5 Courses in Liverpool delivered Live Online

Course Information This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks. Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings. Is this course for you? Ideal for professionals engaged in GMP across various sectors, including: Research and Development (R&D) Contract Manufacturing Organisations Manufacturing Units Quality Control (QC) Laboratories Auditing Roles. What will you learn? Event objectives - by the end of the course, delegates shall: Have an awareness of the basic requirements of GMP Be aware of UK and EU GMP Rules and Guidance and relevant publications Understand the roles and responsibilities associated with GMP Be able to contribute to and maintain quality documentation Have a basic understanding of product lifecycle and manufacturing Understand the requirements of GMP in the QC laboratory context Have a basic understanding of risk management and mitigation principles Understand the need for quality systems and quality assurance activities Be aware of common regulatory findings. Learning outcomes: delegates will be able to: Implement their role within GMP with confidence and knowledge of the principle requirements Contribute effectively to the GMP quality system and their organisation’s compliance Comprehend where their organisation’s activities sit within the larger GMP arena Know where to seek further information within the published rules and guidance, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 09:30 Introductions and Scope of the Course Understand the group requirements and the tutor's background and experience. 09:45 Background and Regulatory Environment Setting the scene, understanding the context, key legislation. 10:30 Principles of GMP Key points and requirements. 11:15 Break 11:30 Personnel and Responsibilities Management and staff, duties and accountabilities. 12:00 Overview of GMP Manufacturing Basics of the product life cycle. 12:30 Lunch 13:15 Risk Management Workshop Practical exploration of risk and mitigation activities. 14:30 QC Laboratories Activities and practicalities. 15:15 Break 15:30 Compliance Quality Assurance and Self Inspection. 16:15 Question Time A chance for questions on the practicalities of GMP. 16:30 Close of Course Extra Information 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 7 Points   Development Level Learn

Essential OTN training course description An In-depth introduction to the terminology and technology that will comprise tomorrow's Optical Transport Networks. What will you learn Describe the problems with old technologies. Identify the purpose of new technologies. Describe the functionality of the various transmission mediums available Identify OTN features and functionality. Define the issues involved in equipment and application rollout. Essential OTN training course details Who will benefit: Anyone wishing to learn OTN. Prerequisites: SDH foundation or Essential DWDM Duration 2 days Essential OTN training course contents Scope, References Terms and definitions, Abbreviations and Conventions Optical transport network interface structure Multiplexing/mapping principles and bit rates Optical transport module (OTM-n.m, OTM-nr.m, OTM-0.m and OTN 0.mvn) Physical specification of the ONNI Optical channel (OCh) Optical channel transport unit (OTU) Optical channel data unit (ODU) Optical channel payload unit (OPU) OTM overhead signal (OOS) Overhead description and maintenance signals Mapping of client signals and concatenation Mapping ODUk signals into the ODTUjk signal Forward error correction using 16-byte interleaved RS (255,239) codecs ODUk tandem connection monitoring (TCM) overhead OPUk Multiplex Overhead Amendment 2 including: OTN Multiplexing and Mapping, Basic signal structure, ODTU12, ODTU13, ODTU23, OPUk Multiplex Overhead, OPUk Multiplex Structure Identifier (MSI). OPU2 Multiplex Structure Identifier (MSI), OPU3 Multiplex Structure Identifier (MSI), OPUk Payload Structure Identifier Reserved overhead (RES), ODU1 into ODU2 multiplexing, ODU2 into ODU3 multiplexing, ODU1 into ODU3 multiplexing Amendment 3 including: 40 Gbit/s ODU3/OTU3 and 100 Gbit/s ODU4/OTU4, Support of gigabit Ethernet services via ODU0, ODU2e, ODU3 and ODU4, ODU0 and ODUFlex, Multi-lane OTU3 and OTU4 interfaces, Support for InfiniBand Amendment 4 including: OTSn OTN synchronization messaging channel (OSMC) overhead, FC-1600 Amendment 5 Including: ODUk.ts, OTU0LL (OTU0 low latency), OTSiA (optical tributary signal assembly). OTSiG (optical tributary signal group), OTSiG-O (optical tributary signal overhead), CMEP (connection monitoring end- point), CMOH (connection monitoring overhead), MOTU (Multi-OUT), MOTUm (Multi-OTU with management), OTUCn-M (Optical Transport Unit-Cn, with n OxUC overhead instances and 5G tributary slots). SOTU (Single-OUT). SOTUm (Single-OTU with management). Modified bit rates and capacity for OTU1/2/3/4 OTM.nr.m, OTM.n.m, OTM.0.3v4, OTM 0.4v4 Mapping of CBR2G5, CBR10G, CBR10G3 and CBR40G signals into OPUk 64B/66B and 513B block code format PCS lane alignment marker for 40GBASE-R and 100GBASE-R PT=20/PT=21 and AMP/GMP options OTL 4.10 to OTL 4.4 gearbox ODU switching and Line protection Schemes 10 x 10 MSA Overview of current and future coherent and noncoherent technologies 40Gbit and 100Gbit compliant ROADM's Implementers Guide including replacement terms. Differing vendor's equipment and their implementations Individual and group planning exercises: Upgrade a customer STM-64/10G network to a 40G/ OTN network. Upgrade a customer old 16 Wavelength WDM network to be OTN compliant. Implement a new customer 40 wavelength OTU3 OTN compliant MSPP (DWDM) network. Design a cost-effective solution where we can hand over circuits using 'Optical Transport Lanes'.

This course is designed to equip participants with comprehensive knowledge in Pharmaceutical Quality System and Good Manufacturing and Distribution Practices. It covers the entire lifecycle of pharmaceutical production, from initial design and development to distribution and compliance. The course includes real-world case studies and interactive tools. Course Objectives Career Launch: Equip those with little or no GMP/QA experience with the essential knowledge, practical skills, and industry support needed to launch a successful career. Comprehensive Foundation: Provide a strong foundational understanding of QA in the EU, UK, and US, preparing you for diverse opportunities in the global market

Course Information This one day course is designed to provide you with comprehensive guidance and practical help for when designing and implementing audit programmes. Using the guidance of ISO 19011 with reference to PV, GCP, GMP and GLP audit programmes, you will explore audit programme design, operation, review and improvement. The course will work through why audits are important and understanding the drivers behind a good audit programme. It will discuss how to identify and assess the risks in your organisation, linking them with organisational goals, using these risks as a basis for the design of a risk-based audit programme during facilitated practical workshops. Delegates will have the opportunity to consider and discuss common issues and constraints that may shape their audit programmes. By the end of the course you will have: A clear understanding of the role of audit programmes in managing compliance and of the drivers and risks behind audit programmes An understanding of the roles and responsibilities of management and personnel An appreciation of resourcing implications and auditor attributes A good insight into the practicalities and activities required for design of risk based audit programmes A comparison of your circumstances, challenges, common issues and ways to approach managing audit programmes with other delegates on the course. Tutors Tutors will be comprised of (click the photos for biographies): Louise Handy Director, Handy Consulting Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:15 Why do we Need to Audit? Exploring risk and regulation, responsibility and performance. 09:45 Discussion - Programmes, Needs, Commonalities Understanding the needs of delegates' own organisation and comparing common themes and threats. 10:00 Establishing an Audit Programme Design, objectives, risk and resources. This session discusses the consideration when designing audit programmes. 10:30 Break 10:45 Risk Management Considerations, guidance and methods for assessing and controlling risk. 11:00 Workshop 1 - Risks, Prioritisation and Control Looking at specific risks, assessing and evaluating to feed into audit programme management. 12:00 Workshop 1 - Feedback 12:30 Lunch 13:30 Putting it into Practice Resources, practicalities and challenges - the realities of auditing, including selection of auditors, ensuring practice will meet expectations and the reasons to note audit results. 13:45 Workshop 2- Designing Audit Programmes Designing audit programmes using output from risk assessment process. Challenges and flexibility. 15:00 Break 15:15 Workshop 2 - Feedback 15:30 Monitoring, Reviewing and Improving Why or when should existing processes change, understanding the implications of change or inaction and exploring how to improve the audit programme. 16:15 Panel Session This final session will address any outstanding issues raised by delegates. 16:30 Close of Course Extra Information 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 7 Points   Development Level Develop

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