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
Average entry-level pharma roles pay 96% of NHS Band 5 and come with opportunities for overtime, shift allowance and additional benefits as well as huge scope for career progression and salary increases.
Take your knowledge to the next level with EnergyEdge course on Layer of Protection Analysis (LOPA). Enroll now to advance your career.
24 Hour Flash Deal **25-in-1 Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences Mega Bundle** Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences Enrolment Gifts **FREE PDF Certificate**FREE PDF Transcript ** FREE Exam** FREE Student ID ** Lifetime Access **FREE Enrolment Letter ** Take the initial steps toward a successful long-term career by studying the Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences package online with Studyhub through our online learning platform. The Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences bundle can help you improve your CV, wow potential employers, and differentiate yourself from the mass. This Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences course provides complete 360-degree training on Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences. You'll get not one, not two, not three, but twenty-five Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences courses included in this course. Plus Studyhub's signature Forever Access is given as always, meaning these Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences courses are yours for as long as you want them once you enrol in this course This Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences Bundle consists the following career oriented courses: Course 01: Pharmacy Assistant & Pharmacy Technician Course 02: Diploma in Pharmacy Skills Course 03: Medication Administration: Control and Administration of Medicine Course 04: Medication Administration and Preservation Course 05: Medical Transcription Diploma Course 06: Nurse Prescribing and Medicine Management Course 07: Immunisation Nurse Course 08: Pharmacology Diploma Course 09: Healthcare GDPR Certificate Course 10: Biomedical Science Course 11: Medical Secretary Certification Course 12: Diploma in Laboratory Technician Course 13: Medical Receptionist Course 14: Medical & Clinical Administrator Course 15: Medical Law Course 16: Essentials of European Medical Device Regulations Course 17: Medical Writing Course 18: Phlebotomy Course 19: Observation Skills for Carers Course 20: Pain Management Course 21: English for Healthcare Course 22: Common Childhood Illnesses & Paediatric First Aid Course 23: Diabetes Awareness Training Course 24: Clinical Research Administration: Navigating the Healthcare Landscape Course 25: Personal Hygiene The Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences course has been prepared by focusing largely on Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences career readiness. It has been designed by our Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences specialists in a manner that you will be likely to find yourself head and shoulders above the others. For better learning, one to one assistance will also be provided if it's required by any learners. The Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences Bundle is one of the most prestigious training offered at StudyHub and is highly valued by employers for good reason. This Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences bundle course has been created with twenty-five premium courses to provide our learners with the best learning experience possible to increase their understanding of their chosen field. This Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences Course, like every one of Study Hub's courses, is meticulously developed and well researched. Every one of the topics is divided into Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences Elementary modules, allowing our students to grasp each lesson quickly. The Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences course is self-paced and can be taken from the comfort of your home, office, or on the go! With our Student ID card you will get discounts on things like music, food, travel and clothes etc. In this exclusive Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences bundle, you really hit the jackpot. Here's what you get: Step by step Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences lessons One to one assistance from Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciencesprofessionals if you need it Innovative exams to test your knowledge after the Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciencescourse 24/7 customer support should you encounter any hiccups Top-class learning portal Unlimited lifetime access to all twenty-five Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences courses Digital Certificate, Transcript and student ID are all included in the price PDF certificate immediately after passing Original copies of your Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences certificate and transcript on the next working day Easily learn the Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences skills and knowledge you want from the comfort of your home CPD 250 CPD hours / points Accredited by CPD Quality Standards Who is this course for? This Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences training is suitable for - Students Recent graduates Job Seekers Individuals who are already employed in the relevant sectors and wish to enhance their knowledge and expertise in Pharmacy technician Training: Advanced Skills in Pharmaceutical Sciences Requirements To participate in this Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences course, all you need is - A smart device A secure internet connection And a keen interest in Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences Career path You will be able to kickstart your Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences career because this course includes various courses as a bonus. This bundle is an excellent opportunity for you to learn multiple skills from the convenience of your own home and explore Pharmacy Technician Training: Advanced Skills in Pharmaceutical Sciences career opportunities. Certificates CPD Accredited Certificate Digital certificate - Included CPD Accredited e-Certificate - Free CPD Accredited Hardcopy Certificate - Free Enrolment Letter - Free Student ID Card - Free
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
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
Drug safety monitoring and risk management are vitally important for medicinal product developers, licence holders and clinical investigators. In addition to their duty to protect public health, increasingly tight regulation and potentially massive payments to litigants provide strong incentives for pharmaceutical and biotechnology companies to ensure that they maintain efficient systems for drug safety / pharmacovigilance and that all staff are aware of the basic requirements. This course will provide them with an overview of the most important aspects of this discipline, both before and after marketing of products, especially as they apply in Europe and the USA.
The New Drug Application (NDA) is the regulatory vehicle through which sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for marketing and sale in the USA.