Course Information Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. Is this course for you? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. This course will give you: Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) Insight into the seamless integration of GCLP within clinical programmes (GCP) Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) Access to a seasoned panel of speakers with extensive expertise A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. Engage in: Lively discussions to foster ideas Problem-solving sessions targeting specific challenges Detailed exploration of specific aspects within the realms of GCP and GCLP. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Louise Handy Director, Handy Consulting Ltd Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introduction 09:20 Good Clinical Practice and the Requirements of Good Clinical Laboratory Practice A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 Safety and Ethical Consideration Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 Break 10:55 Organisation and Personnel Responsibilities within GCP and the Laboratory The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 Staff Training and Training Records Personnel records of training and competency assessments are discussed. 11:45 Laboratory Facilities, Equipment and Materials Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 Lunch 13:15 Workshop 1 - Facilities, Equipment and Responsibilities Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 Workshop 1 - Feedback 14:15 Computer Systems Validation Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 Trial Protocols, Analytical Plans During this session we examine the purpose, content, control and change of these important documents. 15:30 Break 15:45 Workshop 2 - SOPs, Clinical Protocols, Analytical Plans and Validation The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 Workshop 2 - Feedback 17:00 Close of Day Day 2 09:00 Conduct of the Work and Quality Control Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 Deviation Management The expectations around deviations and CAPA are discussed. 10:15 Workshop 3 - Conduct of the Work and Quality Control Practical work conduct and quality control issues are explored. 10:45 Break 11:00 Workshop 3 - Feedback 11:30 Source Data, Data Integrity, Records and Reports The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 Workshop 4 - Data, Records and Reports Practical problems with data, records and reports are investigated. 12:45 Lunch 13:30 Workshop 4 - Feedback 14:00 Quality Audit The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 Risk Management How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 Break 15:30 Regulatory Inspection The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 Panel Session This panel session will address any outstanding issues raised by the delegates. 16:15 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 Develop
PRINCE2® Foundation: In-House Training Projects fail for a variety of reasons including poor planning, lack of defined quality criteria, poor understanding of the business drivers, inadequate control, and lack of senior management involvement in other words, lack of a structured best practice approach to project delivery. PRINCE2® (6th Edition is the current version) is a structured, process-based approach to project management providing a methodology which can be easily tailored and scaled to suit all types of projects. It is the de facto standard for project management in the UK Government and is used extensively in more than 150 countries worldwide with in excess of 20,000 organizations already benefiting from its powerful approach. It can be used easily in combination with PMI®'s PMBOK® Guideto provide a robust project management methodology, or to augment an existing PMBOK®-based methodology with additional rigor around areas such as Quality, Organization, and Benefits Realization. The goals of this course are to provide participants with a thorough grounding in PRINCE2® and its benefits and to prepare them to sit the Foundation exam. What you will Learn You'll learn how to: Identify the benefits and principles underlying a structured approach to project management Define the PRINCE2® method in depth, including the principles, themes, and processes Prepare and practice for the Foundation exam Getting Started Introductions Course structure Course goals and objectives Overview of the PRINCE2® Foundation exam PRINCE2® Introduction Introducing PRINCE2® The structure of PRINCE2® What PRINCE2® does not provide What makes a project a 'PRINCE2® project'? Project Management with PRINCE2® Defining a project Managing a project Controlling the variables The Project Manager's work PRINCE2 Principles PRINCE2® Principles The Seven Principles Tailoring and Adopting PRINCE2® Defining tailoring Defining embedding What can be tailored? Who is responsible for tailoring? Introduction to the PRINCE2® Themes What is a PRINCE2® Theme? What are the PRINCE2® Themes? Tailoring the themes Format of the theme chapters Business Case Need for a business case Elements of a business case How a business case is developed Managing Benefits Organization Need for a special type of organization PRINCE2® organization structure Roles in a PRINCE2® project Combining roles Quality Relevance of quality to project work Quality, quality control, and quality assurance Quality management approach and the quality register Who is responsible for quality? Plans Need for plans and their hierarchy Approach to planning Content of a PRINCE2® plan Product-based planning Risk The need to manage risks What is a risk? Risk and continued business justification A risk management option Change Change is inevitable Different types of change Baselines and configuration management Issue and change control in PRINCE2® Progress Controlling a PRINCE2® project The application of tolerance Types of control Raising exceptions Introduction to Processes Processes and the project lifecycle The PRINCE2® journey Structure of the process chapters Tailoring the processes Starting up a Project Appointing people to the PRINCE2® roles Establishing some baselines Should we go further with this work? Planning for initiation Directing a Project Should we start / continue the project? Responding to internal / external influences Should we close this project? Initiating a Project Establishing the project's approaches Creating the project plan Refining the business case Assembling the PID Controlling a Stage Authorizing and reviewing work Monitoring and reporting Handling non-planned situations Triggering the next process Managing Product Delivery Accepting work from the Project Manager Getting the work done by the team Routine and non-routine reporting Handing back the completed work Managing a Stage Boundary Taking stock of what we have done Updating the PID Consider the options for continuing / stopping Producing exception plans Closing a Project PRINCE2® at the end of a project Transition of product to operational use How well did we do? Tying up all the loose ends
PRINCE2® Foundation Projects fail for a variety of reasons including poor planning, lack of defined quality criteria, poor understanding of the business drivers, inadequate control, and lack of senior management involvement in other words, lack of a structured best practice approach to project delivery. PRINCE2® (6th Edition is the current version) is a structured, process-based approach to project management providing a methodology which can be easily tailored and scaled to suit all types of projects. It is the de facto standard for project management in the UK Government and is used extensively in more than 150 countries worldwide with in excess of 20,000 organizations already benefiting from its powerful approach. It can be used easily in combination with PMI®'s PMBOK® Guideto provide a robust project management methodology, or to augment an existing PMBOK®-based methodology with additional rigor around areas such as Quality, Organization, and Benefits Realization. The goals of this course are to provide participants with a thorough grounding in PRINCE2® and its benefits and to prepare them to sit the Foundation exam. What you will Learn You'll learn how to: Identify the benefits and principles underlying a structured approach to project management Define the PRINCE2® method in depth, including the principles, themes, and processes Prepare and practice for the Foundation exam Getting Started Introductions Course structure Course goals and objectives Overview of the PRINCE2® Foundation exam PRINCE2® Introduction Introducing PRINCE2® The structure of PRINCE2® What PRINCE2® does not provide What makes a project a 'PRINCE2® project'? Project Management with PRINCE2® Defining a project Managing a project Controlling the variables The Project Manager's work PRINCE2 Principles PRINCE2® Principles The Seven Principles Tailoring and Adopting PRINCE2® Defining tailoring Defining embedding What can be tailored? Who is responsible for tailoring? Introduction to the PRINCE2® Themes What is a PRINCE2® Theme? What are the PRINCE2® Themes? Tailoring the themes Format of the theme chapters Business Case Need for a business case Elements of a business case How a business case is developed Managing Benefits Organization Need for a special type of organization PRINCE2® organization structure Roles in a PRINCE2® project Combining roles Quality Relevance of quality to project work Quality, quality control, and quality assurance Quality management approach and the quality register Who is responsible for quality? Plans Need for plans and their hierarchy Approach to planning Content of a PRINCE2® plan Product-based planning Risk The need to manage risks What is a risk? Risk and continued business justification A risk management option Change Change is inevitable Different types of change Baselines and configuration management Issue and change control in PRINCE2® Progress Controlling a PRINCE2® project The application of tolerance Types of control Raising exceptions Introduction to Processes Processes and the project lifecycle The PRINCE2® journey Structure of the process chapters Tailoring the processes Starting up a Project Appointing people to the PRINCE2® roles Establishing some baselines Should we go further with this work? Planning for initiation Directing a Project Should we start / continue the project? Responding to internal / external influences Should we close this project? Initiating a Project Establishing the project's approaches Creating the project plan Refining the business case Assembling the PID Controlling a Stage Authorizing and reviewing work Monitoring and reporting Handling non-planned situations Triggering the next process Managing Product Delivery Accepting work from the Project Manager Getting the work done by the team Routine and non-routine reporting Handing back the completed work Managing a Stage Boundary Taking stock of what we have done Updating the PID Consider the options for continuing / stopping Producing exception plans Closing a Project PRINCE2® at the end of a project Transition of product to operational use How well did we do? Tying up all the loose ends
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CWNA training course description A hands-on course focusing on the technical support of WiFi. Wireless LANs are often seen as simple communications that are simply installed and then left alone to work. This course ensures that delegates will be able to install WiFi networks which work but also enable the delegates to troubleshoot WiFi when it does go wrong. What will you learn Compare 802.11 standards. Configure WiFi networks. Troubleshoot WiFi networks using spectrum analysers, Wireshark and other tools. Implement 802.11 security. Perform RF surveys. CWNA training course details Who will benefit: Technical staff working with WiFi networks. Anyone wishing to pass the CWNA exam. Prerequisites: Intro to data communications & networking Duration 5 days CWNA training course contents Introduction History, standards. RF fundamentals What is RF? Wavelength, Frequency, Amplitude, Phase. Wave behaviour. RF components. Watts, mW, dB, SNR, Link budgets. Hands on Spectrum analysis. Listing WiFi networks. WiFi connection. inSSIDer. Antennas Radiation envelopes, polar charts, gain, Antenna types. Line of Sight, MIMO. Hands on Connecting, installing, changing antennae. RSSI values. 802.11 802.11-2007, 802.11 post 2007, 802.11 drafts. 802.11 b/g/n. Hands on WiFi performance measurement. Spread Spectrum RF frequency bands, FHSS, DSSS, OFDM. Channels. Hands on Configuring channels. Topologies Mesh, Access points, distribution systems, SSID. Hands on AP configuration. Client connection profiles. 802.11 MAC CSMA/CA, Management frames, control frames, data frames. Passive scanning, active scanning. Open system authentication. Shared Key authentication. Association. RTS/CTS. Power management. Hands on Capturing frames, analysing frames. WiFi architecture WiFi client, WLAN architecture: Autonomous, Centralised, distributed. WiFi bridges. WiFi routers. PoE. Hands on WLAN controllers. Troubleshooting RF interference, multipath, adjacent channels, low SNR, mismatched power. Coverage, capacity. 802.11 Security Basics, Legacy security: WEP, MAC filters, SSID cloaking. PSK, 8021.X/EAP, WPA/WPA2. TKIP/ CCMP encryption. Guest WLANs. Wireless attacks, intrusion monitoring. Hands on WEP cracking, WPA2 configuration. RADIUS. RF Site surveys Protocol and spectrum analysis, coverage analysis. Site survey tools. Hands on Performing a site survey.
CBT Japanese philosophy practical
This course will introduce you to the beautiful world of colour analogue photography. Taking as a starting point the work of contemporary photographic artists working with colour, we will discuss and explore theory as well as developing core skills essential for the capture and printing of your own colour images. You will learn how to correctly expose colour negative film and learn more about the characteristics of different types of film and the effects that they can have on an image. Within Stills’ darkrooms you will learn how to process your colour film by hand and print high quality analogue C-Type prints. Day 1 Morning: Colour Theory, Inspiration and Refresher for SLR Camera Controls During the morning we will be looking at contemporary photographers and artists that have used colour to inform their practice in specific ways. We will look at the ways in which colour revolutionized the artworld and vernacular photography. We will also look at basic colour theory, exploring which colours compliment each other and why. We will also refresh basic camera controls, load cameras and head out to the streets to shoot a roll of film. Afternoon: Colour Film Processing During this session, you will learn how to hand process your colour film. We will discuss the loading of the tank and the preparation of the machine to ensure correct processing temperature. We will look at different film types, why you may want to use them and the range of effects that can be produced. Day 2 Morning: Introducing the Colour Darkroom and Contact Sheets You will be introduced to Stills colour darkooms and become familiarised with the range of equipment you will be using. You will be taught how to set up your darkroom for printing, how the colour print processor works and how to print a contact sheet for viewing your negatives. Afternoon: Printing In the afternoon you will be expected to make a series of final C-Type prints. You will be shown techniques to improve your printing skills and produce the images you desire. This last session will allow you time to print with some one-to-one attention. We will discuss some printing techniques to help you get the most from your negatives. We will also have time at the end of the day to look back on all the work produced over the course and discuss it in relation to theory we learnt at the beginning. By the end of the course you will have: Learned more about colour theory and have a knowledge of contemporary artists working with colour photography Learned to process your own colour film Experimented with a variety of specialised darkroom printing techniques Printed contact sheets and a collection of colour photographs Feel confident in a colour darkroom using specialist equipment Courses are subject to minimum enrolment. Please register early, within five days of the start date, to reduce the likelihood of course cancellation. Please read our cancellation policy before booking. Students, anyone over the age of 65, and those in receipt of any form of benefits can claim the concessionary price, offering a 10% discount on the full course price. Valid proof of eligibility must be produced on the first day of the course. Please use the code CONCESSION when prompted at checkout.
Carrier Ethernet training course description Ethernet is now the interface of choice for nearly all networking. This comprehensive course looks at the ways carriers can provide this Ethernet interface for their WANs and MANs. The course assumes delegates already have a solid foundation in Ethernet switching and so concentrates on just the Ethernet technologies for Carrier Ethernet. What will you learn Describe the main Carrier Ethernet services. Evaluate transports for Carrier Ethernet. Explain how Ethernet can work over MPLS and SDH. Explain the Ethernet technologies used to enable Carrier Ethernet. Carrier Ethernet training course details Who will benefit: Network engineers. Staff working for carriers. Prerequisites: Definitive Ethernet switching for engineers. Duration 2 days Carrier Ethernet training course contents Introduction What is Ethernet? LANs, MANs, WANs, Ethernet and switches in the LAN. Traditional LAN/WAN integration, routers. The Ethernet interface for the WAN. Standards: IEEE, MEF, OIF, Ethernet Alliance. Carrier Ethernet Services E-line: EPL, EVPL. E-LAN: EP-LAN, EVP-LAN. E-Tree: EP-Tree, EVP-Tree. Ethernet Services attributes. Applications: Carrier Ethernet for businesses, Mobile backhaul. Multicasting. Service attributes Bandwidth profiles, bandwidth parameters, Class of Service, QoS, MTU, Protection mechanisms: STP, RSTP, MSTP, Link aggregation, G.8031, G.8032. Transporting Carrier Ethernet The main options. 'Pure' Ethernet, Ethernet over SDH, Ethernet over WDM, Ethernet over MPLS. Ethernet switching, addresses and MAC address tables. Carrier Ethernet access technologies. EFM. Ethernet over MPLS What is MPLS, MPLS-TE, MPLS-VPN, L2 VPNs, VPLS, VPWS. MPLS Fast Reroute. CET 'Pure' Ethernet, Provider bridging 802.1d, Provider Backbone Bridges 802.1ah. Traffic engineering 802.1Qay. Carrier Ethernet technologies 802.1ad VLAN stacking, 802.1AX Link aggregation. 802.1Q QoS. OAM Standards, layers, interworking
Advanced HP switches training course description A hands on course covering advanced features of HP switches. The focus of the course is on Layer 3 switching advanced features. Delegates will benefit the most from this course if they can supply us with their own configurations before the course. These configurations can then be used by the trainer in the course. What will you learn Configure and troubleshoot HP layer 3 switching. Configure and troubleshoot OSPF Harden HP switches. Explain the majority of their own configurations (if configurations are supplied to us before the course). Advanced HP switches training course details Who will benefit: Technical staff working with HP switches. Prerequisites: HP switches for engineers. Duration 2 days Advanced HP switches training course content Introduction VLAN review. Tagged and untagged ports. MSTP, PVST, UDLD, BPDU guard. Hands on VLANs, diagnostic tools debug, LLDP, remote port mirroring. L3 switching What are L3 switches? L3 lite, IPv4 and IPv6, routing protocols, routing tables. IP address on VLAN, no ip address on VLAN, connected interfaces, RIP. Hands on Routing between VLANs. Configuring and troubleshooting RIP. VRRP Default gateways, dead router detection, resilience. Hands on Configuring and troubleshooting VRRP. Static routes Why use static routes? Configuring static routes, default routes. OSPF Link state protocols, operation. Router types, LSA types, area 0. Hands on Configuring and troubleshooting OSPF. QoS Layer 2 QoS, 802.1Q, priorities, dscp mapping, rate limiting. Access lists Filtering traffic through the switch, controlling access to the switch, enabling and disabling ACLs, standard ACLs, extended ACLs Security DHCP snooping, ARP protection, STP guards, switch hardening. Summary Walkthrough of delegate configurations.