Course Information Our comprehensive course is used as a gateway to those stepping into the world of auditing clinical studies. Tailored for those already acquainted with Good Clinical Practice (GCP) and those transitioning from other audit disciplines, this programme stands as a pivotal guide. Pre-existing knowledge of GCP will significantly enhance your learning experience in auditing against these guidelines. How is this course run? Engage in immersive workshops providing hands-on practice with auditing techniques in a GCP context. Our seasoned tutors, boasting extensive audit experience, intertwine theory with practical insights drawn from their own professional journeys. What will I learn? A comprehensive understanding of the historical backdrop and objectives driving Good Clinical Practice, incorporating the latest industry developments Solid grounding in quality assurance activities aligned with regulatory standards Insight into potential pitfalls within clinical trials and the pivotal role of auditors in addressing these issues Clarity on the roles and responsibilities inherent to clinical trials auditing Exposure to a diverse range of audit techniques complemented by illustrative examples and supportive documents A nuanced understanding of regulatory inspectors' activities Expanded professional networks to propel your auditing career forward. Benefits include: A clear understanding of the role of the auditor under Good Clinical Practice improved audits Improved Good Clinical Practice compliance for your clinical trials. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of Good Clinical Practice. Tutors Tutors will be comprised of (click the photos for biographies): Rosemarie Corrigan EVP Global Quality, Worldwide Clinical Trials Cathy Dove Director and Owner, Dove Quality Solutions Julie Kelly Associate Director, Clinical Quality Assurance, Corcept Therapeutics Susana Tavares Director of Research Quality Assurance, - Programme Please note timings may be subject to alteration. Day 1 12:30 Registration 13:00 Welcome and Objectives for the first day of the course 13:30 Laying the Foundations Introduction to the clinical development process, the concepts of quality assurance, quality control and audit. 14:30 Break 15:00 Patient Protection Requirements for informed consent and ethics committee. Access to source documentation. Including a patient protection exercise. 16:05 Workshop 1 - Case Study on Informed Consent 16:45 End of Day Questions and Answers 17:00 Close of Day Day 2 08:50 Questions and Answers from Day 1 09:00 Effective Site Audits The procedures involved in selecting and setting up audits at investigator sites. 09:40 Workshop 1 - Planning the Effective Audit 10:30 Break 10:45 Source Data Verification The need for and purpose of verifying data. 11:25 Workshop 2 - Source Data Verification 12:30 Lunch 13:30 IMP Management The requirements surrounding the distribution of investigational medicinal products. Accountability from release to destruction. 14:15 Critical Document Audits The conduct of other study specific audits including protocols, databases and reports. 15:00 Break 15:15 Non-compliance Determining the acceptability of data. 16:00 Fraud - Fact or Fiction? How to identify fraud and its consequences 16:45 End of Day Questions and Answers 17:00 Close of Day Day 3 08:50 Questions and Answers from Days 1 and 2 09:00 Auditing Third Parties A review of audits of contract research organisations. 10:00 System Audits The concept of auditing processes across many clinical trials, including a practical exercise in process mapping. 10:45 Break 11:00 Workshop 3 - Process Mapping 11:45 Effective Audits Where theory meets reality. 12:30 Lunch 13:20 Audit Reports - Closing the Loop An examination of the processes which follow the evidence gathering phase of the audit. 14:20 Workshop 4 - Audit Reports Audit reports, corrective and preventive action. 15:00 Break 15:10 Regulatory Inspection Auditors and regulatory inspections -how the QA team can help the organisation to perform during a regulatory inspection. 15:55 Final Questions and Answers 16:10 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 17 Points Development Level Develop
Course Information Our extensively proven course delves into the essential stages of process and system auditing. Gain invaluable insights and direction in auditing systems and processes, spanning across global and local organisational levels. This course will assist delegates with: A practical approach for the development and conduct of process and system audits An enhanced understanding of key system audit principles, preparation, design and conduct Increased expertise, efficiency and confidence. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Share knowledge and experiences. By the end of the course delegates will be better able to: Design and plan more effectively to achieve their process and systems audit objectives and add value to their organisation Improve the effectiveness, focus and credibility of the audit programme Understand the key system audit principles, preparation, design and conduct Develop system audit tools to ensure more effective audit conduct and outcome Create audit strategies utilising risk management principles Prepare for inspections. Tutors Tutors will be comprised of (click the photos for biographies): Allison Jack Executive Director, Bristol Myers Squibb Rocio Castellanos Director, Pfizer Ltd Guy Houben G(C)LP Auditor, Janssen Pharmaceutical Companies of Johnson & Johnson Programme Please note timings may be subject to alteration. Day 1 08:50 Registration 09:00 Welcome and Introductions, Expectations/Challenges/Experiences A discussion to explore the range of approaches to the conduct of systems audit. 09:30 Introducing Systems Audit What is a system? Why conduct system audits? Advantages, disadvantages and challenges. 10:20 Break 10:35 Systems Audit Design and Planning Identifying the customer, setting objectives, development of the audit plan and audit tools, plans for the audit report. 12:00 Designing System Audit Tools 12:45 Lunch 13:30 System Audit Plan - Exercise 14:00 Introduction to Case Studies The objectives of the case studies are defined and process and outputs described. 14:15 Case Studies - Session 1 A first opportunity for work on case studies. Defining objectives and scope and understanding the requirements of the audit client. 15:00 Break 15:20 Case Studies - Session 1 continued 16:30 Case Studies - Feedback 17:00 Close of Day 1 Day 2 09:00 Simple System Audit Example - Introduction The objectives of the case studies are defined and process and outputs described. 09:10 Case Studies - Session 2 - A Simple System Audit Example An example of system audit applied to a simple system. 10:30 Break 10:45 A Simple System Audit Example - Case Study Feedback 11:30 Strategy Audit programme planning. 12:15 Lunch 13:00 Case Studies - Session 3 Work on delegate's case studies. 14:30 Break 14:45 Case Studies - Session 3 - Feedback 15:15 Closing remarks 15:30 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
Course Objectives At the end of this course you will be able to: Manage project costs Consolidate and reuse project plan information Exchange project plan data with other applications Update a project plan Customise Project to meet specific requirements ' 1 year email support service Take a look at the consistent excellent feedback from our corporate clients visiting our site ms-officetraining co uk Customer Feedback Really useful and engaging course. Learnt a lot that will be very beneficial in my job. Trainer was great. Kelly Moreley - TACT Very happy with the course. Worked as a good refresher from what I knew already and enhanced my knowledge further Jenny Price - Acer ' With more than 20 years experience, we deliver courses on all levels of the Desktop version of Microsoft Office and Office 365; ranging from Beginner, Intermediate, Advanced to the VBA level. Our trainers are Microsoft certified professionals with a proven track record with several years experience in delivering public, one to one, tailored and bespoke courses. Our competitive rates start from £550.00 per day of training Tailored training courses: You can choose to run the course exactly as they are outlined by us or we can customise it so that it meets your specific needs. A tailored or bespoke course will follow the standard outline but may be adapted to your specific organisational needs. Exchanging Project Plan Data with Other Applications Import a list of tasks from Outlook Import a Task List from an Excel File Create a Custom Import Map Export Project Plan Cost Data into Excel Save Project Plan Information as a Web Page Updating a Project Plan Enter Task Progress Information View Task Progress Split a Task Reschedule a Task Creating Custom Fields Text fields Lookup fields Calculated fields with the use of formulas and functions Inserting Graphical Indicators Customizing how you look at data Filter Tasks in a Project Plan Create a Custom Table Create a Custom View Copy custom Views and Tables between projects Earned value analysis Understanding Earned Value Fields View Multiple Baselines in a Single Project Tracking progress between interim plans Creating Custom Reports Create a Custom Report Modify a Custom Report's Header and Footer Add a Picture to a Report Modify a Custom Report's Margins Print a Custom Report Re-using Project Plan Information Create a Project Plan Template Create a Custom Combination View Make Custom Views Available to Other Project Plans Share Resources between Projects, Create a Master Project Plan with sub projects Who is this course for? Who is this course for? This course is designed for those that who already have the skills to create and modify project plans and would like to acquire a more in depth and thorough knowledge of more advanced functionalities in project planning and tracking. Requirements Requirements Preferably, delegates would have attended the MS Project Introduction course. Career path Career path Microsoft Office know-how can instantly increase your job prospects as well as your salary. 80 percent of job openings require spreadsheet and word-processing software skills
Certified Scrum Professional®-ScrumMaster® (CSP®-SM): In-House Training Certified Scrum Professionals challenge their teams to improve the way Scrum and Agile principles are applied. They have demonstrated experience, documented training, and proven knowledge in Scrum. Are you ready to take your knowledge and skillset in your role as Scrum Master to the next level? If so, it's time to elevate your career further by earning the Certified Scrum Professional®-ScrumMaster (CSP®-SM) certification. What you will Learn Learn to find practical solutions and improve your implementation of Scrum in the workplace. Aside from the pride gained and earning potential of attaining CSP® level, you can also: Attend exclusive CSP® events with other leaders in Scrum and Agile Attract more recruiters and command a higher rate of pay Establish a gateway and milestone toward becoming CST®, CEC, or CTC Receive a free premium subscription to the world's largest Agile assessment and continuous improvement platform, Comparative Agility®
Building High-Performance Teams: In-House Training This course pulls together the most current and popular theories and writings on this complex topic and presents this amalgamated view in a highly interactive workshop and activity-based approach. Students will understand and have the skills required to build and participate in high-performance project teams and will possess the insight to proactively affect change within their respective organizations by guiding the existing culture to one that promotes high performance. What you will Learn At the end of this program, you will be able to: Define a team and describe the optimum team size for effective performance Describe characteristics and guiding behaviors of high-performance teams Describe the major elements of each development stage in two distinct models Recognize cultural barriers in achieving high performance List the attributes of a high-performing corporate culture Assess your own corporate culture Discuss corporate leadership as a factor in building high-performance project teams Describe the three A's of selecting team members State three leadership responsibilities Describe leadership responsibilities, styles, and roles List and describe the eight components of the team charter model for building high-performance teams Foundation Concepts The Nature of Teams Characteristics of High-Performance Teams Understanding Team Development Stages of Team Development - Model 1 Stages of Team Development - Model 2 Designing a High-Performance Culture Corporate Cultures Corporate Leadership Establishing the Attributes of High Performance Choosing the Right People Team Effectiveness Team Leadership The Team Charter Model
NPORS Rigging and Fleeting Loads Lift Planner (N046)
SMART Improvement Planning & Implementation
EQ is a pattern of how people's biases in their thinking leads them to think one choice or thing is better than another, as well as their clarity in differentiating within those biases to exercise clear and sound judgement. Where your thinking and responses lie within your biases spectrum, and your ability in adjusting to the situation you find yourself in, will determine responses equating to poor or strong Emotional Intelligence (EI). This course will enhance and promote the skill set necessary for any working leader or manager, allowing our in-depth emotional intelligence knowledge to be applied into your working environment. From an employer's perspective, this award can be a significant long-term return on investment by further developing your leaders and managers. What Does This Course Offer? Our program offers an EQ-SWOT™ assessment and EI Model in detail, and through activity and discussion we explore how applying and possibly adjusting, you may offer an improved Emotional Intelligence. Our learning experiences are successful because the outcomes are quickly embedded and demonstrate an immediate visible impact on the day-to-day working environment. Our engaging learning inspires employees to want to personally add value to the companies they work for. We also offer our Paradigm EQ-SWOT™ online assessment and report as a frame of reference within the program. This assessment should be completed before attending the program, and will be expanded upon during the program delivery. Course Content The Emotional Intelligence for Today’s Leadership and Management course covers the following topics: What makes EI so important within the workplace Self-Awareness and your EQ Profile The EQ unpacked Unconscious Bias & EI How to develop your EI quotient Accreditation Activity Our accredited tutors deliver training that encourages delegates to confidently and practically apply all they have learnt as soon as they get back into the business. To achieve this award, delegates need to prepare and deliver a 3 minute presentation* on the highlights of their learning and immediate application avenues when back in their working environment. *Participants will be given 30 minutes during the program to prepare for their 3 min presentation at the end of the program. Scheduled Course Dates Unfortunately this course is not currently scheduled as an open course as it is primarily run as an in-house programme. For more information, please contact us. In-House Courses This is our own management training course which has been developed and refined over the many years we have been providing it to delegates from organisations in virtually every industry. This means that the course syllabus is extremely flexible and can be tailored to your specific requirements. If you would like to discuss how we can tailor this management training course for you and/or run it at your premises, please contact us.
This programme is aimed at helping participants to manage their time more effectively and to be more productive with the time available to them.