21 Good Laboratory Practice (GLP) courses

This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).

This short entry-level module introduces the learner to good practices (GxP) in drug development and manufacturing. It outlines how the industry operates and how it is regulated. It identifies regulatory authorities and other important sources of guidance on Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), and Good Laboratory Practice (GLP).

Course Information Join us for a comprehensive refresher focusing on crucial Good Laboratory Practice (GLP) requirements, including an emphasis on data integrity, recent developments, and emerging trends gleaned from MHRA inspections. The programme dives into specific domains such as risk assessment, OECD guidance on sponsor influence, and the advisory from OECD on QA. Additionally, delegates can benefit from a dedicated GLP clinic, facilitating discussions on understanding and upholding GLP compliance. Is this course for you? This course is tailored for study directors, principal investigators, test facility management, and QA professionals seeking to refresh their knowledge and responsibilities within the GLP framework. Tutors Tutors will be comprised of (click the photos for biographies): Vanessa Grant -, - Tim Stiles Consultant, Qualogy Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Registration, Welcome and Introduction 09:20 Development of Good Laboratory Practice A reminder of the history of GLP, its current scope and application, with a synopsis of current UK, European and international standards. 09:50 Roles and Responsibilities of Study Director, Test Facility Management, Principal Investigator, Test Site Management, Study Staff and QA A reminder of the roles and responsibilities with regard to the GLP management and oversight of the Test Facility and the management and control of the study, as defined by GLP. 10:30 Break 10:45 Workshop 1 Workshop 1 Roles and responsibilities 11:15 Influence of Sponsors The published OECD Position Paper No. 21 regarding Possible Influence of Sponsors on conclusions of GLP Studies is reviewed and discussed. 11:45 Data Integrity The fundamentals of data integrity according to the OECD Guidance No. 22 on Data Integrity is discussed along with the responsibilities of Study Director, Test Facility Management, and study staff in ensuring the integrity of the GLP study data. 12:30 Lunch 13:15 Quality Assurance and GLP OECD Advisory No. 23 (Revision of OECD No.4)- A walk through of the changes to the OECD Guidance on the role and activities of Quality Assurance 13:45 Quality Improvement Tools and GLP The tools that might be considered for GLP and their role and operation when used in Test Facilities- OECD Position Paper No.24 published July 2022 14:15 Workshop 2 Workshop 2 Change control 14:30 Risk Assessment How should we assess risk and how can we use the process to assist in evaluation audit findings? 15:00 Break 15:15 Current hot topics in GLP Explore the current issues in Industry and trends /types of Regulatory inspection findings 15:50 GLP Clinic An opportunity to discuss any other issues regarding understanding and maintaining GLP Compliance. 16:30 Close of Course Extra Information 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 7 Points   Development Level Learn

Course Information A must-have programme for Quality Assurance auditors stepping into or honing their role within a Good Laboratory Practice (GLP) environment, this course offers invaluable, expert guidance for crafting a robust and efficient GLP audit programme. What will I learn? A solid regulatory foundation underpinning quality assurance activities Clarity on the roles of Quality Assurance, management, and study director within the framework of Good Laboratory Practice principles Enhanced efficacy in inspections and audits Heightened compliance with Good Laboratory Practice standards for your facility Unique insights into governmental monitoring activities within the GLP sphere. This course is structured to encourage delegates to Discuss and develop ideas Solve specific problems Examine particular aspects of GLP. Tutors Tutors will be comprised of (click the photos for biographies): Cate Ovington Director, The Knowlogy Group Ltd Jane Elliston Senior Quality Assurance Auditor, Battelle UK Shona Ross Head of QA, Tower Mains Ltd Programme Please note timings may be subject to alteration. Day 1 09:00 Welcome and Introductions 09:15 Good Laboratory Practice Standards and Regulations An insight into the background and history of Good Laboratory Practice. 09:45 Principles of Quality Assurance What is the role and responsibilities of QA in GLP. Maintaining the independence of QA and what is an audit. 10:30 Break 10:45 Standard Operating Procedures GLP requirements and QA involvement. 11:30 Study Plans GLP requirements and QA involvement. 12:05 QA Programme Risk based programme, what are study, process and facility audits. 13:00 Lunch 14:00 Inspections Attitudes, techniques and attributes. 14:40 Workshop 1 - Facility and Process Inspections An exercise in inspection planning and preparation for inspections. 15:15 Break 15:30 Workshop 1 - Feedback 15:45 The Auditor and Audit Conduct Attitudes, attributes and techniques. 16:30 Panel Session An opportunity for delegates to put questions to the panel of speakers. 17:15 Close of Day Day 2 09:00 Workshop 2 - A Mock Audit 10:45 Break 11:00 Workshop 2 - Feedback 11:30 Auditing the Study Report Techniques and methods for the QA audit of the study report. 12:00 Record Keeping and Data The impact of GLP on data and records management. 12:40 Lunch 13:25 Data Integrity A look at the OECD GLP guidance document; the expectations of the regulators and the involvement of QA - Where QA adds value. 14:15 Workshop 3 - Amendments to Study Plan and Deviations from the Plan What are they? What is the difference between them? How are they controlled? 15:00 Workshop 3 - Feedback 15:15 Break 15:30 Regulatory Compliance GLP Monitoring Authority monitoring for compliance with Good Laboratory Practice. 16:15 Panel Session An opportunity for delegates to put questions to the panel of speakers. 16:45 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 Learn

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

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

The purpose of GLP is to provide assurance of the quality and reliability of nonclinical study data. GLP covers the planning, performance, monitoring, recording and reporting of studies. Regulatory authorities typically require GLP rules to be followed for nonclinical studies intended to support an application for approval of clinical research or marketing of a product containing the test item. This course outlines the history of GLP and explains why it is important, identifies the penalties that may be incurred for noncompliance, and sets out requirements that need to be met. Learners are also referred to the two main sources of GLP rules: The Organisation for Economic Co-operation and Development’s Principles on Good Laboratory Practice and US Regulation 21 CFR 58: Good Laboratory Practice for Nonclinical Laboratory Studies.

Course Information Join us for a two-day immersive course crafted to equip participants with an in-depth understanding of remote audit methodologies. Delve into the nuances between remote and face-to-face audits, dissecting their respective strengths and limitations. Through practical scenarios tailored for remote audit conduct, this course stands as an essential counterpart to our on-site audits course The Auditing Course. Who Should Attend: Applicable across various domains of regulated research and development, this course proves invaluable in contexts requiring a quality system for audit. Participants with firsthand audit experience stand to gain the most benefit from this programme. Expanding on Previous Learning: This course extends its relevance to all forms of audits and further amplifies concepts explored in RQA's suite of research quality assurance courses, including: 'Research Quality Assurance for Good Laboratory Practice,' 'Good Clinical Practice Auditing – Principles and Practice,' and 'Good Manufacturing Practice for Investigational Medicinal Products.' Benefits include improved: Understand the processes of planning, conducting, reporting and follow-up of audits Recognising the importance of personal approach in developing positive audit outcomes Ability to analyse evidence and present logical audit findings Appreciate the importance of audit in continuing improvement. This course is structured to encourage delegates to: Discuss and develop ideas Solve problems Exchange information. 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 Programme Please note timings may be subject to alteration. Day 1 09:00 Course Registration 09:15 Welcome and Introductions 09:35 Introduction to Audits 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. 10:05 Introduction to Remote Audits Presentation to introduce the major differences between face-to-face audits and remote audits. The major elements of audits will be examined to determine where there may be differences. 10:30 Break 10:45 Workshop 1 - Remote Audits This workshop will examine participants experience or understanding of the differences between face-to-face and remote audits. 11:15 Workshop 1 - Feedback 11:35 Audit Preparation The essential steps in preparation for audits will be discussed with emphasis on remote audits. 12:05 Workshop 2 - Remote Audit Preparation Factors relating to the preparation for remote audits will be considered in discussion groups. 12:35 Workshop 2 - Feedback 12:50 Lunch 13:30 Audit Logistics Preparation for the audit includes many arrangements other than the audit content. 14:00 Workshop 3 - Audit Logistics Delegates will discuss some of the issues that may occur during the set up and conduct of remote audits and how to resolve them. 14:30 Workshop 3 - Feedback 14:45 Break 15:00 The Opening Meeting Presentation regarding the importance and content of the opening meeting. 15:20 Workshop 4 - Opening Meeting Delegates will consider the practicalities of arranging and conducting an opening meeting. 15:45 Workshop 4 - Feedback 16:10 Audit Conduct Tools Practical advice on preparation of some of the tools that will be valuable in the conduct of audits. 16:40 Questions and Answers An overview of the first day and a chance to ask questions 17:00 Close of Day Day 2 09:00 Reflections on Day 1 Recap on the topics covered and a chance for delegates to raise points. 09:15 Gathering Evidence Presentation on challenges of gathering evidence and conducting interviews during remote audits. 09:45 Workshop 5 - Remote Interviews Scenarios of different remote interviews will be played and delegates assess the strengths and weaknesses of each approach. 10:15 Break 10:30 Creating Audit Findings Ideas regarding how to create good audit findings will be discussed during this short presentation. 10:50 Workshop 6 - Creating Audit Findings Delegates will be provided with examples of evidence from an audit. They will discuss these and create their audit findings for presentation at the closing meeting. 11:35 The Closing Meeting The content and conduct of the closing meeting will be discussed. 11:55 Workshop 7(a) - Preparing for the Closing Meeting The findings from workshop 6 will be reviewed and a Lead Auditor selected to provide feedback in workshop 7(b) 12:15 Workshop 7(b) - The Closing Meeting The Lead Auditor from each group will hold a meeting to present the results (role play). 12:45 Lunch 13:30 The Audit Report This presentation will cover not only the essential contents of the audit report but also how to write the report in a manner that will generate the most positive reaction. 14:00 Workshop 8 - The Audit Report Delegates will be provided with an audit report from an audit conducted remotely and will conduct a peer review of the report in their breakout groups. 15:00 Workshop 8 - Feedback 15:20 Break 15:35 Audit Closure Presentation on how to conclude the audit with reference to post-audit activities. 15:55 Open Forum 16:30 Close of Course Extra Information 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.  

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

Explore the intricacies of laboratory safety with our comprehensive course, 'Laboratory Safety: Protocols & Best Practices.' Gain expertise in risk assessment, PPE usage, chemical safety, fire and electrical safety, equipment handling, and fostering a safety culture. Elevate your understanding of best practices, ensuring a secure laboratory environment. Join us to empower yourself with the knowledge and skills to champion safety in the pursuit of groundbreaking research. Enroll now for a transformative learning experience!