Good Laboratory Practice (GLP) courses in Cardiff

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.  

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 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 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

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