9 Pharmaceutical courses delivered Live Online

CPD accredited Level 3 Effective Auditing & Inspection course. Delivered online (Zoom) by a live tutor. Exam and Certificate fee included in the price.

ICA ADVANCED CERTIFICATE IN BUSINESS COMPLIANCE The ICA Advanced Certificate in Business Compliance has been specifically designed for those working outside financial services. The need for guidance and training in meeting regulatory requirements extends to many industry sectors including oil and gas, aerospace, pharmaceuticals, telecoms, and manufacturing. This course will enable practitioners working in areas such as these to gain knowledge of the essentials of compliance in a practical business context as well as understand the roles of both the compliance function and compliance professionals. The Advanced Certificate will develop the compliance/risk management knowledge and skills of individuals and thereby help to enhance the overall reputation and performance of their firms. Benefits of studying with ICA: * Flexible learning solutions that are suited to you * Our learner-centric approach means that you will gain relevant practical and academic skills and knowledge that can be used in your current role * Improve your career options by undertaking a globally recognised qualification that hiring managers look for as part of their hiring criteria * Many students have stated that they have received a promotion and/or pay rise as a direct result of gaining their qualification * The qualifications ensure that you are enabled to develop strategies to help manage and prevent risk within your firm, thus making you an invaluable asset within the current climate Upon successful completion of this course, students will be awarded the ICA Advanced Certificate in Business Compliance and will be able to use the designation - Adv.Cert(Bus.Comp). This qualification is awarded in association with Alliance Manchester Business School, the University of Manchester. What will you learn? * The context of compliance and its origins * Building an effective control framework * The skills needed to be an effective compliance professional * Risk management, alert systems and investigations * Managing financial crime risk * Creating competitive advantage How will you be assessed? * Assessed by a one-hour, question-based exam and one research-based assignment

ABOUT THIS TRAINING COURSE Managing process hazards in the hydrocarbon and chemical processing industries is a critical function that requires relevant knowledge and skills due to the risks involved. The Advanced Process Safety Engineering course will discuss the interrelation of the various techniques of process safety for analysing, with a particular emphasis on engineering design aspects, as well as how to manage process hazards in a safe and effective way and how they can potentially be avoided. In this 3 full-day advanced level course, the expert course leader will provide participants with insights and examples from his career and experience to show how their learning should be applied in real-life situations. Feedback and questioning is highly encouraged. Reference material and reports can be provided to give more information on any particular topic of interest. Individual and group exercises, tutored exercises and video case studies will be provided throughout the course to underpin the key learning points. Training Objectives Upon completion of this course, participants will acquire in-depth knowledge of: * Risk management and 'As Low as Reasonably Practicable' (ALARP) principles. * Different aspects of process design that influence process safety. * Approach to 'inherently safer' design. * Defence in depth using 'layers of protection'. * Process for ensuring the technical integrity of safety-critical equipment. * Hazards associated with process materials. * Range of hazard identification and consequence modelling techniques. * Causes and mitigation of human error. * Reliability and availability of safety-critical protection equipment. * Role of engineered safety-critical equipment and systems. Target Audience This course is suitable for industry professionals who need to acquire a comprehensive understanding of process safety. This includes those who are required to make managerial decisions where process safety is a key consideration, those who are moving into process safety positions or those who wish to broaden their process safety knowledge within their existing discipline. It is particularly suited for anyone involved in the design, operation, modification or maintenance of a major hazard installation, and will demonstrate a substantial understanding of process safety for those engaged in Continuous Professional Development or aiming for Chartered Engineer status. This course will benefit professionals such as: * Operations and maintenance supervisors * Process, mechanical and chemical engineers and technicians * Design engineers, project engineers and HSE managers * Control, automation and instrumentation engineers Course Level * Advanced Trainer Your expert course leader has 50 years' experience in chemical and process safety engineering. His early career included 20 years in design and project engineering with various fine chemical and pharmaceutical companies where he designed chemical processes, specified plant equipment and selected materials for highly corrosive and toxic processes, often where textbook data was not available. This was followed by 10 years in offshore oil and gas design projects where he was responsible for setting up a Technical Safety group to change design safety practices in the aftermath of the 1988 Piper Alpha disaster. In recent years, he has been called upon to conduct various offshore and onshore incident investigations. His career has given him experience in project engineering, project management, process design and operations, safety engineering and risk management. He is a Fellow of the UK Institution of Chemical Engineers. He served on the Scottish Branch committee, and was elected chairman for a two-year term in 1991. He has also been chairman of the Safety and Reliability Society - North of Scotland Branch. He has delivered training courses in Process Hazard Analysis (HAZOP and HAZID), Process Safety Management, Hazard Awareness, Risk Assessment, Root Cause Analysis, Failure Modes & Effect Analysis and has lectured on Reliability Analysis to the M.Sc. course in Process Safety and Loss Prevention at Sheffield University. In addition to delivering training courses, he currently facilitates HAZOP / HAZID / LOPA studies and undertakes expert witness roles advising lawyers engaged in contractual disputes, usually involving the design or construction of chemical plants or Oil & Gas production facilities, or criminal prosecutions. 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 post training support and fees applicable Accreditions And Affliations

ABOUT THIS TRAINING COURSE Process Hazard Assessment using the HAZOP Technique is an intensely participative course that will both explain the key facets of the HAZOP technique as well as provide ample opportunities for participants to practice and become familiar with the technique using generic and real-life examples. HAZOP Team Leader Training is an intensely participative course that will develop participants already familiar with the HAZOP technique, the skills, knowledge and attributes of a HAZOP Team Leader. An in-depth syndicate exercise will provide the opportunity to lead a HAZOP team (consisting of other participants) and to be observed performing the role for constructive feedback. This 5 full-day course has been reviewed and approved by the Institution of Chemical Engineers (IChemE). IChemE is the global professional membership organisation for chemical, biochemical and process engineers and other professionals involved in the chemical, process and bioprocess industries. Their knowledge of professional standards, close involvement with industry, education and regulators, and their expertise as a leading global training provider, means they are uniquely positioned to independently assess and approve training courses and professional development programmes across the world. Training Objectives Process Hazard Assessment using the HAZOP Technique By the end of this course, participants will be able to: * Understand the basic HAZOP Technique * Fulfill roles as competent HAZOP Team Members * Understand the role of HAZOP in risk management * Understand how Hazard Identification can predict accidents and incidents * Understand how HAZOP complements other hazard identification tool HAZOP Team Leader Training By the end of this course, participants will be able to: * Understand the role of the HAZOP Team Leader * Practise the role in a classroom environment * Provide feedback to participants on their performance as HAZOP Team Leaders * Appreciate the leadership skills required as HAZOP Team Leader * Plan, organise, manage and successfully undertake a Hazard and Operability study Target Audience This course will benefit: * All key persons in the organisation, who by their discipline and/or position, are likely to be called on to initiate, participate or review a HAZOP study. * All who have responsibility for the management and supervision of process & safety including but not limited to Senior Management, Plant Managers, Process and Maintenance Engineers (all disciplines), Line Supervisors, Team Leaders, Safety Specialists, and Process Training Instructors. Course Level * Basic or Foundation Trainer Your expert course leader has 50 years' experience in chemical and process safety engineering. His early career included 20 years in design and project engineering with various fine chemical and pharmaceutical companies where he designed chemical processes, specified plant equipment and selected materials for highly corrosive and toxic processes, often where textbook data was not available. This was followed by 10 years in offshore oil and gas design projects where he was responsible for setting up a Technical Safety group to change design safety practices in the aftermath of the 1988 Piper Alpha disaster. In recent years, he has been called upon to conduct various offshore and onshore incident investigations. His career has given him experience in project engineering, project management, process design and operations, safety engineering and risk management. He is a Fellow of the UK Institution of Chemical Engineers. He served on the Scottish Branch committee, and was elected chairman for a two-year term in 1991. He has also been chairman of the Safety and Reliability Society - North of Scotland Branch. He has delivered training courses in Process Hazard Analysis (HAZOP and HAZID), Process Safety Management, Hazard Awareness, Risk Assessment, Root Cause Analysis, Failure Modes & Effect Analysis and has lectured on Reliability Analysis to the M.Sc. course in Process Safety and Loss Prevention at Sheffield University. In addition to delivering training courses, he currently facilitates HAZOP / HAZID / LOPA studies and undertakes expert witness roles advising lawyers engaged in contractual disputes, usually involving the design or construction of chemical plants or Oil & Gas production facilities, or criminal prosecutions. 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 post training support and fees applicable Accreditions And Affliations

ABOUT THIS TRAINING COURSE This 5 full-day course covers all the main elements of IChemE's Process Safety Competency framework: culture, knowledge and competence, engineering and design, human factors, systems and procedures, and assurance. Participants will achieve at least the second level of competence 'Basic Application', which is defined as 'Performs fundamental and routine tasks. Requires occasional supervision. Increased functional expertise and ability. Works with others.' This course examines the interrelation of the various techniques of process safety for analysing and managing process hazards in the hydrocarbon and chemical processing industries. There is a particular emphasis on engineering design aspects with extensive participation in individual and group exercises, tutored exercises and video case studies throughout the course to underpin key learning points. The learning is consolidated in a comprehensive case study and requires collaboration between members of each syndicate. This course has been reviewed and approved by the Institution of Chemical Engineers. IChemE is the global professional membership organisation for chemical, biochemical and process engineers and other professionals involved in the chemical, process and bioprocess industries. Their knowledge of professional standards, close involvement with industry, education and regulators, and their expertise as a leading global training provider, means they are uniquely positioned to independently assess and approve training courses and professional development programmes across the world. Training Objectives By the end of this course, participants will be able to: * Acquire the underpinning knowledge required to achieve process safety competency * Gain a comprehensive understanding of process safety management * Understand the concept of the safety life cycle of a process plant from conceptual design onwards including operation, maintenance and modification * Understand the hazard scenarios associated with a process plant * Understand how risks can be controlled by hardware and procedural measures * Identify and analyse hazard causes and consequences * Recognise when specialist analytical expertise is required * Generate effective and appropriate measures to reduce risks * Justify and communicate practical solutions to non-technical personnel * Explain the rationale for process safety measures to decision makers Target Audience This course is suitable for process industry professionals who need to acquire a comprehensive understanding of process safety management, those moving into process safety positions or those who wish to broaden their process safety knowledge within their existing discipline. It is particularly suited for anyone involved in the design, operation, modification or maintenance of a major hazard installation. This includes: * Supervisors, operators and maintainers in Oil & Gas, Petrochemical and Chemical industries, * process, mechanical and chemical engineers and technicians * Design engineers, project engineers and HSE managers * Control, automation and instrumentation engineers It will also demonstrate a substantial understanding of process safety for those engaged in Continuous Professional Development or aiming for the Chartered Engineer status. Course Level * Basic or Foundation Trainer Your expert course leader has 50 years' experience in chemical and process safety engineering. His early career included 20 years in design and project engineering with various fine chemical and pharmaceutical companies where he designed chemical processes, specified plant equipment and selected materials for highly corrosive and toxic processes, often where textbook data was not available. This was followed by 10 years in offshore oil and gas design projects where he was responsible for setting up a Technical Safety group to change design safety practices in the aftermath of the 1988 Piper Alpha disaster. In recent years, he has been called upon to conduct various offshore and onshore incident investigations. His career has given him experience in project engineering, project management, process design and operations, safety engineering and risk management. He is a Fellow of the UK Institution of Chemical Engineers. He served on the Scottish Branch committee, and was elected chairman for a two-year term in 1991. He has also been chairman of the Safety and Reliability Society - North of Scotland Branch. He has delivered training courses in Process Hazard Analysis (HAZOP and HAZID), Process Safety Management, Hazard Awareness, Risk Assessment, Root Cause Analysis, Failure Modes & Effect Analysis and has lectured on Reliability Analysis to the M.Sc. course in Process Safety and Loss Prevention at Sheffield University. In addition to delivering training courses, he currently facilitates HAZOP / HAZID / LOPA studies and undertakes expert witness roles advising lawyers engaged in contractual disputes, usually involving the design or construction of chemical plants or Oil & Gas production facilities, or criminal prosecutions. 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 post training support and fees applicable Accreditions And Affliations

ABOUT THIS TRAINING COURSE This 5 full-day course provide a comprehensive understanding of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, HART protocol, control valves, actuators, and smart technology. This course will focus on maximizing the efficiency, reliability, and longevity of these systems and equipment by providing an understanding of the characteristics, selection criteria, common problems and repair techniques, preventive and predictive maintenance. This course is a MUST for anyone who is involved in the selection, applications, or maintenance of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology because it covers how these systems and equipment operate, the latest maintenance techniques, and provides guidelines and rules that ensure their successful operation. In addition, this course will cover in detail the basic design, operating characteristics, specification, selection criteria, advanced fault detection techniques, critical components and all preventive and predictive maintenance methods in order to increase the reliability of these systems andequipment and reduce their operation and maintenance cost This course will provide the following information for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology: * Basic Design * Specification * Selection Criteria * Sizing Calculations * Enclosures and Sealing Arrangements * Codes and Standards * Common Operational Problems * All Diagnostics, Troubleshooting, Testing, and Maintenance Practical applications of smart instrumentation, SCADA, and Distributed Control Systems, control valves, actuators, etc in the following industries will be discussed in detail: * Chemical and petrochemical * Power generation * Pulp and paper * Aerospace * Water and sewage treatment * Electrical power grids * Environmental monitoring and control systems * Pharmaceutical plants Training Objectives * Equipment Operation: Gain a thorough understanding of the operating characteristics of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Equipment Diagnostics and Inspection: Learn in detail all the diagnostic techniques and inspections required of critical components of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Equipment Testing: Understand thoroughly all the tests required for the various types of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Equipment Maintenance and Troubleshooting: Determine all the maintenance and troubleshooting activities required to minimize the downtime and operating cost of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Equipment Repair and Refurbishment: Gain a detailed understanding of the various methods used to repair and refurbish modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Efficiency, Reliability, and Longevity: Learn the various methods used to maximize the efficiency, reliability, and longevity of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Equipment Sizing: Gain a detailed understanding of all the calculations and sizing techniques used for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Design Features: Understand all the design features that improve the efficiency and reliability of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Equipment Selection: Learn how to select modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology by using the performance characteristics and selection criteria that you will learn in this course * Equipment Enclosures and Sealing Methods Learn about the various types of enclosures and sealing arrangements used for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Equipment Commissioning: Understand all the commissioning requirements for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Equipment Codes and Standards: Learn all the codes and standards applicable for modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * Equipment Causes and Modes of Failure: Understand the causes and modes of failure of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology * System Design: Learn all the requirements for designing different types of modern control systems, digital control, distributed control systems (DCSs), supervisory control and data acquisition (SCADA) systems, industrial instrumentation, control valves, actuators, and smart technology Target Audience * Engineers of all disciplines * Managers * Technicians * Maintenance personnel * Other technical individuals Training Methods Your specialist course leader relies on a highly interactive training method to enhance the learning process. This method ensures that all participants gain a complete understanding of all topics covered. The training environment is highly stimulating, challenging, and effective because the participants will learn by case studies which will allow them to apply the material taught to their own organization. Each delegate will receive a copy of the following materials written by the instructor: * Industrial Instrumentation and Modern Control Systems Practical Manual (400 pages) Trainer Your specialist course leader has more than 32 years of practical engineering experience with Ontario Power Generation (OPG), one of the largest electric utility in North America. He was previously involved in research on power generation equipment with Atomic Energy of Canada Limited at their Chalk River and Whiteshell Nuclear Research Laboratories. While working at OPG, he acted as a Training Manager, Engineering Supervisor, System Responsible Engineer and Design Engineer. During the period of time, he worked as a Field Engineer and Design Engineer, he was responsible for the operation, maintenance, diagnostics, and testing of gas turbines, steam turbines, generators, motors, transformers, inverters, valves, pumps, compressors, instrumentation and control systems. Further, his responsibilities included designing, engineering, diagnosing equipment problems and recommending solutions to repair deficiencies and improve system performance, supervising engineers, setting up preventive maintenance programs, writing Operating and Design Manuals, and commissioning new equipment. Later, he worked as the manager of a section dedicated to providing training for the staff at the power stations. The training provided by him covered in detail the various equipment and systems used in power stations. In addition, he has taught courses and seminars to more than four thousand working engineers and professionals around the world, specifically Europe and North America. He has been consistently ranked as 'Excellent' or 'Very Good' by the delegates who attended his seminars and lectures. He written 5 books for working engineers from which 3 have been published by McGraw-Hill, New York. Below is a list of the books authored by him; * Power Generation Handbook: Gas Turbines, Steam Power Plants, Co-generation, and Combined Cycles, second edition, (800 pages), McGraw-Hill, New York, October 2011. * Electrical Equipment Handbook (600 pages), McGraw-Hill, New York, March 2003. * Power Plant Equipment Operation and Maintenance Guide (800 pages), McGraw-Hill, New York, January 2012. * Industrial Instrumentation and Modern Control Systems (400 pages), Custom Publishing, University of Toronto, University of Toronto Custom Publishing (1999). * Industrial Equipment (600 pages), Custom Publishing, University of Toronto, University of Toronto, University of Toronto Custom Publishing (1999). Furthermore, he has received the following awards: * The first 'Excellence in Teaching' award offered by PowerEdge, Singapore, in December 2016 * The first 'Excellence in Teaching' award offered by the Professional Development Center at University of Toronto (May, 1996). * The 'Excellence in Teaching Award' in April 2007 offered by TUV Akademie (TUV Akademie is one of the largest Professional Development centre in world, it is based in Germany and the United Arab Emirates, and provides engineering training to engineers and managers across Europe and the Middle East). * Awarded graduation 'With Distinction' from Dalhousie University when completed Bachelor of Engineering degree (1983). Lastly, he was awarded his Bachelor of Engineering Degree 'with distinction' from Dalhousie University, Halifax, Nova Scotia, Canada. He also received a Master of Applied Science in Engineering (M.A.Sc.) from the University of Ottawa, Canada. He is also a member of the Association of Professional Engineers in the province of Ontario, Canada. 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 post training support and fees applicable Accreditions And Affliations

COURSE INFORMATION Join our comprehensive course, meticulously designed to equip individuals implementing Good Clinical Laboratory Practice (GCLP) within laboratories handling samples from clinical trials. Delve into the current regulatory landscape governing laboratory work supporting clinical trials, referencing key guidelines such as the ICH Guideline for Good Clinical Practice, the Clinical EU Trials Directive, relevant regulations, and leveraging insights from the RQA guidance document on GCLP. IS THIS COURSE FOR YOU? This course is tailored for laboratory managers, analysts, investigators, trial coordinators, monitors, and auditors operating in diverse settings such as pharmaceutical company laboratories, central laboratories, contract research organisations, hospital laboratories, clinics, and investigator sites. THIS COURSE WILL GIVE YOU: * Guidance on effectively interpreting and applying GCLP within the broader framework of Good Clinical Practice (GCP) * Insight into the seamless integration of GCLP within clinical programmes (GCP) * Practical strategies for implementing GCLP in the nuanced environment of clinical research laboratories * The chance to update your knowledge with the latest interpretations and guidance on clinical laboratories by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) * Access to a seasoned panel of speakers with extensive expertise * A unique opportunity to deepen your understanding of GCLP's application across diverse scenarios. ENGAGE IN: * Lively discussions to foster ideas  * Problem-solving sessions targeting specific challenges * Detailed exploration of specific aspects within the realms of GCP and GCLP. -------------------------------------------------------------------------------- TUTORS Tutors will be comprised of (click the photos for biographies): VANESSA GRANT -, - LOUISE HANDY Director, Handy Consulting Ltd TIM STILES Consultant, Qualogy Ltd -------------------------------------------------------------------------------- PROGRAMME Please note timings may be subject to alteration. DAY 1 08:50 REGISTRATION 09:00 WELCOME AND INTRODUCTION 09:20 GOOD CLINICAL PRACTICE AND THE REQUIREMENTS OF GOOD CLINICAL LABORATORY PRACTICE A review of Good Clinical Practice and its requirements for the laboratory analysis of samples from a trial. The thought processes behind the development of Good Clinical Laboratory Practice, its objective, scope, interpretation and application are explained. 10:00 SAFETY AND ETHICAL CONSIDERATION Informed consent, confidentiality, expedited reporting, blinding and unblinding and serious breaches of the GCP are discussed. 10:40 BREAK 10:55 ORGANISATION AND PERSONNEL RESPONSIBILITIES WITHIN GCP AND THE LABORATORY The responsibilities of key functions that should exist within a clinical laboratory including personnel records of training and competence are discussed. 11:30 STAFF TRAINING AND TRAINING RECORDS Personnel records of training and competency assessments are discussed. 11:45 LABORATORY FACILITIES, EQUIPMENT AND MATERIALS Suitable facility design, organisation and operation will be discussed. The calibration, validation and maintenance of equipment used in the conduct of sample analysis are examined, as are the suitability of materials and the identification and labelling of reagents and solutions. 12:30 LUNCH 13:15 WORKSHOP 1 - FACILITIES, EQUIPMENT AND RESPONSIBILITIES Some practical problems with regard to the facilities, equipment and responsibilities are explored. 13:45 WORKSHOP 1 - FEEDBACK 14:15 COMPUTER SYSTEMS VALIDATION Systems, including computerised systems, used in the analysis, collection and reporting of results should be appropriately tested, operated and controlled. What this means in practice is discussed. 14:45 TRIAL PROTOCOLS, ANALYTICAL PLANS During this session we examine the purpose, content, control and change of these important documents. 15:30 BREAK 15:45 WORKSHOP 2 - SOPS, CLINICAL PROTOCOLS, ANALYTICAL PLANS AND VALIDATION The practicalities of managing and documenting the planning phase of analytical work on a trial are explored along with computerised system validation. 16:30 WORKSHOP 2 - FEEDBACK 17:00 CLOSE OF DAY DAY 2 09:00 CONDUCT OF THE WORK AND QUALITY CONTROL Many of the issues that surround the conduct of sample collection, shipment, storage, analysis and management of Analytical Methods are discussed. This includes the quality control of the assay that may be employed and Quality Control checks. 10:00 DEVIATION MANAGEMENT The expectations around deviations and CAPA are discussed. 10:15 WORKSHOP 3 - CONDUCT OF THE WORK AND QUALITY CONTROL Practical work conduct and quality control issues are explored. 10:45 BREAK 11:00 WORKSHOP 3 - FEEDBACK 11:30 SOURCE DATA, DATA INTEGRITY, RECORDS AND REPORTS The creation and subsequent management of source data and records, data integrity, are discussed, together with the process of reporting analytical results. 12:10 WORKSHOP 4 - DATA, RECORDS AND REPORTS Practical problems with data, records and reports are investigated. 12:45 LUNCH 13:30 WORKSHOP 4 - FEEDBACK 14:00 QUALITY AUDIT The requirements for and purpose of quality audits are discussed. The difference between quality audit and quality control are explained along with the role of the quality audit staff and their interaction with the analytical project managers, laboratory management and study staff. 14:40 RISK MANAGEMENT How should we assess risk and how can we use the process to assist in evaluation of audit findings. 15:15 BREAK 15:30 REGULATORY INSPECTION The conduct of regulatory inspections and current expectations of the inspectors. Preparation for inspections and conduct during them will be discussed. 16:00 PANEL SESSION This panel session will address any outstanding issues raised by the delegates. 16:15 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 This course offers foundational guidance and practical support tailored for individuals operating within Good Manufacturing Practice (GMP) frameworks. Explore the fundamental prerequisites of a pharmaceutical quality system (PQS) and delve into the application of quality risk management (QRM) principles, aligning with current regulations and guidance. Gain insights into pivotal aspects such as requirements, roles, and responsibilities, encompassing change control, document management, and key documentation essential for effective implementation of GMP with a focus on regulatory inspections and common findings. IS THIS COURSE FOR YOU? Ideal for professionals engaged in GMP across various sectors, including: * Research and Development (R&D) * Contract Manufacturing Organisations * Manufacturing Units * Quality Control (QC) Laboratories * Auditing Roles. WHAT WILL YOU LEARN? EVENT OBJECTIVES -  BY THE END OF THE COURSE, DELEGATES SHALL: * Have an awareness of the basic requirements of GMP * Be aware of UK and EU GMP Rules and Guidance and relevant publications * Understand the roles and responsibilities associated with GMP * Be able to contribute to and maintain quality documentation * Have a basic understanding of product lifecycle and manufacturing * Understand the requirements of GMP in the QC laboratory context * Have a basic understanding of risk management and mitigation principles * Understand the need for quality systems and quality assurance activities * Be aware of common regulatory findings. LEARNING OUTCOMES: DELEGATES WILL BE ABLE TO: * Implement their role within GMP with confidence and knowledge of the principle requirements * Contribute effectively to the GMP quality system and their organisation’s compliance * Comprehend where their organisation’s activities sit within the larger GMP arena * Know where to seek further information within the published rules and guidance, UK Legislation, European Commission Directives, ICH Guidance and other relevant publications, as well as via the internet. -------------------------------------------------------------------------------- TUTORS Tutors will be comprised of (click the photos for biographies): LOUISE HANDY Director, Handy Consulting Ltd -------------------------------------------------------------------------------- PROGRAMME Please note timings may be subject to alteration. DAY 1 09:30 INTRODUCTIONS AND SCOPE OF THE COURSE Understand the group requirements and the tutor's background and experience. 09:45 BACKGROUND AND REGULATORY ENVIRONMENT Setting the scene, understanding the context, key legislation. 10:30 PRINCIPLES OF GMP Key points and requirements. 11:15 BREAK 11:30 PERSONNEL AND RESPONSIBILITIES Management and staff, duties and accountabilities. 12:00 OVERVIEW OF GMP MANUFACTURING Basics of the product life cycle. 12:30 LUNCH 13:15 RISK MANAGEMENT WORKSHOP Practical exploration of risk and mitigation activities. 14:30 QC LABORATORIES Activities and practicalities. 15:15 BREAK 15:30 COMPLIANCE Quality Assurance and Self Inspection. 16:15 QUESTION TIME A chance for questions on the practicalities of GMP. 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 Our extensively proven course delves into the essential stages of process and system auditing. Gain invaluable insights and direction in auditing systems and processes, spanning across global and local organisational levels. 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 COURSE IS STRUCTURED TO ENCOURAGE DELEGATES TO: * Discuss and develop ideas * Solve specific problems * Share knowledge and experiences. BY THE END OF THE COURSE DELEGATES WILL BE BETTER ABLE TO: * Design and plan more effectively to achieve their process and systems audit objectives and add value to their organisation * Improve the effectiveness, focus and credibility of the audit programme * Understand the key system audit principles, preparation, design and conduct * Develop system audit tools to ensure more effective audit conduct and outcome * Create audit strategies utilising risk management principles * Prepare for inspections. -------------------------------------------------------------------------------- TUTORS Tutors will be comprised of (click the photos for biographies): ALLISON JACK Executive Director, Bristol Myers Squibb ROCIO CASTELLANOS Director, Pfizer Ltd GUY HOUBEN G(C)LP Auditor, Janssen Pharmaceutical Companies of Johnson & Johnson -------------------------------------------------------------------------------- PROGRAMME Please note timings may be subject to alteration. DAY 1 08:50 REGISTRATION 09:00 WELCOME AND INTRODUCTIONS, EXPECTATIONS/CHALLENGES/EXPERIENCES A discussion to explore the range of approaches to the conduct of systems audit. 09:30 INTRODUCING SYSTEMS AUDIT What is a system? Why conduct system audits? Advantages, disadvantages and challenges. 10:20 BREAK 10:35 SYSTEMS AUDIT DESIGN AND PLANNING Identifying the customer, setting objectives, development of the audit plan and audit tools, plans for the audit report. 12:00 DESIGNING SYSTEM AUDIT TOOLS 12:45 LUNCH 13:30 SYSTEM AUDIT PLAN - EXERCISE 14:00 INTRODUCTION TO CASE STUDIES The objectives of the case studies are defined and process and outputs described. 14:15 CASE STUDIES - SESSION 1 A first opportunity for work on case studies. Defining objectives and scope and understanding the requirements of the audit client. 15:00 BREAK 15:20 CASE STUDIES - SESSION 1 CONTINUED 16:30 CASE STUDIES - FEEDBACK 17:00 CLOSE OF DAY 1 DAY 2 09:00 SIMPLE SYSTEM AUDIT EXAMPLE - INTRODUCTION The objectives of the case studies are defined and process and outputs described. 09:10 CASE STUDIES - SESSION 2 - A SIMPLE SYSTEM AUDIT EXAMPLE An example of system audit applied to a simple system. 10:30 BREAK 10:45 A SIMPLE SYSTEM AUDIT EXAMPLE - CASE STUDY FEEDBACK 11:30 STRATEGY Audit programme planning. 12:15 LUNCH 13:00 CASE STUDIES - SESSION 3 Work on delegate's case studies. 14:30 BREAK 14:45 CASE STUDIES - SESSION 3 - FEEDBACK 15:15 CLOSING REMARKS 15:30 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