21CFR11 applies to records that are required to be submitted to the FDA, or that are subject to FDA inspection, and that are in electronic form – that is, as computer files. It applies to all computer systems used to create, modify, maintain, archive, retrieve, or transmit such records – from a humble spreadsheet program to a complex information management system.
In this short course we present an overview of the main principles of GMP, and we outline some things that manufacturing personnel need to do to comply with requirements. We identify the principal goals of GMP as: prevention of contamination; prevention of mix-ups; scrupulous documentation; validation and maintenance of processes and equipment; quality assurance by an independent unit; and training. We place GMP in the context of a company’s quality management system.
About this Training Course This 5 full-day course provides detailed description of all combustion equipment and systems used in pulverized coal boilers and circulating fluidized bed (CFB) boilers including pulverized coal burning systems, coal feeder, pulverizer and classifier, pulverized coal burners, furnace and fans. This course provides also a comprehensive explanation of all boiler combustion control systems including pulverizer control system, combustion control, control of coal and air flow into the boiler, furnace pressure control, oxygen trim control, nitrogen oxides (NOx) and sulfur oxides (SOx) control, control of ammonia injection, flue gas dew point control, purge control, flame monitoring and tripping system as well as their tuning methods. All boiler control systems are covered as well in this course including drum level feedwater control, main steam and reheat steam temperature control, boiler limits and runback, sliding or variable pressure control, heat rate optimization with sliding pressure control, boiler-turbine coordinated control, etc. The course provides also detailed explanation of Boiler NFPA 85 Code (Boiler and Combustion Systems Hazards Codes) and American National Standard Institute/Instrument Society of America Code (ANSI/ISA-77-44-01-2007 Code). The burner management systems (BMS) and examples of boiler permissive starting logic and protective tripping logic will be explained thoroughly. The various methods used to calculate the boiler efficiency are covered in detail in this course including the direct and indirect methods. All the factors which affect the efficiency and emissions of pulverized coal boiler and CFB boiler will be explained thoroughly. The course covers also all the methods used to improve the efficiency of pulverized coal boilers and CFB boilers including improvement to their combustion efficiency and control systems performance. Training Objectives Boiler Combustion Equipment and Systems: Gain an in-depth understanding of all boiler combustion equipment and systems including pulverized coal burning systems, coal feeder, pulverizer and classifier, pulverized coal burners, furnace and fans Boiler Combustion Control Systems: Gain a thorough understanding of all boiler combustion control systems for pulverized coal boilers, and CFB boilers including pulverizer control system, combustion control, control of coal and air flow into the boiler, furnace pressure control, oxygen trim control, nitrogen oxides (NOx) and sulfur oxides (SOx) control, control of ammonia injection, flue gas dew point control, purge control, flame monitoring and tripping system Boiler Conventional Control Systems: Gain an in-depth understanding of all boiler conventional control systems including drum level feedwater control, main steam and reheat steam temperature control, boiler limits and runback, sliding or variable pressure control, heat rate optimization with sliding pressure control, and boiler-turbine coordinated control Boiler NFPA 85 Code (Boiler and Combustion Systems Hazards Codes) and American National Standard Institute/Instrument Society of America Code (ANSI/ISA-77-44-01-2007 Code): Learn about NFPA 85 code and ANSI/ISA-77-44-01-2007 code Burner Management System and Boiler Permissive Starting Logic and Protective Tripping Logic: Gain an in-depth understanding of burner management system and boiler permissive starting logic and protective tripping logic Boiler Efficiency Calculations: Learn how to calculate the boiler efficiency using the direct and indirect methods Factors Affecting the Efficiency and Emissions of Boilers: Understand all the factors which affect the boiler efficiency and emissions Methods Used to Improve the Efficiency of Boilers: Learn about all the methods used to improve the efficiency of pulverized coal boilers, and CFB boilers including improvement to their combustion efficiency and control systems performance Boiler Instrument and Piping Diagrams: Gain an in-depth understanding of all boiler instrument and piping diagrams CFB and Pulverized Coal Boilers Equipment and Systems: Learn about various types of equipment and systems used in CFB and pulverized coal boilers including economizers, steam drum, superheaters, air preheaters, ammonia injection systems, etc. Target Audience Engineers of all disciplines Managers Technicians Maintenance personnel Other technical individuals Course Level Basic or Foundation 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: Excerpt of the relevant chapters from the 'POWER GENERATION HANDBOOK' second edition published by McGraw-Hill in 2012 (800 pages) Excerpt of the relevant chapters from the 'POWER PLANT EQUIPMENT OPERATION AND MAINTENANCE GUIDE' published by McGraw-Hill in 2012 (800 pages) COMBUSTION ENGINEERING FOR COAL FIRED POWER PLANTS MANUAL (includes practical information about combustion engineering for coal fired power plants - 550 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
Traibcert Awareness online course is a comprehensive package that delves into every nook and corner you deserve to know about ISO 9001, including all the erstwhile requirements and pragmatic impeccability for compliance. The course is durably defined for noviceswho exhibit greataffinity towards quality management and ISO standards.
2 QLS Endorsed Course | CPD Certified | Free PDF & Hard Copy Certificates | 180 CPD Points | Lifetime Access
3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | 10 CPD Courses | Lifetime Access | 24/7 Tutor Support
Definitive Salt training course description Salt is a remote execution framework and configuration management system. This course covers Salt from the basics. After a quick first taste the course moves onto execution modules, salt states, minion and master data, jinja, Salt extensions and then topology and configuration options. Hands on sessions are used to reinforce the theory rather than teach specific manufacturer equipment. What will you learn Install and use Salt. Describe the architecture of Salt. Manage configurations with Salt. Extend Salt. Definitive Salt training course details Who will benefit: Anyone working with Salt. Prerequisites: Linux fundamentals. Duration 2 days Definitive Salt training course contents Introduction What is Salt? High- level architecture, Some quick examples, system management, configuration management, A brief history, Topology options, Extending Salt. Quick start: First taste of Salt Single-master setup, from packages, bootstrap scripts, Starting up, Basic commands, salt: the main workhorse, salt-key: key management, salt-call: execution on the minion, salt-run: co-ordination of jobs on the master, summary of commands, Key management, viewing keys, accepting keys, rejecting keys, key files, Minion targeting, minion ID, list (-L), glob, regular expressions (-E), grains (-G), compound (-C), targeting summary, Additional remote execution details, Conclusion. Execution modules: The functional foundation sys: information and documentation about modules, sys.doc basic documentation, sys.list_modules, sys.list_functions: simple listings, cmd: execute via shell, cmd.run: run any command, pkg: manage packages, virtual modules, pkg.lists_pkgs: list all installed packages, pkg.available version: see what version will be installed, pkg.install: install packages, user: manage users, user.add: add users, user.list_users, user info: get user info, saltutil: access various Salt utilities, Summary. Configuration management: Salt states Salt files overview, SLS example: adding a user, working with the multi-layered state system, Highstate and the top file, the top file, State ordering, require: depend on another state, watch: run based on other changes, odds and ends, Summary. Minion data / master data Grains are minion data, performing basic grain operations, setting grains, targeting with grains in the top file, Pillars are data from the master, querying pillar data, querying other sources with external pillars, Renderers give data options. Extending Salt: part I Introduction to Jinja, Jinja basics, Templating with Jinja, filtering by grains, Custom execution module, Custom state modules, Custom grains, External pillars, Summary. More on the matter Runners, manage minions, manage jobs, The orchestrate runner, The event system, The reactor system, Summary. Extending Salt: part II Python client API, reading configuration data on a master and minion, using the master client (localclient) API, Using the caller client API, Custom runners, writing a custom runner, using the runnerclient API, Summary. Topology and configuration options Master configuration, directories and files, logging, access control, files server options, Topology variations, masterless minions, peer systems, syndication masters, multiple masters. Brief introduction to salt-cloud Overview, Setup AWS and salt-cloud, installing salt-cloud, cloud providers, cloud profiles, cloud maps, Introspection via salt cloud, Creating infrastructure, More information. Using vagrant to run Salt examples YAML.
Description This Compliance Manager Diploma is designed for all organizations that wish to improve Compliance Management, which is the core element of a functioning management system. Being able not only to monitor but to manage compliance in your organisation constitutes one of the building blocks to guarantee an effective implementation of a management system as required regulations for any aviation organization. The Compliance Manager Diploma will provide you with a deep understanding of aviation related requirements for a Compliance Management System including requirements related to documentation, audit techniques, reporting and management of records. Furthermore it will provide you with guidance on how to ensure your Compliance Management will cooperate with your SMS and how to verify the functionality and regulatory compliance of your SMS. Through the course you will receive both the theoretical background and the tools and practical knowledge needed to successfully implement and operate Compliance Management to strengthen your Management System. Assessment: This course does not involve any MCQ test. Students need to answer assignment questions to complete the course, the answers will be in the form of written work in pdf or word. Students can write the answers in their own time. Once the answers are submitted, the instructor will check and assess the work. Certification: After completing and passing the course successfully, you will be able to obtain an Accredited Certificate of Achievement. Certificates can be obtained either in hard copy at a cost of £39 or in PDF format at a cost of £24. Who is this Course for? Compliance Manager Diploma is certified by CPD Qualifications Standards and CiQ. This makes it perfect for anyone trying to learn potential professional skills. As there is no experience and qualification required for this course, it is available for all students from any academic background. Requirements Our Compliance Manager Diploma is fully compatible with any kind of device. Whether you are using Windows computer, Mac, smartphones or tablets, you will get the same experience while learning. Besides that, you will be able to access the course with any kind of internet connection from anywhere at any time without any kind of limitation. Career Path After completing this course you will be able to build up accurate knowledge and skills with proper confidence to enrich yourself and brighten up your career in the relevant job market. Module: 01 Compliance Manager 00:30:00 Compliance Management System 00:30:00 The Compliance House 00:30:00 Compliance and Auditing 00:30:00 Compliance and Ethics 00:30:00 Module: 02 Understanding Risk 00:30:00 Risk Management Activities 00:05:00 Assessing Risk 00:15:00 Responding to Risks 00:15:00 Resourcing Controls 00:05:00 Reaction Planning 00:15:00 Reporting and Monitoring 00:15:00 Module: 03 Information Security Risk Management 00:30:00 Risk Management 00:30:00 Risk Reporting and Communication 00:30:00 External and Internal Factors 00:30:00 Strategic Risk Management 00:15:00 Risk Analysis and Assessment 00:45:00 Enterprise Risk Management (ERM) 00:45:00 Module: 04 The Role And Responsibilities of a Security Officer 00:30:00 Security Management Governance 00:15:00 The Basics Of Security Management 00:15:00 Security Management Planning And Implementing 00:15:00 How to Build a Security Management Team 00:15:00 Assessment Assignment - Compliance Manager Diploma 00:00:00 Certificate and Transcript Order Your Certificates and Transcripts 00:00:00
Traibcert Awareness online course is a comprehensive package that delves into every nook and corner you deserve to know about ISO 13528, including all the erstwhile requirements and pragmatic impeccability for compliance. The course is durably defined for novices who exhibit great affinity towards Proficiency testing by inter laboratory comparison management and ISO standards.