Whetstone Communications and comms2point0 are pleased to bring you the Data Bites series of free webinars. Our aim is to boost interest and levels of data literacy among not-for-profit communicators.
CRRUK equips professionals with the concepts, skills and tools to build conscious, intentional relationships, and to coach relationship systems of any size.
Data Protection and Clinical Trials
Course Information This course aims to empower you with the expertise to proficiently navigate process mapping and master the art of crafting Standard Operating Procedures (SOPs) within regulated environments. Whether you're engaged in activities that demand process improvement, continual enhancement, or SOP creation, this course offers invaluable insights tailored to your needs. It caters to individuals tasked with managing, documenting, and implementing processes and SOPs, irrespective of prior experience or skills. Our curriculum does not focus on specific software or approaches, focusing instead on fundamental principles and adaptable concepts applicable across diverse organisational landscapes. Benefits include: Hands-on experience in mapping processes An understanding of how process maps can be used to define, communicate and continually improve complex processes An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text An insight into the preparation of concise and user friendly SOPs. This course is structured to encourage delegates to: Discuss and develop ideas Develop a practical approach for creating process maps and writing SOPs Understand how to use process maps in SOPs effectively Discuss how process mapping for preparing SOPs can be applied to process improvement for SOPs. Is this course for you? The course is designed for all those with responsibility for managing, documenting and implementing processes and SOPs. It assumes no prior experience or skills. The course does not recommend any specific software or approach, but explores the principles and ideas that can be applied in any organisation. What will you learn? Hands-on experience in mapping processes An understanding of how process maps can be used to define, communicate and continually improve complex processes An understanding of best practice for SOPs using of process maps/process flow diagrams and process mind maps to complement text An insight into the preparation of concise and user friendly SOPs. By the end of the course you will be able to: Create process maps and write clearer more concise SOPs Understand how to use process maps in SOPs effectively Understand how process mapping can be applied to process improvement and better SOPs. Tutors Tutors will be comprised of (click the photos for biographies): Laura Brown Director, Laura Brown Training and Development David Butler VP of Quality, Resolian Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome, Introductions and Course Objectives Why Companies manage by process. 10:00 Exercise 1 - First Steps Mechanisms for process mapping, levels at which it can be applied, and the roles and responsibilities of process owners. 10:30 Exercise 1 - Feedback 10:45 Break 11:00 Mapping Processes The stages involved in mapping processes including how to construct a SIPOC chart. 11:45 Exercise 2 - Mapping A Process A first opportunity to practice your new process mapping skills. 12:30 Exercise 2 - Feedback 13:00 Lunch 14:00 Exercise 3 - Discussion of Options for Format, Structure and Layout What Makes A Good SOP? Discussion of options for format, structure, level of detail of SOPs and the use of process maps for SOP writing. A case study example of a good SOP which uses a flow chart/process map. 14:45 Exercise 3 - Feedback 15:00 Break 15:15 A Case Study example of a good SOP that uses a flow chart / process map 15:30 Exercise 4 Discussion of the content of an SOP using a Process Map 15:35 Exercise 4 - Feedback 15:45 Key Writing Considerations 16:15 Exercise 5 16:45 Exercise 5 - Feedback 17:00 Close of Day Day 2 09:00 Review of Day 1 09:15 Using Metrics Selecting and using metrics to monitor and improve processes. 10:00 Exercise 6 - Practice in Process Mapping Creating Process Maps from multi-source information. 11:00 Break 11:15 Exercise 6 - Feedback 11:45 Common Pitfalls Common problems and tips for good Process Mapping. 12:15 Demonstration of Process Mapping on a PC 12:45 Lunch 13:30 Exercise 7 - Mind Mapping 14:30 Exercise 7 - Feedback 15:00 Break 15:15 Exercise 8 - Using Process Maps to Write an SOP Applying your process mapping skills as part of writing an SOP 15:30 Exercise 8 - Feedback 15:45 Course Review and Follow-up 16:00 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. Development Level Learn
CRRUK equips professionals with the concepts, skills and tools to build conscious, intentional relationships, and to coach relationship systems of any size.
Motorsport is as much a business as it is a sport. Our new master’s programme will provide students with a broad range of modules which examine the national and international aspects of the industry from a commercial perspective. From governance, structure and international sports law, through to the importance and interdependence of commercial rights holders, promoters, manufacturer, teams, sponsors and the role played by the media, this course is aimed at enhancing the professional and career prospects of those with an aspiration of working within this exciting and challenging global industry. Our programme will help you to develop as professionals with a strong grounding in ethics and a clear sense of how motorsport relates to various cultures, stakeholders and the sectors it interacts with.
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
The COLP role goes beyond just ensuring your firm follows the rules in the SRA Standards and Regulations, it also comes with a personal accountability factor that demands your attention. Fear not! This 3 hour course will usher you through the intricacies of being a COLP, ensuring you not only meet but excel in your regulatory obligations. The course will cover: Navigating the Regulatory Landscape: Understanding the Framework for COLPs Dive into the intricate regulatory framework that Compliance Officers for Legal Practice (COLPs) operate under. Shouldering the Responsibility: Unpacking the Duties of a COLP Explore the multifaceted responsibilities that come with the role of a COLP. Choosing the Right Leader: Identifying the Ideal COLP Candidate Learn the criteria for selecting the most suitable individual to take on the crucial role of COLP. Cracking the Codes: Key Elements of Codes and SRA Principles Delve into the essential components of the Codes and SRA Principles that form the backbone of legal compliance. Building a Robust Foundation: Understanding Compliance Systems for All Firms Explore the concept of compliance systems, what they entail, and why every firm should have one in place. Reporting Matters: Recognising 'Serious' Issues, SRA Enforcement Strategy, and Reporting Protocols Uncover the definition of 'serious' matters, grasp the SRA Enforcement Strategy, and gain practical insights on making effective reports to the SRA. Paper Trails Matter: Effective Record Keeping, Including Non-material Breaches Master the art of comprehensive record-keeping, including strategies for recording non-material breaches, and understand why it's integral to compliance. Personal Liability: Understanding and Mitigating Risks Navigate the landscape of personal liability for COLPs and develop strategies to mitigate associated risks. Staying Ahead: Keeping Abreast of Regulatory Changes and Guidance Develop effective strategies for staying up to date with dynamic regulatory changes and evolving guidance. Planning for Compliance: Crafting a Robust Strategy, Assessing Risk, and File Reviewing Formulate a comprehensive plan for tackling compliance, including risk assessment, maintaining risk registers, and implementing effective file reviewing. Across the Board: Legal and Regulatory Compliance Areas Every COLP Must Master Gain a high-level overview of crucial legal and regulatory compliance areas, including AML, transparency rules, and other pivotal aspects that demand the attention of all COLPs. Target Audience This online course is suitable for those new to the COLP role, or those supporting the COLP and for those that would like a refresher of the role and their responsibilities. Resources Comprehensive and up to date course notes will be provided to all delegates which may be useful for ongoing reference or cascade training. Please note a recording of the course will not be made available. Speaker Helen Torresi, Consultant, DG Legal Helen is a qualified solicitor with a diverse professional background spanning leadership roles in both the legal and tech/corporate sectors. Throughout her career, she has held key positions such as COLP, HOLP, MLCO, MLRO and DPO for law firms and various regulated businesses and services. Helen’s specialised areas encompass AML, complaint and firm negligence handling, DPA compliance, file review and auditing, law management, and operational effectiveness in law firms, particularly in conveyancing (CQS).
The qualification is designed for learners who have responsibility for promoting health choices within the workplace, or who would like to get involved in championing workplace health. This level 2 course is delivered online across two sessions, both must be attended in order to achieve the qualification. Session 1: Introduction The importance of workplace health to employers and their employees The role of a Workplace Health Champion Factors affecting physical and mental health Session 2: Recap Key behaviour change principles The need to safeguard adults as a Workplace Health Champion Key elements involved in planning and preparing for a sport of physical activity session How to measure the success of a sport or physical activity session Tutor discussion / competence of qualification.