Good Laboratory Practice (GLP) courses in Manchester

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

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.  

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