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Essential to validation is the provision of documented evidence verifying that manufacturing processes will consistently result in products meeting predetermined quality standards. This module describes the purpose, content and use of validation master plans, project validation plans, and other documentation for validation projects in the medicines and healthcare products industries. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.

Validation of equipment, services, systems and processes is vitally important in the medicines and healthcare products industries. Regulatory authorities require documented evidence that manufacturing processes will consistently result in products meeting predetermined quality standards. This module provides an introduction to validation and to the regulations and guidance that apply to it. It describes the activities of a typical validation team as they carry out a project for a pharmaceutical company.

This module describes the requirements that must be met to obtain licensure of a biological product. Subjects covered include the regulatory context, the content and format of the BLA submission, the review process, and provisions for expedited development and review.

Join our Level 3 Operations Management Diploma course and discover your hidden skills, setting you on a path to success in this area. Get ready to improve your skills and achieve your biggest goals. The Level 3 Operations Management Diploma course has everything you need to get a great start in this sector. Improving and moving forward is key to getting ahead personally. The Level 3 Operations Management Diploma course is designed to teach you the important stuff quickly and well, helping you to get off to a great start in the field. So, what are you looking for? Enrol now! You will Learn The Following Things: Learn strategies to boost your workplace efficiency. Hone your skills to help you advance your career. Acquire a comprehensive understanding of various topics and tips. Learn in-demand skills that are in high demand among UK employers This course covers the topic you must know to stand against the tough competition. The future is truly yours to seize with this Level 3 Operations Management Diploma. Enrol today and complete the course to achieve a certificate that can change your career forever. Details Perks of Learning with IOMH One-to-one support from a dedicated tutor throughout your course. Study online - whenever and wherever you want. Instant Digital/ PDF certificate 100% money back guarantee 12 months access Process of Evaluation After studying the course, an MCQ exam or assignment will test your skills and knowledge. You have to get a score of 60% to pass the test and get your certificate. Certificate of Achievement Certificate of Completion - Digital/PDF Certificate After completing the Level 3 Operations Management Diploma course, you can order your CPD-accredited Digital/PDF Certificate for £5.99.  Certificate of Completion - Hard copy Certificate You can get the CPD Accredited Hard Copy Certificate for £12.99. (Each) Shipping Charges: Inside the UK: £3.99 International: £10.99 Who Is This Course for? This Level 3 Operations Management Diploma is suitable for anyone aspiring to start a career in relevant field; even if you are new to this and have no prior knowledge, this course is going to be very easy for you to understand.  On the other hand, if you are already working in this sector, this course will be a great source of knowledge for you to improve your existing skills and take them to the next level.  This course has been developed with maximum flexibility and accessibility, making it ideal for people who don't have the time to devote to traditional education. Requirements There is no prerequisite to enrol in this course. You don't need any educational qualification or experience to enrol in the Level 3 Operations Management Diploma course. Do note: you must be at least 16 years old to enrol. Any internet-connected device, such as a computer, tablet, or smartphone, can access this online course. Career Path The certification and skills you get from this Level 3 Operations Management Diploma Course can help you advance your career and gain expertise in several fields, allowing you to apply for high-paying jobs in related sectors. Course Curriculum Module 01: Introduction to Operations Management Introduction to Operations Management 00:23:00 Module 02: Project Management Project Management 00:22:00 Module 03: Business Development and Succession Planning Business Development and Succession Planning 00:27:00 Module 04: Process Management Process Management 00:26:00 Module 05: Supply Chain Management Supply Chain Management 00:23:00 Module 06: Planning & Forecasting Operations Planning & Forecasting Operations 00:23:00 Module 07: Procurement & Purchasing Management Procurement & Purchasing Management 00:23:00 Module 08: Manufacturing & Delivery Operations Manufacturing & Delivery Operations 00:19:00 Module 09: Quality Management Quality Management 00:23:00 Module 10: Managing Risk and Recovery Managing Risk and Recovery 00:29:00 Module 11: Performance Management Performance Management 00:21:00 Module 12: Talent Management Talent Management 00:20:00 Module 13: Communication Skills Communication Skills 00:26:00 Module 14: Negotiation Techniques Negotiation Techniques 00:19:00 Module 15: Conflict Management Conflict Management 00:17:00 Module 16: Stress Management Stress Management 00:19:00 Module 17: Time Management Time Management 00:40:00 Module 18: Business Environment Business Environment 00:19:00 Module 19: Business Writing Skills Business Writing Skills 00:39:00

Has the Computer System Validation Engineer left and you’ve been handed their responsibilities? Do the thoughts of your next audit fill you with dread? CSV can be frustrating but this program will show you how to manage electronic data in a regulated manufacturing/laboratory/clinical environment using the GAMP framework and ensure compliance with FDA’s 21 CFR Part 11, EU Annex 11 or other regulatory guidelines.

The medicinal products industry is heavily regulated by governments. Within the industry’s Good Manufacturing Practice (GMP) framework, analytical laboratories engaged in quality control (QC) of starting materials, intermediates, bulk products, finished products, and packaging need to comply with relevant GMP standards. We refer to these as Good Quality Control Laboratory Practice, or GQCLP. Regulatory authorities inspect laboratories to confirm that they meet the standards. This course explains how to comply with GQCLP, and it provides advice on laboratory work in general.

24-Hour Flash Sale! Prices Reduced Like Never Before!! The UK's manufacturing and construction sectors are pivotal for its growth, contributing significantly to the economy and employing millions. However, within these industries, welding remains a critical skill. With an increasing demand for skilled welders and safety practitioners, there's never been a better time to acquire welding skills and relevant safety knowledge. The Welding Training bundle offers knowledge based on UK standards, addressing both skills and safety protocols necessary in today's job market. The course bundle encompasses topics ranging from foundational Welding Techniques and Manufacturing Engineering to specialised safety courses such as Working in Confined Spaces, Manual Handling, and Electrical Safety. It also covers critical compliance topics like Asbestos Awareness, COSHH Training, and Gas Safety Legislation. Designed for a holistic education, the curriculum balances welding skills with a strong emphasis on safety and regulatory knowledge, preparing participants for the multifaceted demands of the industry. Courses Included In this Welding Training Are: Course 01: Welding Training (UK Standard) Course 02: Manufacturing Engineering - Welding Course 03: Welding Basics and Safety Course 04: Abrasive Wheels Course 05: Manual Handling Interactive Training Course 06: Working in Confined Spaces Course 07: Basic Electricity Course Course 08: Portable Appliance Testing (PAT) - CPD Accredited Course 09: Professional Plumbing Course Course 10: Asbestos Surveying & Management Training Course 11: Asbestos Awareness Course 12: COSHH Training Course 13: PUWER Course 14: Workplace First Aid Level 4 Course 15: Working at Height Course 16: Lone Worker Safety Course 17: Construction Safety Course 18: Electrical and Fire Safety Training Course 19: Gas Safety Legislation Course 20: Ladder Safety Grab this opportunity to elevate your career in welding and construction safety. Whether you're starting out or looking to enhance your skills, this training bundle provides the knowledge and certification needed to stand out in the competitive job market. Join a community of professionals dedicated to excellence and safety in the welding industry and pave your way to a rewarding career today. Enrol now!! Learning Outcomes of this Welding Training Course Master foundational and advanced welding techniques. Understand manufacturing engineering principles in welding. Apply safety practices in welding and related activities. Navigate regulations with asbestos, COSHH, and gas safety training. Learn electrical and fire safety measures applicable in work environments. Ensure personal and workplace safety in confined spaces and heights. Why Prefer Us? Get a free CPD Accredited Certificate upon completion of the Welding course Get a Free Student ID Card with Welding Training The Welding course is Affordable and Simple to understand Lifetime Access to the Welding course materials The Welding course comes with 24/7 Tutor Support Welding is a procedure that involves using electricity and torches to generate heat and solder metal components together. This course is comprehensive, so you can be confident that all the information is correct and up to date. The course is incredibly lively and well-paced, allowing you to understand Welding easily. You'll learn how to perfect your skills while examining relevant and important topics. *** Course Curriculum *** Here is the curriculum breakdown of this course: Course 01: Welding Training (UK Standard) Module 01: Introduction Module 02: Getting Familiar with Metals Module 03: Exploring Methods Module 04: Knowing the Metals Module 05: Preparing Steel for Welding Module 06: Working with Stainless Steel Module 07: Working with Aluminium and Other Metals Module 08: MIG Tutorial Module 09: TIG Tutorial Module 10: Arc Tutorial Module 11: Illness Caused by Fume and Gases Module 12: Fume - Reducing the Risk Module 13: Hearing Loss and Vibration White Finger Module 14: Other Safety Issues Module 15: Protection During Welding Module 16: Safety in Gas Welding Course 02: Manufacturing Engineering - Welding Module 01: Introduction Module 02: Liquid State Welding Module 03: Solid-State Welding Module 04: Liquid-Solid State Welding Module 05: Miscellaneous Course 03: Welding Basics and Safety Module 01: The World of Welding Module 02: Welding Safety Module 03: Welding Tools and Preparation Module 04: Welding Methods =========>>>>> And 17 More Courses <<<<<========= How will I get my Certificate? After successfully completing the course, you will be able to order your Certificates as proof of your achievement. PDF Certificate: Free (Previously it was £12.99*20 = £260) CPD Hard Copy Certificate: Free (For The First Course: Previously it was £29.99) CPD 200 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Anyone interested in learning more about the topic is advised to take this bundle. This bundle is ideal for: Aspiring welders Safety officers Manual workers Construction personnel Engineers Requirements You will not need any prior background or expertise to enrol in this Welding Course. Career path After completing this bundle, you are to start your career or begin the next phase of your career. Certified Welder - £25,000 to £40,000 Welding Inspector - £30,000 to £50,000 Construction Manager - £40,000 to £65,000 Manufacturing Engineer - £30,000 to £50,000 Electrical Safety Officer - £28,000 to £45,000 Certificates CPDQS Accredited Digital Certificate Digital certificate - Included Upon passing the Course, you need to order a Digital Certificate for each of the courses inside this bundle as proof of your new skills that are accredited by CPD QS for Free. CPDQS Accredited Hard Copy Certificate Hard copy certificate - Included If you are an international student, then you have to pay an additional 10 GBP as an international delivery charge.

The Assembly Operative Training Course offers a thorough introduction to the essential concepts and processes behind efficient assembly operations. This course guides learners through every key aspect, from understanding assembly tools and materials to mastering the setup and maintenance of assembly lines. Emphasis is placed on creating smooth, well-organised workflows that contribute to production quality and operational success. Beyond the technical elements, the course covers important health and safety principles tailored to assembly environments, alongside relevant laws and regulations that shape manufacturing practices. Communication within the assembly context is also explored to ensure effective teamwork and coordination. With a focus on continuous improvement and modern assembly techniques, this training equips learners with the knowledge to confidently engage with evolving manufacturing technologies and enhance overall line performance. Ideal for those seeking to broaden their understanding of assembly processes within a professional framework. Key Features CPD Accredited FREE PDF + Hardcopy certificate Fully online, interactive course Self-paced learning and laptop, tablet and smartphone-friendly 24/7 Learning Assistance Discounts on bulk purchases Course Curriculum of Assembly Operative Module 01 : Introduction To Assembly Operations Module 02 : Assembly Tools And Materials Module 03 : Assembly Line Setup and Maintenance Module 04 : Health And Safety In Assembly Operations Module 05 : Laws And Regulations In Manufacturing Module 06 : Communication In Assembly Operations Module 07 : Assembly Line Performance and Continuous Improvement Module 08 : Advanced Assembly Techniques and Technologies Learning Outcomes: Master fundamental assembly techniques for efficient production. Identify and utilize various assembly tools and materials effectively. Implement health and safety protocols in assembly operations seamlessly. Demonstrate compliance with manufacturing laws and regulations. Enhance communication skills crucial for teamwork on the assembly line. Drive continuous improvement in assembly line performance. Accreditation This course is CPD Quality Standards (CPD QS) accredited, providing you with up-to-date skills and knowledge and helping you to become more competent and effective in your chosen field. CPD 10 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Individuals aspiring to start a career in assembly operations. Entry-level workers seeking to enhance their manufacturing skills. Manufacturing enthusiasts keen on mastering assembly techniques. Professionals looking to transition into the manufacturing sector. Students aiming to gain specialized knowledge in assembly operations. Individuals committed to ensuring safety and compliance in production. Career path Assembly Line Operator Manufacturing Technician Quality Control Inspector Production Coordinator Warehouse Associate Maintenance Technician Certificates Digital certificate Digital certificate - Included Once you've successfully completed your course, you will immediately be sent a FREE digital certificate. Hard copy certificate Hard copy certificate - Included Also, you can have your FREE printed certificate delivered by post (shipping cost £3.99 in the UK). For all international addresses outside of the United Kingdom, the delivery fee for a hardcopy certificate will be only £10. Our certifications have no expiry dates, although we do recommend that you renew them every 12 months.

A company’s Corrective and Preventive Action (CAPA ) system establishes how personnel should deal with manufacturing problems that have occurred or that may occur if not prevented. This module explains the principles of corrective and preventive action and describes typical CAPA procedure. It goes on to introduce root cause analysis and outline the role of progress tracking, escalating, and trending of CAPA procedures.

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.