1606 Courses

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

The Placement Course for Professional Engineers in the Construction Infrastructure and Oil & Gas sectors aims to train engineers to become managers in Construction and Oil & Gas Companies who are able to manage business processes and construction site procedures.  The Placement Course for Professional Engineers Construction and Oil & Gas Sectors is accredited by CPD Certification Service in London. Accredited CPD training means the learning activity has reached the required Professional Development standards and levels. The learning value has been scrutinised to ensure integrity and quality. The CPD Certification Service provides recognised independent CPD accreditation compatible with global CPD requirements. The Course is delivered with the support of Multinational Companies operating worldwide.  Dirextra has more than 2,300 alumni engineers who have worked on the construction of major infrastructures around the world. There is no growth without engineers. Kick-start your career with a programme in Construction and Oil & Gas. Dirextra is a leader in the field of Construction Infrastructure, Oil & Gas and Engineering education. Next editions: 📅 26 April 2024⏰ 37esima edition📍 Manchester M4 1DZ (in presence) or live from remote Selection are now open please send your application form to master@dirextra.com Brochure Master Professional Engineers in Italian Brochure Master Professional Engineers in Spanish Brochure Master Professional Engineers in English Application Form Brochure Dirextra in English Brochure Dirextra in Italian Why Manchester? EMPLOYMENT OPPORTUNITIES The programme is supported by large Oil & Gas and Construction Infrastructure Companies operating all over the world aiming to hire young engineers. 100% successful placement in previous cohorts. DURATION AND TRAINING Total time: 1200 hours, of which 1000 are spent on work placement. - 2 months (200 hours) of training in the classroom, on personal study and the final thesis; - 6 months (1000 hours) of work on a Construction or Oil & Gas Site. Accommodation will be provided by the host company.  PROGRAMME MODULES Well delivered Training Course, complies with CPD criteria, Approved Construction Company Organisation and Strategies Oil & Gas Company Organisation and Strategies English for Construction Management Tendering International Procurement Project Management according to PMI Rules PM from Tender to Completion of works: A Real Case People Management Risk Management Planning Primavera P6 Cost Control Contract Management: from signing to testing Standard Contract Forms (FIDIC) and Claims Tunnelling and TBM (Tunnelling Boring Machine) Petroleum Engineering and Drilling (Wells and Rigs) QHSE of Construction Sites QHSE of Oil & Gas Sites PROGRAMME TEACHERS The teaching is assigned to experts with years of experience in the Construction and Oil & Gas industry coming directly from the sponsoring companies (entrepreneurs, general managers, project managers, technical managers, site managers, human resources managers, lawyers, etc.) REQUIREMENTS, PROCEDURES AND TERMS  Applying The Programme is aimed at graduates in Civil and Mechanical Engineering.However we will consider applications from all engineering graduates.Please be aware places are limited.Selection will be determined by qualifications. Fees and Financing Tuition fees £ 10,000. (pounds). Payment can be made in the following ways: in total at the time of registration (discount of £ 1,000 (pounds) in 4 instalments The Construction and Oil & Gas Companies sponsoring our Programme grant Scholarships to cover part of Tuition Fees. Scholarships are limited students who register in advance will receive a higher amount. Submit applications via email to master@dirextra.com For more information please call us. Our Staff will call you back within 24 hours, if not available. Office 0044 (0) 161 18808701 Mobile Eng. Carmen Andre' 0044 7765796588

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The Agile Project Manager Change isn't coming, it's already here. The project environment is becoming more volatile, uncertain, complex, and ambiguous. Project management and project managers must transform and evolve in order to keep up with these changes. Agile has been a disruptor in the field of project management, having over 20 years of successes and benefits to organizations that have adopted their frameworks. The Agile frameworks have proven themselves to be more adept in dealing with this uncertainty. But Agile isn't just about following a different way of working. What do you need to learn, do, and become in order to continue in the current and future environment? It is a powerful combination of knowledge, competencies, and mindset. In an increasingly complicated project environment, this course provides participants with the knowledge needed to not only survive but thrive. What you will Learn At the end of this program, you will be able to: Evaluate the changing project environment and the needed knowledge, skills, and behaviors Demonstrate innovative project manager competencies of leading change, servant leadership, and focus on value Utilize Lean and Agile principles to maximize value and improve project performance Construct a hybrid Agile model that is unique to your project Assess your role in Business Agility as an Agile Project Manager Getting Started Introductions Workshop orientation Expectations Foundations Recap: What is Agile? A changed project environment The future project manager Agile Project Management Competencies Focusing on value Championing change Servant leadership Coaching / mentorship Facilitation Lean and Agile Principles Optimizing flow Making things small Continuous planning Just-In-Time requirements Visualizing work Hybrid Agile Considerations Considering a Hybrid Approach Examining Strengths and Weaknesses of Each Approach Selecting Waterfall / Agile Roles, Practices, and Techniques Reviewing Three Hybrid Scenarios Constructing the Hybrid Project Implementing Agile Pitfalls and Concerns Agile in the Organization Business Agility

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OOAD training course description A workshop course providing thorough practical knowledge of object oriented analysis and design methods. What will you learn Perform Systems Analysis with Object Oriented methods. Identify key classes and objects. Expand and refine OO problem domain models. Design Class hierarchies using inheritance and polymorphism. Design programs with Object Oriented methods. OOAD training course details Who will benefit: System analysts, designers, programmers and project managers. Prerequisites: It is desirable that delegates have experience of programming in C++/Java or some other OOP language. Duration 5 days OOAD training course contents What is OO? Classes, objects, messages, encapsulation, associations, inheritance, polymorphism, reusability. What is Systems Analysis and design? Data flow diagrams, structure diagrams. The OO approach. OOA The problem domain and object modelling. Identifying classes and objects. Generalisation and inheritance. Defining attributes and methods. OOD Refining the OOA results. Designing the User Interface. Designing the algorithms and data structures using objects. Designing the methods. OOP Prototyping. Implementing OOD with OOPs and OOPLs.

Overview This course provides participants with the chance to focus on relevant project management tools and skills required to run successful projects in research and beyond. The course has been designed to help researchers and project managers enhance their project management skills in the context of their research and develop their knowledge of broader project management principles. The training course is highly participative and includes a peer learning session where participants will get the chance to tackle specific issues and challenges related to their research projects, find innovative solutions and share best practices.

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The Agile Project Manager Change isn't coming, it's already here. The project environment is becoming more volatile, uncertain, complex, and ambiguous. Project management and project managers must transform and evolve in order to keep up with these changes. Agile has been a disruptor in the field of project management, having over 20 years of successes and benefits to organizations that have adopted their frameworks. The Agile frameworks have proven themselves to be more adept in dealing with this uncertainty. But Agile isn't just about following a different way of working. What do you need to learn, do, and become in order to continue in the current and future environment? It is a powerful combination of knowledge, competencies, and mindset. In an increasingly complicated project environment, this course provides participants with the knowledge needed to not only survive but thrive. What you will Learn At the end of this program, you will be able to: Evaluate the changing project environment and the needed knowledge, skills, and behaviors Demonstrate innovative project manager competencies of leading change, servant leadership, and focus on value Utilize Lean and Agile principles to maximize value and improve project performance Construct a hybrid Agile model that is unique to your project Assess your role in Business Agility as an Agile Project Manager Getting Started Introductions Workshop orientation Expectations Foundations Recap: What is Agile? A changed project environment The future project manager Agile Project Management Competencies Focusing on value Championing change Servant leadership Coaching / mentorship Facilitation Lean and Agile Principles Optimizing flow Making things small Continuous planning Just-In-Time requirements Visualizing work Hybrid Agile Considerations Considering a Hybrid Approach Examining Strengths and Weaknesses of Each Approach Selecting Waterfall / Agile Roles, Practices, and Techniques Reviewing Three Hybrid Scenarios Constructing the Hybrid Project Implementing Agile Pitfalls and Concerns Agile in the Organization Business Agility