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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

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Emotional Intelligence Training

These topics are available as individual sessions or we can deliver all three as a full day’s training for Registered Practitioners. Facilitated by registered clinicians with extensive experience.

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.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

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

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.