database for recoverability Oracle support The Enterprise Manager Support Workbench, Register for security updates, Work with Oracle Support, My Oracle Support integration, Log Service Requests, Manage patches, Apply a patch
About this training course This 3-day introductory-level course provides a comprehensive overview of international accounting and finance practices in the E&P industry. It is particularly suitable for finance personnel who are new to the oil and gas industry, or want to gain a broader understanding of oil and gas financial policy, joint venture and cost-control topic areas. Training Objectives After the completion of this training course, participants will be able to: Comprehend an overview of accounting policies and practices in the oil and gas industry Manage project development and operating costs Understand the accounting and financial management implications of exploring for and producing oil and gas Review the background to financial issues like joint ventures that are unique to the E&P industry, and their accounting treatment Target Audience This training course is suitable and will greatly benefit the following specific groups: Finance staff new to the industry who require a grounding in the various specialist discipline areas that typically comprise an oil and gas company finance function Finance personnel who are being developed for broader accounting and financial management responsibilities Audit and information systems staff who have frequent dealings with financial controls and systems Treasury and tax specialists who require a better understanding of E&P finance and accounting Course Level Basic or Foundation Training Methods The training instructor relies on a highly interactive training method to enhance the learning process. This method ensures that all participants gain a complete understanding of all the topics covered. The training environment is highly stimulating, challenging, and effective because the participants will learn by case studies which will allow them to apply the material taught in their own organization. Course Duration: 3 days in total (21 hours). Training Schedule 0830 - Registration 0900 - Start of training 1030 - Morning Break 1045 - Training recommences 1230 - Lunch Break 1330 - Training recommences 1515 - Evening break 1530 - Training recommences 1700 - End of Training The maximum number of participants allowed for this training course is 25. This course is also available through our Virtual Instructor Led Training (VILT) format. Trainer Your expert course leader has more than 30 years of experience in the international oil and gas industry, covering all areas of Finance and Audit, including involvement in Commercial roles. During her 19 years with ENI she worked in Italy, Netherlands, Egypt and UK and was CFO for 2 major ENI subsidiaries. She has delivered training courses in Accounting, Audit, Economics and Commercial topics in many Countries. She has a Degree in Economics & Accounting and is a Certified Chartered Accountant. She is also a Chartered Auditor and an International Petroleum Negotiator. Outside of work, she is inspired by the beauty of nature and art, helping disadvantaged people, sports (football, golf) and her cat. Courses Delivered Internationally: E&P Accounting, Auditing in the Oil & Gas Industry Cost Control & Budgeting Introduction to the Oil & Gas Industry Petroleum Project Economics Contracts Strategy International O&G Exploitation Contracts POST TRAINING COACHING SUPPORT (OPTIONAL) To further optimise your learning experience from our courses, we also offer individualized 'One to One' coaching support for 2 hours post training. We can help improve your competence in your chosen area of interest, based on your learning needs and available hours. This is a great opportunity to improve your capability and confidence in a particular area of expertise. It will be delivered over a secure video conference call by one of our senior trainers. They will work with you to create a tailor-made coaching program that will help you achieve your goals faster. Request for further information post training support and fees applicable Accreditions And Affliations
Overview Objectives Define brands and understand the opportunities and challenges facing them in highly competitive business landscapes Plan and craft a powerful brand positioning statement that reflects the brand's promise and the expectations of their most valued customers Build a strategic brand and track its growth and sustainability using researched processes Explore the elements of brand equity and the constituents of brand identity to build consistent and sustainable brands Identify various brand strategies to come up with sound actions aligned with the status of existing and new markets and products Master the process for conducting a full brand audit to evaluate brand performance and take remedial actions
Boost your expertise in this EnergyEdge's cost control and budgeting for exploration and production course. Enroll now and enhance your career!
Course Information A must-have programme for Quality Assurance auditors stepping into or honing their role within a Good Laboratory Practice (GLP) environment, this course offers invaluable, expert guidance for crafting a robust and efficient GLP audit programme. What will I learn? A solid regulatory foundation underpinning quality assurance activities Clarity on the roles of Quality Assurance, management, and study director within the framework of Good Laboratory Practice principles Enhanced efficacy in inspections and audits Heightened compliance with Good Laboratory Practice standards for your facility Unique insights into governmental monitoring activities within the GLP sphere. This course is structured to encourage delegates to Discuss and develop ideas Solve specific problems Examine particular aspects of GLP. Tutors Tutors will be comprised of (click the photos for biographies): Cate Ovington Director, The Knowlogy Group Ltd Jane Elliston Senior Quality Assurance Auditor, Battelle UK Shona Ross Head of QA, Tower Mains Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:15 Good Laboratory Practice Standards and Regulations An insight into the background and history of Good Laboratory Practice. 09:45 Principles of Quality Assurance What is the role and responsibilities of QA in GLP. Maintaining the independence of QA and what is an audit. 10:30 Break 10:45 Standard Operating Procedures GLP requirements and QA involvement. 11:30 Study Plans GLP requirements and QA involvement. 12:05 QA Programme Risk based programme, what are study, process and facility audits. 13:00 Lunch 14:00 Inspections Attitudes, techniques and attributes. 14:40 Workshop 1 - Facility and Process Inspections An exercise in inspection planning and preparation for inspections. 15:15 Break 15:30 Workshop 1 - Feedback 15:45 The Auditor and Audit Conduct Attitudes, attributes and techniques. 16:30 Panel Session An opportunity for delegates to put questions to the panel of speakers. 17:15 Close of Day Day 2 09:00 Workshop 2 - A Mock Audit 10:45 Break 11:00 Workshop 2 - Feedback 11:30 Auditing the Study Report Techniques and methods for the QA audit of the study report. 12:00 Record Keeping and Data The impact of GLP on data and records management. 12:40 Lunch 13:25 Data Integrity A look at the OECD GLP guidance document; the expectations of the regulators and the involvement of QA - Where QA adds value. 14:15 Workshop 3 - Amendments to Study Plan and Deviations from the Plan What are they? What is the difference between them? How are they controlled? 15:00 Workshop 3 - Feedback 15:15 Break 15:30 Regulatory Compliance GLP Monitoring Authority monitoring for compliance with Good Laboratory Practice. 16:15 Panel Session An opportunity for delegates to put questions to the panel of speakers. 16:45 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 14 Points Development Level Learn