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About this Virtual Instructor Led Training (VILT) This 4 half-day Virtual Instructor Led Training (VILT) course presents the principles and best practices of portfolio management in the upstream (E&P) oil and gas industry. The VILT course is equally valuable for small independents, large integrated international companies and national oil companies. The VILT course consists of presentations, case studies, illustrative practical exercises and syndicate discussions. Particular emphasis is given to pragmatic portfolio management approaches and solutions which can be implemented swiftly without recourse to major investments in planning and portfolio management software. The VILT course will draw on examples from your expert course leader's 35+ years' experience in the oil and gas industry as an explorationist, upstream vice-president and management consultant. The VILT course handout will comprise softcopy slides used in the presentation and a softcopy workbook for the exercises. Participants will gain proficiency in portfolio management techniques, understand how and why to undertake this activity and be able to apply key concepts directly in the business of their teams / divisions. The VILT course will be presented over 4 half-days, using Microsoft Teams or Zoom and a proprietary set of VILT tools. Participants will be asked to complete a pre course questionnaire (PCQ) addressing their objectives and experience, and attend a session to familiarise themselves with VILT tools before course commencement. Training Objectives To present the tools, concepts and principles of portfolio management To define the quantitative metrics which are used to describe projects in a portfolio To understand the benefits of portfolio management at different stages of the upstream business: in strategy development, opportunity screening, business development, drilling prospects, conducting appraisal of discoveries and developing fields To put portfolio management in the organisational context by describing the role of the portfolio management team and examining how value assurance (quality control) is best conducted on portfolio data for projects and assets To demonstrate how portfolio management contributes to improved business performance By the end of the VILT course, participants will understand: Key concepts and principles of portfolio management How to design a simple portfolio database and describe complex projects in a small number of objective metrics How to segment the portfolio into meaningful units How to use portfolio data in making business choices and decisions at the strategic and tactical levels The extent to which it is meaningful and reasonable to make comparisons across different portfolio segments How the portfolio management team can support the wider business in decision-making Target Audience This VILT course is specially designed for exploration and development geoscientists, E&P economists and finance staff, and E&P managers. Both technical and non-technical staff will benefit from the concepts presented. Companies are encouraged to send participants from different functions and seniority levels to gain great benefits especially those which would like to implement the concepts presented in this VILT course. Course Level Basic or Foundation Training Methods The VILT course will be delivered online in 4 half-day sessions comprising 4 hours per day, with 2 breaks of 10 minutes per day. The VILT course will be presented in an interactive workshop format that allows for discussion. Course Duration: 4 half-day sessions, 4 hours per session (16 hours in total). Trainer Your expert course leader draws on more than 35 years of experience managing, reviewing and directing projects in all aspects of the exploration business: from exploration business development (new ventures), through prospect maturation and drilling, to the appraisal of discoveries. He has more than 30 years' experience with Shell International, followed by 10 years consulting to NOCs in Asia Pacific, Africa and South America and independent oil companies in the United Kingdom, continental Europe and North America. Other than delivering industry training, he has worked on projects for oil & gas companies of all sizes, including independents, national oil companies and (super)-majors, private equity firms, hedge funds and investment banks, and leading management consulting firms. He is an alumnus of Cambridge University. He has M.A and Ph.D. degrees in geology and is a Fellow of the Geological Society of London as well as a respected speaker on management panels at international conferences. Professional Experience Management consultancy & executive education: Advice to investment banks, businesses and major consulting firms. Specialist expertise in upstream oil & gas, with in depth experience in exploration strategy, portfolio valuation and risk assessment. Leadership: Managed and led teams and departments ranging from 3 - 60 in size. Provided technical leadership to a cadre of 800 explorationists in Shell worldwide. Member of the 12-person VP team leading global exploration in Shell, a $3 bln p.a. business and recognised as the most effective and successful among its industry peers. Accountability & decision-making: Accountable for bottom-line results: in a range of successful exploration ventures with budgets ranging from $10's million to $100's million. Made, or contributed to, complex business decisions / investments, taking into account strategic, technical, commercial, organisational and political considerations. Corporate governance: Served as non-executive director on the Boards of the South Rub al Khali Company (oversight of gas exploration studies and drilling in Saudi Arabia) and SEAPOS B.V. (exploration deep-water drilling and facilities management). Technical & operations: Skilled in exploration opportunity evaluation, the technical de risking of prospects, portfolio analysis and managing the interface between exploration and well engineering activities. Unparalleled knowledge of the oil and gas basins of the world, and of different operating regimes and contractual structures, ranging from Alaska, Gulf of Mexico and Brazil, through to the Middle East, former Soviet Union, Far East and Australia. Safety: Following an unsatisfactory audit, became accountable for safety performance in Shell's exploration new ventures. Through personal advocacy and leadership of a small team, delivered pragmatic and effective HSE systems, tools and staff training / engagement and a dramatically improved safety record. R&D: Experience in the 3 key roles in R&D: scientific researcher, research manager, and 'customer' for R&D products. After re-defining Shell's exploration R&D strategy, led the re-structuring of the R&D organization, its interface with 'the business' and approaches to deployment and commercialization. Strategy: Accomplished at formulating competitive strategies in business, R&D and technology deployment, translating them into actionable tactics and results. Defined the exploration strategy of PDO (a Shell subsidiary in Oman) and latterly of Shell's global exploration programme. Professional education, behavioural/motivational coaching: Experienced in organisational re-design, change management, leadership education and talent development. Commercial skills: Personally negotiated drilling compensation claims, educational contracts and E&P contracts, with values of $5 million to $100+ million. 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 about post training coaching support and fees applicable for this. Accreditions And Affliations
This course is for anyone wishing to understand their strengths and development areas and those who are seeking assistance to progress their careers and convey their abilities confidently.
This is a practical ‘non medical’ day for front line practitioners working with children and young people with serious attachment issues arising from loss, trauma and abuse. We look at what Psychology may help us in our understanding of children who have faced issues with love and attachment. Splitting, handling projected feelings, constancy and permanence are explored. Online Course now available via Teachable Platform – Understanding Attachment Learn at your own pace… lots of text and video support Course Category Meeting emotional needs Behaviour and Relationships Inclusion Teaching and Learning Description This is a practical ‘non medical’ day for front line practitioners working with children and young people with serious attachment issues arising from loss, trauma and abuse. Drawing from the international research and literature and our own experience over many years as educational psychologists of the challenges of children with major social and emotional needs, we will explore together what the best practice can and could look like. We explore the language of attachment and outline very practical classroom strategies. We look at what Psychology may help us in our understanding of children who have faced issues with love and attachment. We explore the feelings of being on a desolate island of relational poverty or to imagine swimming with sharks. We explore the themes of violence, anxiety and experience of being a victim as young people grow older. We look at telling lies and explore how we can respectfully understand this. We reveal the new and innovative compass of vulnerability – the cognitive errors to which some are much more vulnerable. We look at triggers, self regulation and unpack a range of strategies. Transference and counter transference are examined along with splitting, handling projected feelings, constancy and permanence. We explore what young people with these difficulties really need from us. We also spend time looking at the emotional impact on practitioners working with children with such needs and what helps at an personal and team level. We can all do something – we do not have to wait for expert therapists to arrive! Testimonials Very moving presentation I will always try and think behind the behaviour now It had a huge impact on all levels We all seem to need it Belonging and feelings are so important Very user friendly Excellent! Learning Objectives Increased confidence regarding developing inclusive practice for children with serious attachment needs in mainstream schools Simple understandable explanation of attachment understood Access to a wider range of practical strategies to impact on social and behavioural needs Deeper understanding of core values surrounding inclusion of emotionally disabled children Opportunity to reflect on professional attitudes and behaviour towards parents and pupils with complex emotional needs New skills, scripts and processes to make inclusion successful Who Is It For ? Practitioners working in schools and other settings with children and young people of all ages Key workers Teaching Assistants with support roles Heads and deputies SENCOs Advanced skills teachers Primary and secondary classroom teachers Parents Local authority support services Course Content The course explores the questions : How can we start to develop an understanding of children with attachment needs? What is the true impact of loss, trauma and abuse? What else can we do to go about including high profile children or young people with challenging emotional needs? What useful psychological constructs can we use to guide us? This course also explores practical strategies and language for key adults rebuilding relationships with individual pupils. This is a participative day that aims to be explorative and practical. Opportunities to develop empathy with the children of concern will be created.
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This is a practical ‘non-medical’ day for front line practitioners working with children and young people who have experienced serious trauma in their life. We work to strengthen understanding of children who have faced issues of trauma emerging from abuse, violence, loss and family breakdown. Online Course now available via Teachable Platform – Impact of Trauma Learn at your own pace… lots of text and video support Course Category Meeting emotional needs Behaviour and Relationships Inclusion Teaching and Learning Description This is a practical ‘non-medical’ day for front line practitioners working with children and young people with serious issues arising from trauma. Drawing from the international research and literature and our own experience over many years as educational psychologists of the challenges of children with major social and emotional needs, we will explore together what the best practice can and could look like. We explore the language and key concepts of trauma and outline very practical classroom strategies. We look at what Psychology may help us in our understanding of children who have faced trauma. We explore the themes of: Hyperarousal Intrusive thoughts Constricted lives We look at triggers, self-regulation and unpack a range of strategies. We explore what young people with these difficulties really need from us. We also spend time looking at the emotional impact on practitioners working with children with such needs and what helps at a personal and team level. We can all do something – we do not have to wait for expert therapists to arrive! Testimonials I had no idea… It had a huge impact Belonging and feelings are so important Excellent! Learning Objectives Increased confidence regarding developing inclusive practice for traumatised children in mainstream schools Simple understandable explanation trauma understood Access to a wider range of practical strategies to impact on social and behavioural needs Deeper understanding of core values surrounding inclusion of emotionally disabled children Opportunity to reflect on professional attitudes and behaviour towards parents and pupils with complex emotional needs New skills, scripts and processes to make inclusion successful Who Is It For? Practitioners working in schools and other settings with children and young people of all ages Key workers Teaching Assistants with support roles Heads and deputies SENCOs Advanced skills teachers Primary and secondary classroom teachers Parents Local authority support services Course Content The course explores the questions:What does it take for a child to:Feel safe and secureMourn the past traumaReconnect with ordinary relationships with children and adults?How can we start to develop an understanding of traumatised children?What is the true impact of trauma?What else can we do to go about including high profile children or young people with challenging emotional needs?What useful psychological constructs can we use to guide us?This course also explores practical strategies, concepts and language for key adults rebuilding relationships with individual pupils.This is a participative day that aims to be explorative and practical. Opportunities to develop empathy with the children of concern will be created.If you liked this course you may well like:FRESH APPROACHES TO BEHAVIOUR AND RELATIONSHIPS
When it comes to writing a research paper, the discussion chapter is where the magic happens. It's not just about presenting your findings; it's about showcasing them in a way that resonates with your audience. You want to take your readers on a journey through your research, helping them understand not just the results but their significance as well. In this article, I’ll share some essential tips on how to effectively showcase your research in the discussion chapter, ensuring that your hard work gets the recognition it deserves. Understanding the Discussion Chapter Definition and Role So, what exactly is the discussion chapter? Think of it as the heart of your research paper. Here, you interpret and analyze your results, linking them back to your research questions. It’s the section where you reveal the implications of your findings and discuss their relevance in the broader context of your field. If you’re wondering how to navigate this crucial part, check out our guide on How To Write a Dissertation Discussion for a detailed approach. Differences from Other Chapters Unlike the results chapter, which focuses on presenting data, the discussion is where you dive deeper into what those results mean. It’s about connecting the dots and making sense of the numbers. You’re not just stating what you found; you’re telling a story about why it matters. Structuring Your Discussion Organizing Key Points A well-structured discussion is crucial for effectively showcasing your research. Start by organizing your key points logically. This might mean discussing each research question in turn or grouping findings by theme. Whatever structure you choose, ensure it flows naturally from one point to the next. Using Subheadings Don’t underestimate the power of subheadings. They guide your reader through your discussion, making it easier to follow your train of thought. Subheadings also break up the text, making your discussion more visually appealing. Interpreting Your Findings Analyzing Results Now comes the fun part: interpreting your findings. Take a close look at your results and analyze them thoroughly. What trends do you see? Are there any surprising outcomes? This is your chance to showcase your critical thinking skills and provide insights that go beyond the data. Linking to Research Questions Always link your interpretations back to your research questions. This creates a cohesive narrative and reinforces the significance of your work. By showing how your findings answer these questions, you strengthen your argument and highlight the relevance of your research. Contextualizing Your Research Comparing with Previous Studies To truly showcase your research, it’s essential to place it within the context of existing literature. Compare your findings with previous studies and discuss how they align or diverge. This not only shows your understanding of the field but also underscores the contributions your research makes to the ongoing conversation. Highlighting Unique Contributions Don’t be shy about highlighting what makes your research unique. What new perspectives or insights do you bring to the table? By emphasizing these contributions, you demonstrate the value of your work and why it deserves attention. Discussing Implications Practical Applications What can your findings be used for in the real world? Discussing practical applications is a great way to showcase the impact of your research. Whether it’s informing policy decisions, guiding future research, or improving practices in your field, make sure to highlight these implications. Theoretical Implications In addition to practical applications, consider the theoretical implications of your research. How does it contribute to existing theories or frameworks? Discussing these implications can elevate your work and showcase your understanding of the broader context. Addressing Limitations Acknowledging Weaknesses Every research project has its limitations. Acknowledging these weaknesses shows integrity and a nuanced understanding of your work. Discuss what limitations might affect the interpretation of your results and how they could be addressed in future research. Suggestions for Future Research Don’t just stop at acknowledging limitations—offer suggestions for future research. What questions remain unanswered? What directions could future studies take? This not only demonstrates your critical thinking but also positions your work as a stepping stone for others. Using Visual Aids Charts and Graphs Visual aids can be a powerful tool for showcasing your research. Use charts, graphs, or tables to present your data in a way that’s easy to understand. Visuals can help highlight key findings and make complex information more digestible. Effective Data Presentation Ensure that your visuals are clear and well-labeled. A confusing graph can detract from your discussion rather than enhance it. Take the time to present your data effectively, and your readers will appreciate the effort. Incorporating Feedback Utilizing Peer Reviews Feedback from peers can be invaluable when writing your discussion chapter. Don’t hesitate to seek out input from colleagues or mentors. Their insights can help you refine your arguments and enhance the clarity of your writing. Adjustments Based on Critiques Once you receive feedback, be open to making adjustments. Sometimes, outside perspectives can reveal blind spots in your reasoning or highlight areas for improvement that you might not have considered. Engaging Your Audience Writing Style and Tone Your writing style plays a significant role in engaging your audience. Aim for a conversational tone that invites readers in. Avoid jargon where possible, and strive for clarity in your explanations. Rhetorical Questions for Engagement Using rhetorical questions can be an effective way to engage your readers. It prompts them to think critically about the points you’re making and can make your discussion feel more interactive. Proofreading and Editing Importance of Clarity Once you’ve drafted your discussion, take the time to proofread and edit. Clarity is key; a well-written discussion is much easier to follow. Check for grammatical errors, awkward phrasing, and ensure your arguments flow logically. Common Mistakes to Avoid Watch out for common pitfalls, such as over-explaining or being too vague. Aim for a balance that conveys your insights without overwhelming your reader. Conclusion In conclusion, showcasing your research in the discussion chapter is all about clarity, context, and engagement. By structuring your discussion thoughtfully, interpreting your findings, and addressing limitations, you can effectively communicate the significance of your research. Remember, this is your chance to shine and demonstrate the value of your hard work. FAQs What is the purpose of the discussion chapter? The discussion chapter interprets the results of your research, linking them back to your research questions and placing them in the context of existing literature. How do I interpret my findings effectively? Analyze your results, identify trends, and connect them back to your research questions to demonstrate their significance. Should I include limitations in my research? Yes, acknowledging limitations shows integrity and a nuanced understanding of your work. It also opens up avenues for future research. How can I make my discussion engaging? Use a conversational tone, incorporate rhetorical questions, and structure your arguments clearly to keep your audience interested. What are common pitfalls to avoid in this chapter? Be cautious of over-explaining, using jargon, or failing to connect your findings back to your research questions.
About this Training Course In turbulent times for the entire Energy Sector, Oil & Gas E & P segments are coming under tremendous pressure to reinvigorate. Oil Majors like Shell Plc are no longer termed as Oil & Gas Company but also branded as SHELL Energy, with technology at its forefront. The Risks, Scope and Context of Engineering, Procurement, Construction, Installation and Commissioning (EPCIC) Projects is evolving rapidly. Thus, the success of a project is dependent on the practical 'know how' in scoping, contract drafting, negotiation and execution competencies. Understanding the essential ingredients of contracts and mastering the international contracting principles will equip the participants to identify vague and ambiguous clauses, avoid dangerous and often hidden terms, and better understand the controlling position in a project. In this 3 full-day course, the participants will find out how to negotiate legacy contracts where parties are not allowed to edit any clauses during the bidding process. The participants will learn from the Case Law Reports and analysis to take home lessons learned from bitter experiences of their peers in the industry. It is designed to help those who need a solution to manage current contractual issues or those who execute contracts regularly and want to be more proficient in managing their contracts and projects, with changing contexts. The course is developed with the underlying objectives for the participants to: Enhance their current knowledge of the legal principles governing international Contracts from formation, execution to breaches, redresses and dispute resolution either as a party or as a consortium member or as a coverture. Manage Consortium and Joint Venture Partners inter-relationship and contractual responsibilities. Identify dangerous exposures due to joint and severally liable requirements of consortium-based contracts. Effectively Manage Risks of Projects, with Enforceable Contract Documents, by learning the purpose and potential benefits of maintaining evidence in compliance to the contract clauses. Learn the Contract Enforcement Nuggets of Owners and the Variation Claims Strategies of the Contractors. Allocation of contract management related roles / assignments and WBS within consortium partners for effective project management and profitable results. Use of Contract Terms & Conditions for enhancing project performance, monitoring, reporting, and achieving timely completion, thereby avoiding delays and disputes. This course can also be offered through Virtual Instructor Led Training (VILT) format. Training Objectives Upon completion of the course, the participants will have learnt: Project management strictly in accordance with the contract and the corporate strategies. How to ensure that Variations Order claims are appropriately managed in turnkey and lump-sum contracts. Manage contemporary challenges and market factors with direct or indirect impact on the contracts. Managing all members of the Supply Chain from vendors to logistics services providers. Cost Engineering and Performance Management. How to manage Consortium Partners, Contractors, and Owner's representatives. When and how to obtain / grant extension of time (EOT) and costs. Ability to identify rights and obligations of each party to a contract instead of making subjective decisions. Ability to be firm in negotiations without violating terms of the agreements. Ability to spot different legal systems, contract laws and arbitration rules. Ability to negotiate and avoidance of disputes and resolution in amicable manner, in accordance with the provisions of the contract. Competency in developing and maintaining documentary evidence and traceability for all works executed during the project. Target Audience This course is specially curated for professionals from International Oil & Gas Industries including Offshore & Marine Sectors. They include the heads of strategic business units, contracts managers, project directors, project managers, general managers, corporate legal counsels, procurements and supply chain managers, lawyers and legal professionals engaged in the EPCIC Segments of the Oil & Gas Industry. Course Level Intermediate Trainer Principal Management Consultant Chartered Valuer and Appraiser (CVA) FACICA | FAMTAC | FAIADR | M.S.I.D | Member, AIEN LL.M. (IP Law), M. Sc. (Maritime Studies), M. Tech (Knowledge Engineering), MBA, First Class CoC (MCA, UK), B. E. (Elect) Your expert course leader, during the last 47 year period, has worked and consulted in the industry verticals encompassing: Technology, Oil & Gas Exploration & Production, Petrochemical Process Plants and Power Plant Construction Projects, Logistics & Warehousing, Marine, Offshore, Oil & Gas Pipelines, Infrastructure Development Projects (Ports, Offshore Supply Bases, Oil & Gas Terminals and Airports etc), EPCIC Contracts, and Shipyards, in South East Asia, Africa, Middle East, Americas and Europe. He serves as the Principal Management Consultant with a management consultancy in Hong Kong and Singapore, specialising in the fields of corporate management consultancy, international contracts reviews and alternative dispute resolutions services. He undertakes special assignments for conducting audits and valuation of intangible properties involving proprietary processes for licensed production, and licensing of intellectual property rights (IP Rights) in patents, trademarks, and industrial designs. He is frequently engaged for assignments like due diligence, acquisitions, mergers, resolving various operational issues, technology transfer and agency services contracts reviews, cost controls, and enhancement of Supply Chain Management. He has been conferred the credentials of Chartered Valuer & Appraiser (CVA) by SAC and IVAS, in accordance with the international valuation standards setting body IVSC. His consulting experience includes Charterparty Management, Business Process Re-engineering, Diversifications, Corporate Development, Marketing, Complex Project Management, Feasibility Studies, Dispute Resolutions and Market Research. He has successfully assisted Marine and offshore E & P clients in managing contractual disputes arising from various international contracts for upgrading & conversion projects. He continues to be actively engaged in claims reviews, mediation, arbitration, litigation, and expert witness related assignments, arising from international contracts and Charterparty Agreements. He graduated with a Bachelor's degree in Electrical Engineering, MBA in General Management, Master of Technology in Knowledge Engineering, Master of Science in Maritime Studies, and LL.M. (IP Law). He also holds professional qualifications in Business Valuations and Appraisers for CVA, arbitration, law, and marine engineering, including the Chief Engineer's First-Class Certificate of Competency (MCA, UK). He is further qualified and accredited as Certified International Arbitrator, Chartered Arbitrator, Sports arbitrator under CAS Rules, WIPO Neutral, Australian Communications and Media Authority (ACMA) Bargaining Code Arbitrator, Accredited Adjudicator and Accredited Mediator (Malaysia). He is admitted to the international panels of arbitrators and neutrals with WIPO, Geneva; ACICA, AMTAC and ACMA, Australia; BVIAC (British Virgin Islands); JIAC (Jamaica); HKIAC Hong Kong; AIAC, Malaysia; AIADR, Malaysia; KCAB, Seoul, South Korea; ICA, Delhi, India; ICC (Singapore); SISV, Singapore; SCMA, Singapore; SCCA, Saudi Arabia; VIAC Vienna, Austria; Thailand Arbitration Centre (THAC), and Mediator with AIAC Malaysia, CMC, and SIMI Singapore. 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 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