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The regulation of biological medicinal products is governed by different laws from those that apply to small-molecule synthetic drugs. Producing faithful copies of therapeutic proteins is more challenging than producing generic drugs. The US legal framework for the licensure of follow-on biologics, and accompanying regulatory guidance from the Food and Drug Administration (FDA), have been established only in recent years.

Having undergone Installation Qualification, before equipment can be used routinely in production, it needs to undergo Operational Qualification (OQ) and Performance Qualification (PQ). This module describes OQ and PQ requirements and procedures in the medicines and healthcare products industries. It follows the activities of a typical validation team as they carry out a project for a pharmaceutical company.

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his module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the MRP.

This module describes the roles of the various players in the procedure, the sequence and duration of the stages involved, and the requirements on content, format and timing of submissions. It discusses the special issues that apply to generic products in the DCP.

The sponsor of a clinical trial must arrange for it to be monitored throughout its duration to ensure that the rights and wellbeing of subjects are protected, the trial data are accurate, complete and verified from source documents, and the conduct of the trial complies with the study protocol, Good Clinical Practice and regulatory requirements. In this module we describe how a Clinical Research Associate (CRA) monitors an ongoing trial to its conclusion.

OET (Occupational English Test) is designed to meet the specific English language needs of the healthcare sector. It assesses the language proficiency of healthcare professionals who wish to practice in an English-speaking environment. All four language skills are assessed, with Writing and Speaking tests available in 12 different areas of healthcare. All candidates sit the same Reading and Listening tests. OET is accepted as proof of English proficiency in the UK, Ireland, Australia, New Zealand, Dubai, Namibia and Singapore for registration in 12 healthcare professions.

Level 5 QLS Endorsed Diploma | 150 CPD Points | +Gifts: QLS Certificate + PDF Certificate | 24/7 Learner Support

3 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | 10 CPD Courses | Lifetime Access | 24/7 Tutor Support

Description Basic Electricity Diploma Introducing the Basic Electricity Diploma, an expertly designed online course crafted to impart foundational knowledge and skills surrounding the realm of electricity. This course is tailored to meet the ever-evolving needs of individuals seeking to understand the core principles of electricity, from its safe application to advanced troubleshooting techniques. Every budding electrician, enthusiast, or professional aiming to refresh their knowledge should consider the Basic Electricity Diploma as an essential stepping stone. The content is not just a compilation of theory; it aims to prepare the learner for real-world application. The course starts with a pivotal module on Electrical Safety. Ensuring safety is not just a protocol, but a crucial part of working with electricity. This module ensures that students understand the fundamental safety protocols and potential hazards to be mindful of when working with electrical systems. Understanding the pathways electricity takes is vital. Circuit Analysis will provide learners with knowledge about how circuits function, the different components within them, and the importance of each in a fully functional system. Ever wondered about the motors that power so many of our daily appliances? The section on Electric Motors demystifies this by breaking down their functioning, types, and applications. Simultaneously, the Electrical Power Distribution Systems module introduces learners to the intricate systems in place to deliver electricity from its source to our homes and businesses. The distinction between AC and DC Circuits is foundational to anyone in the electrical field. This course ensures a thorough grasp of both, detailing their individual characteristics, benefits, and applications. Transformers and Capacitors play pivotal roles in the world of electricity. This section of the Basic Electricity Diploma discusses their functionality, importance, and the fundamental physics behind them. With the fast-paced technological advancements, Electrical Control Systems have become more sophisticated and intricate. This module covers the basics of these systems, offering insight into their operation and real-world application. No course on electricity would be complete without discussing the various Electrical Machines and Devices. This module provides an introduction to the most common machines and devices, from generators to common household appliances, shedding light on their workings. Adhering to the right guidelines is paramount. The Electrical Code and Standards module enlightens learners about the critical standards, both national and international, ensuring that all electrical work aligns with the highest levels of safety and quality. Lastly, the Troubleshooting Electrical Systems unit empowers learners with the skills and knowledge to diagnose and rectify common electrical issues, making them an invaluable asset in any electrical role. To sum it up, the Basic Electricity Diploma is a comprehensive online course designed to provide a robust foundation in electricity. From fundamental safety protocols to advanced topics like troubleshooting, this course covers it all, making it a must-have for anyone eager to embark on or advance their journey in the electrical domain. Equip yourself with the knowledge you need and take your electrical understanding to the next level. Register today! What you will learn 1:Electrical Safety 2:Circuit Analysis 3:Electric Motors 4:Electrical Power Distribution Systems 5:AC and DC Circuits 6:Transformers and Capacitors 7:Electrical Control Systems 8:Electrical Machines and Devices 9:Electrical Code and Standards 10:Troubleshooting Electrical Systems Course Outcomes After completing the course, you will receive a diploma certificate and an academic transcript from Elearn college. Assessment Each unit concludes with a multiple-choice examination. This exercise will help you recall the major aspects covered in the unit and help you ensure that you have not missed anything important in the unit. The results are readily available, which will help you see your mistakes and look at the topic once again. If the result is satisfactory, it is a green light for you to proceed to the next chapter. Accreditation Elearn College is a registered Ed-tech company under the UK Register of Learning( Ref No:10062668). After completing a course, you will be able to download the certificate and the transcript of the course from the website. For the learners who require a hard copy of the certificate and transcript, we will post it for them for an additional charge.