10 Process Mapping courses in London

The “ISO 20000: 2018 Lead Auditor” course provides comprehensive training in the ISO 20000: 2018 standard and all its requirements from the Lead auditor’s point of view, as well as basic skills necessary to Lead audit activities. It’s a practical-oriented training that should be considered “a must” for every ISO 20000: 2018 Lead auditor. The interactive training program, complete with quizzes, will provide the necessary technical knowledge and understanding of all ISO 20000: 2018 requirements to implement the requirement of the standard and complete ISO 20000: 2018 audit . This ISO Lead auditor training should be taken by individual with interest in conducting internal as well as third part audits according ISO 20000: 2018 standards.

The “ISO 9001:2015 Lead Auditor” course provides comprehensive training in the ISO 9001:2015 standard and all its requirements from the auditor’s point of view, as well as basic skills necessary to complete an internal audit. It’s a practical-oriented training that should be considered “a must” for every ISO 9001 auditor. This intensive course is specifically designed to train corporate staff to serve as internal ISO 9001 auditors (as required by ISO 9001:2015 ). The interactive training program, complete with quizzes, will provide the necessary technical knowledge and understanding of all ISO 9001:2015 requirements to perform a complete ISO 9001 audit.

ISO 30401 sets requirements and provides guidelines for establishing, implementing, maintaining, reviewing and improving an effective management system for knowledge management in organizations. All the requirements of this standard are applicable to any organization, regardless of its type or size, or the products and services it provides. Knowledge management is the intentional process of defining, structuring, retaining, and sharing an organization’s employees’ knowledge and experience.

The “ISO 30414:2018 Lead Auditor” course provides comprehensive training for participants to be able to: Understand to audit each and every ISO 30414:2018 guidelines; Identify measurement opportunities; diagnose HR financial and operational measures, Quantify HR department’s contribution to the overall bottom line, through solid, factual, and verifiable data and analyze toughest workforce decisions with easy-to-use mathematical formulas. Learn fundamental auditing skills;

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 fundamental tool to identify waste, create effective process flow, reduce process cycle times, and implement process improvement.

The “ISO 27001: 2013 Lead Auditor” course provides comprehensive training in the ISO 27001: 2013 standard and all its requirements from the Lead auditor’s point of view, as well as basic skills necessary to Lead audit activities. It’s a practical-oriented training that should be considered “a must” for every ISO 27001: 2013 Lead auditor.

All organizations have policies and procedures that guide how decisions are made and how the work is done in that organization. Professionally written policies and procedures increase organizational accountability and transparency and are fundamental to quality/standards assurance and quality improvement.

The “ISO 17025:2018 Lead Assessor” course provides comprehensive training in Learn how to audit each and every ISO 17025: 2018 and ISO 17011 requirements Learn basic auditing skills; Implement methods to comply with the ISO 17025:2018 requirements. Auditing process and techniques

This very practical one-day IACCM-approved programme enables participants to manage the process of commercial contracting and contract management effectively and efficiently to ensure value for money, improved service, and appropriate relationships. It covers a wide range of contract types in terms of risk and value. The programme empowers participants with the tools and techniques needed to collaborate with all key stakeholders. By the end of the programme participants will be able to: * Understand the total process of managing contracts * Exploit opportunities to extract even more added value * Develop appropriate relationships with contractors * Understand and use a range of contracting strategies and options * Measure and improve contract performance * Understand the impact of legislation on contract performance 1 WELCOME * Introductions * Aims and objectives * Plan for the day 2 CONTRACT MANAGEMENT * An overview of the contracting process, mapping the 'territory' 3 CONTRACT MANAGERS * Skills * Knowledge * Attributes * Responsibilities 4 CRITICAL SUCCESS FACTORS * Defining successful outcomes * Effective stakeholder engagement * Creating a shared vision of the outcomes 5 PLACING CONTRACTS * How to develop an effective specification and scope of work documents * How to develop a robust contracting strategy * Appropriate types of contract 6 CUSTOMERS AND STAKEHOLDERS * Customer and stakeholder analysis * Managing expectations and the 'shared vision' concept to ensure customer co-operation, satisfaction, and delight 7 WORKING WITH SUPPLIERS * Creating and developing commercial relationships * Types of relationship * How to manage difficult relationships * Contractor motivational issues * How to use incentives 8 NEGOTIATION AND RELATED SKILLS * Introduction to key negotiation skills * Persuading and influencing skills to work with stakeholders to improve outcomes for all 9 DEALING WITH CHANGE * Claims and variations * How to challenge contractor claims and requests for variations by making use of contractual terms * Specifications to prevent false claims 10 PERFORMANCE IMPROVEMENT * How to measure and improve contractor performance * Developing KPI systems * Using contractual terms and conditions and basic legal principles 11 CONTRACT CLOSE * The importance of effective contract close processes 12 CLOSE * Review of key learning points * Personal action planning