894 Quality Assurance (QA) courses

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 “ISO 42001:2023 Lead Implementer Course” is designed to provide participants with the knowledge and skills necessary to lead the implementation of an Artificial Intelligence Management System based on ISO 42001:2023. This comprehensive course covers the key principles, requirements, and best practices for establishing and maintaining an effective Artificial Intelligence management system. Participants will learn how to develop, implement, and manage processes that comply with the ISO 42001 standard.

Project Quality Management In today's environment, quality is the responsibility of everyone. Project success is no longer just the fulfillment of a project on schedule, on budget, and within the scope. Today, projects aren't successful unless the customer's needs are met at the highest level of quality at the lowest cost to the organization. Project Managers must know customer needs, and manage to them throughout the project lifecycle, in order to gain acceptance. Project Quality Management provides an interactive, hands-on environment for participants to practice identification of critical quality requirements (quality planning), fulfillment of those requirements through well-designed processes (Quality Assurance), and statistical awareness of technical specifications of project deliverables (Quality Control). What You Will Learn You'll learn how to: Plan for higher quality project deliverables Measure key performance indicators on projects, processes, and products Turn data into useful project information Take action on analyzed data that will drive down non-value-added costs and drive up customer acceptance and satisfaction Reduce defects and waste in current project management processes Foundation Concepts Quality Defined Customer Focus Financial Focus Quality Management Process Management Cost of Quality Planning for Quality Project Manager Role in Planning Voice of the Customer Quality Management Plan Measurement System Accuracy Data Gathering Data Sampling Manage Quality Process Management Process Mapping Process Analysis Value Stream Mapping Standardization Visual Workplace and 5S Error Proofing (Poka-Yoke) Failure Mode and Effect Analysis Control Quality The Concept of Variation Common Cause Special Cause Standard Business Reports Tracking Key Measurements Control Charts Data Analysis Variation Root Cause Analysis Variance Management Designing for Quality

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Project Quality Management: In-House Training In today's environment, quality is the responsibility of everyone. Project success is no longer just the fulfillment of a project on schedule, on budget, and within the scope. Today, projects aren't successful unless the customer's needs are met at the highest level of quality at the lowest cost to the organization. Project Managers must know customer needs, and manage to them throughout the project lifecycle, in order to gain acceptance. Project Quality Management provides an interactive, hands-on environment for participants to practice identification of critical quality requirements (quality planning), fulfillment of those requirements through well-designed processes (Quality Assurance), and statistical awareness of technical specifications of project deliverables (Quality Control). What You Will Learn You'll learn how to: Plan for higher quality project deliverables Measure key performance indicators on projects, processes, and products Turn data into useful project information Take action on analyzed data that will drive down non-value-added costs and drive up customer acceptance and satisfaction Reduce defects and waste in current project management processes Foundation Concepts Quality Defined Customer Focus Financial Focus Quality Management Process Management Cost of Quality Planning for Quality Project Manager Role in Planning Voice of the Customer Quality Management Plan Measurement System Accuracy Data Gathering Data Sampling Manage Quality Process Management Process Mapping Process Analysis Value Stream Mapping Standardization Visual Workplace and 5S Error Proofing (Poka-Yoke) Failure Mode and Effect Analysis Control Quality The Concept of Variation Common Cause Special Cause Standard Business Reports Tracking Key Measurements Control Charts Data Analysis Variation Root Cause Analysis Variance Management Designing for Quality

The course price includes Refreshments, Car Parking Fees, Workbooks, Resources including access to our Trainer Resource Pack via the Approved Trainer HUB, Approved Trainer Membership, Approved Trainer T-Shirt, Ongoing Quality Assurance , support and Certification. We deliver this course to small groups a maximum of 4 people attend this course at our training premises ensuring all our learners receive Quality time with the Trainers/ Assessors delivering the course.

Take our part-time online “Conversion Course into Pharmaceutical Manufacturing“ NO Previous Industry Experience or Science Qualifications Required

Course Information Designed to develop personal proficiency in audit planning, execution and reporting, this course is meticulously crafted to refine essential audit skill sets. Through immersive scenarios focused on on-site audit conduct (with an alternative Remote Auditing Course available), participants will engage deeply in the audit process. Extending Expertise: Applicable across all audit types, this course builds upon and enriches the foundational concepts taught in RQA's suite of research quality assurance courses. From 'Research Quality Assurance for Good Laboratory Practice' to 'Good Clinical Practice Auditing – Principles and Practice' and 'Good Manufacturing Practice for Investigational Medicinal Products,' this programme extends the scope of learning. Relevance and Value: Relevant to any area of regulated research and development, this course shines particularly in contexts mandating a quality system for audit. Participants with prior audit experience will gain maximum value from this course.  Key Benefits: Enrich your skill set to: Navigate audit processes encompassing planning, execution, reporting, and follow-up Embrace a personalised approach fostering positive audit outcomes Analyse evidence and present cohesive audit findings Recognise the pivotal role of audits in driving continual improvement. Interactive Learning: Structured to foster dynamic engagement, this course encourages delegates to: Engage in discussions, idea development, and problem-solving Exchange invaluable information and experiences. Hands-On Experience: A highlight of this course is the series of practical workshops, where delegates work in small syndicate groups, applying the acquired skills from lectures into real-world scenarios. Tutors Tutors will be comprised of (click the photos for biographies): Andrew Waddell Founder Director, Tower Mains Ltd Rosemary Ichaba Senior QA Associate, Tower Mains Ltd Cate Ovington Director, The Knowlogy Group Ltd Jean McWilliam Associate Director, Alexion View pop up Programme Please note timings may be subject to alteration. Day 1 08:45 Registration 09:00 Welcome and Course Objectives 09:10 What is 'Audit'? Delegates explore the range of audits which they have experienced, define the purpose of each audit type and establish which of those audits are performed to meet regulatory requirements. 09:30 Audits and their Purpose The concepts of quality assurance, quality control, quality management and audit are discussed. 10:30 Break 10:45 Audit Planning The requirements for an effective audit programme and individual audit plans. 11:30 Workshop 1 - Getting the Audit Started Planning for the audit. 12:25 Workshop 1 - Feedback 12:45 Lunch 13:30 Workshop 2 - Getting the Audit Started Arranging the opening meeting. 13:50 Workshop 2 - Feedback Audit initiation. Review and discussion of the role of the opening meeting. 14:25 Auditing Techniques (1) - Data and Documentation Techniques for the conduct of data and report audits are investigated. 14:55 Break 15:10 Workshop 3 - Data and Documentation Audit Conducting an audit of a data package and supporting documentation. 17:15 Close of Day Day 2 09:00 Auditing Techniques (2) - The People Questioning techniques which get the required information from the auditee. 09:45 Live Audit Role Play Auditor and auditee behaviours are explored and strategies developed for successful audit interactions. 10:15 Break 10:35 Audit Closing Meeting An exploration of audit closing meetings. 11:00 Workshop 4 - Audit Observations and Preparing for the Closing Meeting Reviewing and categorising your observations and getting ready to present your case. 11:45 Workshop 4 - Feedback 12:30 Audit Reports The content and distribution of an effective audit report are investigated and the importance of effective written communication is discussed. 13:00 Lunch 13:45 Workshop 5 - Audit Reports and Follow-up Mechanisms for promoting effective corrective and preventive action. Critical review of an audit report example. 14:30 Workshop 5 - Feedback 14:55 Corrective and Preventive Action and Follow-up The auditor's role in monitoring responses to audit and the corrective and preventive actions promised is explored. 15:20 Panel Session An opportunity to get answers to outstanding questions. 15:30 Close of Course Extra Information 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. CPD Points 14 Points   Development Level Develop

Course Information Embark on our GLP course offering extensive guidance and pragmatic support tailored for individuals serving as Study Directors or Principal Investigators overseeing non-clinical safety studies on pharmaceuticals, agricultural, and industrial chemicals within the realm of Good Laboratory Practice (GLP). This comprehensive programme extends its benefits to study staff and management operating in GLP-compliant environments. The course extensively covers the current OECD GLP Principles and UK GLP legislation, while also referencing international standards, regulations, and guidelines pertinent to the field. Benefits of this course: Practical help and guidance on the interpretation and application of GLP An opportunity to update your knowledge of GLP with the current interpretation of requirements Access to an experienced panel of speakers Information on how other organisations address GLP issues An opportunity to improve your understanding of the GLP requirements as they are applied in different situations. This course is structured to encourage delegates to: Discuss and develop ideas Solve specific problems Examine particular aspects of GLP Learn from the experience of others. Tutors Tutors will be comprised of (click the photos for biographies): Tim Stiles Consultant, Qualogy Ltd Tony Woodall Head of Quality Assurance, Alderley Analytical Gill Armour Study Monitor Team Leader, AstraZeneca Jane Elliston Senior Quality Assurance Auditor, Battelle UK Vanessa Grant -, - Jeanet Logsted CEO, Scantox Programme Please note timings may be subject to alteration. Day 1 09:00 Registration 09:15 Welcome and Introductions 09:35 Development of Good Laboratory Practice A review of the history of GLP, its current scope and application, with a synopsis of current European and international standards. 10:05 Roles and Responsibilities The responsibilities of study director, test facility, management and study staff in the conduct of a GLP study. 10:45 Break 11:00 The Roles and Responsibilities of the Study Director and Test Facility Management The role of the study director in the management and control of a study, as defined by GLP, and management's roles are explored. 11:45 Multi-site Studies What is a multi-site study and when should such concepts be applied on a study. The role of the study director and principal investigator in the planning, conduct and reporting of multi-site study are explored. 12:30 Study Plan (Protocols) GLP requirements for the preparation of a study plan, content, authorisation, amendments and deviations are discussed. 13:00 Lunch 13:45 Workshop 1 - The Study Plan Some practical problems with study plans and amendments explored. 14:45 Workshop 1 - Feedback 15:00 Standard Operating Procedures The control, content and authorisation of SOPs and the principles behind the practice. 15:30 Break 15:45 Workshop 2 - Practical Study Conduct Problems Dealing with practical problems encountered during the conduct of studies. 16:40 Workshop 2 - Feedback 17:15 Close of Day Day 2 09:00 Questions and Answers Discussion of issues raised by course delegates. 09:20 Quality Assurance The interactions between QA, management, study director and principal Investigator are discussed as is QAs role when conducting a multi-site study. 10:00 The Final Report The content of the final report and the role of those involved in its preparation and approval. Specific reporting requirements when conducting a multi-site study are also explained. 10:30 Break 10:45 Workshop 3 - Final Report Problems Practical problems of report preparation including compliance statements. 11:30 Workshop 3 - Feedback 12:00 Management of Raw Data and Records A view on how records and materials are managed and archived in compliance with GLP. 12:45 Lunch 13:30 Workshop 4 - Data and Sample Management Issues Dealing with data and sample management issues. 14:15 Workshop 4 - Feedback 14:45 Regulatory Inspection Government monitoring for compliance with Good Laboratory Practice. 15:15 Panel Session This panel session will address any outstanding issues raised by delegates. 15:45 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

About this Virtual Instructor Led Training (VILT)  Accredited by the United Kingdom Lubricants Association (UKLA), this 4 half-day Virtual Instructor Led Training (VILT) course will provide an in-depth understanding of the principles, economics and flexibility of lubricant blending plants and how to operate a lubricants blending plant efficiently and economically. The latest developments and trends in lubricant blending and the advantages and disadvantages of lubricant blending equipment, facilities and operations will be discussed. The importance of testing components and products for each blend, lubricant blend quality control and product quality management will also be explained. The VILT course will also clarify the importance of lubricant product filling, packaging and warehouse storage, strategies for optimising existing lubricant blending plant facilities and how to avoid or minimise problems with lubricant blending and product quality. The VILT course is recognised under the UKLA Continuing Professional Development (CPD) scheme for Registered Lubricant Professional. *There will be an examination for this VILT.   Training Objectives This VILT course will enable you to: Learn about Mineral Oil Base Oils; API Groups I, II and III: Properties and Characteristics Acquire the knowledge about Synthetic Base Oils; API Groups IV and V: Properties and Characteristics Learn about Lubricant Additives: Properties and Characteristics Know the Lubricant Formulation and Ease of Blending Explore the Blending Plant Design: Grassroots Plants and Upgrading Existing Plants Learn about Blending Plant Equipment and Facilities and Their Operation Understand the Lubricant Blending Issues: Avoiding Problems Test and Analyse Base Oils and Additives Test and Analyse Blended Lubricants Explore the importance of Product Quality Control Understand the process of Lubricant Packaging and Filling Understand the process of Lubricant Storage Learn about Product Quality Management Target Audience This VILT course will be useful and applicable for: Middle and Senior managers to understand how and why to design and operate an efficient and profitable lubricant blending plant. Blending plant operators and specialists to improve and optimise current blending plant operations. Manufacturers of lubricants will understand how and why high quality components and effective testing during the entire blending process are important to final lubricant product quality and performance. Lubricant formulators will understand the importance of close communication and co-operation with blending plant managers and operators to minimise blending costs and to thereby maximise product profitability. Course Level Intermediate 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. Course Duration: 4 half-day sessions, 4 hours per session (16 hours in total). Trainer Your expert course leader (CChem, MRC) has worked as Sales, Technical Marketing Manager and Company Director with over 50 years of broad experience in the lubricants, fuels, petroleum additives, with four leading companies Chevron, Ethyl Petroleum Additives Ltd, Texaco Limited and Kuwait Petroleum (GB) Ltd. His major recent responsibilities have been concerned with leading the Oil Industry Association United Kingdom Lubricants Association, and acting in an advisory capacity as Technical Director to the Association. He has acquired a wide experience in technical, marketing and sales within the oil industry. The related experience gained with the oil additives industry has provided him with special additional insights. He has also led the Certificate of Lubricant Competence course for the United Kingdom Lubricants Association (UKLA) for 11 years. He is a Chartered Chemist and a Member of the Royal Society of Chemistry. 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