GCP Regulatory Inspections

You have completed the observation and recording phase of your audit. You have gathered all your evidence. How are you going to communicate your findings and conclusions? Will things change as a result? This course will explore principles and best practice in the analysis and reporting of audit findings through informative presentations and practical exercises.

This is an advanced skills course, which will focus on improving the auditor’s performance during audit preparation and conduct, including tips and new strategies to try. Delegates will be expected to reflect on and share their own previous experiences. This course has the option of Audit Clinics where delegates may request a 1-1 session with a course tutor for advice on any aspect of the audit process.

This course is an extension to the course 'An Introduction to Good Laboratory Practice' based on the principles of Good Laboratory Practice as published by the OECD. It takes a broader look at topics such as multi-site studies and computerised systems. The course is divided into five bite size modules, The Good Laboratory Practice Quality System, Multi-site Study Operations, Multi-site Study Performance, Multi-site Quality Assurance, Computerised systems. Each bite-size learning module is around 30 minutes in duration and includes self-assessment to confirm your gained knowledge.

This online course provides an introduction to Quality Risk Management and is divided into the following eight bite size learning Modules, What is Quality Risk Management, Understanding the Quality Risk Management Principles and Process, Corporate Governance, Risk Assessment, Risk Assessment Methodologies, Risk Control, Risk Review and Communication, Quality Risk Management Implementation.

This online course provides an introduction to risk-based quality systems and is made up of the following seven bite size learning Modules, Risk-Based Approach to Quality Management, Demand for Risk-Based Quality Systems, Robust Quality System Models, ICH Q8, Q9 and Q10, Development and Implementation, Core Elements, Quality Systems and Regulatory Inspections.

The course will work through why audits are important and understanding the drivers behind a good audit programme. It will discuss how to identify and assess the risks in your organisation, linking them with organisational goals, using these risks as a basis for the design of a risk based audit programme during facilitated practical workshops. Delegates will have the opportunity to consider and discuss common issues and constraints that may shape their audit programmes.

This course will equip you with the basic analytical skills and knowledge you need to interpret and use data effectively.

This course is designed to provide comprehensive guidance and practical help for those who fulfil the role of Study Director or Principal Investigator in the conduct of non-clinical safety studies on pharmaceuticals, agricultural and industrial chemicals in compliance with Good Laboratory Practice. This course will also be of considerable benefit to study staff and management working in a GLP environment. The course will address current OECD GLP Principles and UK GLP legislation, but will also make reference to other international standards, regulations and guidelines.

The course is aimed at providing a reminder and refresh insight of the key GLP requirements and responsibilities and also to look at recent hot topics and trends. Specific areas covered include Data Integrity, Risk Assessment and the new OECD guidance on Test items. The programme also includes a GLP clinic where delegates can identify any relevant topics for discussion. The course is aimed at Study Directors, Principal Investigators, Test Facility Management and QA.

In this course participants will discover what the GCP Inspectors "Hot Topics" are that have been added to E6 R2, whether these match with other major developments in GCP and if the regulation will have an impact on their organisation.

This course is designed to provide comprehensive guidance and practical help for those who are implementing Good Clinical Laboratory Practice in laboratories which undertake the analysis of samples from clinical trials. The course will address the current regulatory framework for laboratory work in support of clinical trials with reference to the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive and related regulations and guidance. The course will also draw on the RQA guidance document on Good Clinical Laboratory Practice (GCLP).

This two day course is the ideal external training opportunity for people needing to gain a basic understanding of computerised system validation. The knowledge gained will help attendees to validate systems within their own organisation for use in GxP (GLP, GCP, GMP, GDP and GPvP) environments, and to audit validated computerised systems to assure compliance with the applicable GxP regulations.

Often the first steps of implementing a quality system are the most difficult and this eLearning course provides vital guidance on how to set about implementing GCLP within your own laboratory. The training will also be beneficial to those who work within a clinical trials laboratory and who need to understand the GCLP requirements and comply with GCP regulations. The course provides step-by-step guidance, in modular form, on all the major system and process requirements for GCLP compliance. It is an invaluable tool for implementing and maintaining the GCLP quality system.

This interactive online web-based course introduces Good Clinical Practice. The course is divided into the following six bite-size learning Modules, The History of Good Clinical Practice, ICH GCP Guidelines - History and Introduction, Protocol, Sponsor Responsibilities and Essential Documents, Investigator Brochure, Ethics Committees and Investigator Responsibilities, European Union Clinical Trial Directives, Declaration of Helsinki.

This course introduces Good Laboratory Practice. The course is divided into the following seven bite-size learning Modules, The Good Laboratory Practice Quality System, The Good Laboratory Practice Test Facility, Test Facility Responsibilities, National Compliance Monitoring, The Good Laboratory Practice Study, Study Performance, Study Completion. Each bite-size learning module is around 30 minutes in duration and includes self-assessment to confirm your gained knowledge.

The course is divided into the following modules, The GLP Study Director in Single Site Studies, The GLP Study Director in Multi-Site Studies, Study Initiation, Study Performance, Study Completion, Study Communication, Test Facility Roles and Responsibilities, Regulatory Inspections.

This online course introduces Good Manufacturing Practice for Investigational Medicinal Products. It is divided into the following ten bite-size learning Modules, Events leading to the introduction of Good Manufacturing Practice, The evolution of Good Manufacturing Practices, Regulations around the world, Understanding the basic principles of Good Manufacturing Practice within a research & development context, Overview of the EU Good Manufacturing Practices (Part 1), Overview of the EU Good Manufacturing Practices (Part 2), The EU Good Manufacturing Practice annexes, Annex 13, Investigational Medicinal Products, The role of the Qualified Person, Additional resources.

This course is designed to provide comprehensive guidance and practical help for those working to implement Good Manufacturing Practice. Scope, Basic requirements for a pharmaceutical quality system (PQS) and an understanding of quality risk management (QRM) principles and their application, from current regulations and guidance. An introduction to the Site Master File, roles and responsibilities, change control, document control, and key documentation for implementing Good Manufacturing Practice (GMP) with regulatory inspection in mind. Common regulatory findings.

Lean principles have come a long way over the past 300 years. From Benjamin Franklin's early ideas, to Henry Ford's work in the 1920's and the Toyoda precepts in the 1930's, to Jeffery Liker's publication of The Toyota Way in 2004, Lean processes have evolved from a simple concept to a set of widely used best practices. This course will give participants the foundation to begin implementing Lean process improvement tools in their workplace. You will explore the foundations of Lean through the Toyota precepts and the five critical improvement concepts (value, waste, variation, complexity, and continuous improvement).

This online course covers the background and the granting of authority to managing an audit programme together with its establishment, implementation, monitoring and reviewing and finally opportunities on how to improve an audit programme. The course is made up of the following six bite-size learning Modules, General Introduction, Granting of Authority, Establishing the Audit Programme, Implementing the audit programme, Monitoring and Review, Improvement.

The course is made up of nine learning modules and is intended to introduce the audit process and includes, An understanding of the aims of the audit, Identifying how to initiate the audit, An understanding of how to effectively conduct document review, Preparation for on-site audit activities, How to perform on-site audit activities, An appreciation of the requirements of preparing, approving and distributing the audit report, How to complete an audit and conducting audit follow up, Identifying trends, performing root cause analysis and considering corrective and preventive action.

This online course introduces the UK Clinical Trials Regulations (UKSI 2004 No 1031 and UKSI 2006 No 1928). The course is divided into the following seven bite size learning Modules Good Clinical Practice and UK Law, Good Clinical Practice legal texts in and outside, ICH Good Clinical Practice and the UKSIs - How do they compare? What do the UKSIs require of us? Pharmacovigilance, The UKSIs and investigational medicinal products, Finding your way around the UKSIs.

Following its adoption on the 30th September 2018, this eLearning module looks at the changes and nuances between 9001,2008, and 9001,2015. This course has 7 modules, and includes videos and delegate led interactions.

This well established course will explore key phases of process and system auditing. It will provide guidance on auditing systems and processes at both the global and local organisational level. 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 well-established course will explore key phases of pharmacovigilance auditing. It will address the impact of the EU pharmacovigilance legislation on auditing and provide guidance on auditing pharmacovigilance systems at both the global and local organisational level. This course is designed for pharmacovigilance auditors, auditors new to pharmacovigilance and pharmacovigilance professionals to provide them with insight into developing and/or optimising a pharmacovigilance audit programme. In order to gain maximum benefit from the course, an understanding of pharmacovigilance is advantageous.

We make decisions and solve problems continually. We start making decisions before we even get out of bed (shall I get up now or not?). Sometimes, we will have made as many as 50 decisions by the time we leave for work. Despite all the natural decision making that goes on and the problem solving we do, some people are very uncomfortable with having to make decisions. You have probably looked at a solution to something and said, "I could have thought of that." The key to finding creative solutions is not just creativity, although that will certainly help. The answer rests in our ability to identify options, research them, and then put things together in a way that works. Having a process to work through can take the anxiety out of problem solving and make decisions easier.

Quality means different things to different people, but central to all definitions is that quality is about meeting a standard. One definition states that quality is 'the degree to which a set of inherent properties of a product, system or process fulfill requirement'. The standards or requirements involved will be defined by circumstance. What does need to be clear is what the standard is. Measuring and demonstrating whether the work is up to the standard is part of Quality Assurance.

A quality system in your research laboratory is the most effective and efficient way to, help scientists work more efficiently, ensure discoveries can be defended, protect the value of intellectual property. This highly interactive course will provide guidance on why and how to implement a quality system successfully into the research laboratory. By doing so, you will position your innovation for the success that it deserves. But leave things as they are and there is a good chance that your science will not realise its full potential should success, and its consequences, come your way.

This course offers the ideal external training opportunity for those starting out as Quality Assurance auditors or working under Good Laboratory Practice regulation for the first time.

The purpose of this course is to facilitate how delegates visualise, monitor and provide assurance of how elements of the pharmacovigilance system fit together, interact and change over time to achieve the objectives of pharmacovigilance. Auditors and Pharmacovigilance (PV) practitioners will explore application of the legal requirements in the GVP modules. They will examine how the PV system and its quality system interact to achieve compliance with regulatory requirements. PV auditors will develop an approach to define the scope of the PV audit and conduct PV audits. Practitioners will develop an approach to implementing, monitoring and maintaining the PV system.

This course is specifically designed to develop and refine personal skills in the planning, performance and reporting of audits. It is applicable to any area of regulated research and development. It is particularly valuable where there is a quality system requirement for audit. In order to gain maximum benefit from the course it is recommended that participants have personal experience of audit.

VICH GL9 (GCP) is an international guidance document that was issued in 2000, with the expectation that all veterinary clinical studies initiated after 2001 would follow the guidance. This course provides an introduction into the requirements of VICH GCP as applied to the conduct of veterinary clinical studies. It covers the key roles and responsibilities of the Sponsor, Monitor, Investigator and Quality Assurance. The design and planning, the conduct and the subsequent reporting of clinical studies is described, together with guidance on the recording of data. The content is a reflection of guideline requirements together with some suggestions for best practice.