422 Pharmaceutical courses

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.

The warehouse plays a crucial role in a medicinal products factory. This module explains the requirements of Good Manufacturing Practice (GMP) for the warehouse, and how to comply with them.

This module addresses characteristic issues influencing the registration of medicinal products based on monoclonal antibodies (mAbs), for use in humans. Regulatory requirements for the registration of biological medicinal products such as those based on mAbs differ in certain respects from those for small-molecule products. This is because of the distinct characteristics of biologics, such as complex structure and susceptibility to variation during manufacture.

The CTD is the internationally recognised standard format for submissions to medicines regulatory authorities. In the European Economic Area, the USA and Canada, the CTD, in its electronic format (eCTD), is mandatory for all applications for marketing approval and all subsequent related submissions. The CTD is accepted in many other countries, being mandatory for new prescription medicines in some. This module explains the rationale for the CTD and provides guidance on its structure and format and the ways in which it is used.

Proactive risk management is a major component of good pharmacovigilance practice. This module sets out the principles of risk management planning and outlines regulatory requirements for risk management plans in regions that are major markets for medicinal products.

A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather than from the applicant’s own studies. The applicant typically proposes to market a drug that is based on an approved reference product but modified in its formulation or uses. A 505(b)(2) NDA also differs from an Abbreviated New Drug Application (ANDA) for approval of a generic drug in that the applicant’s product need not be a duplicate of the reference listed drug. The 505(b)(2) pathway may be said to lie part-way between the ‘stand-alone’ NDA and generics pathways, offering a unique combination of advantages to developers. It facilitates the modification of drugs to address unmet medical needs. The 505(b)(2) application pathway accounts for about half of all new drug approvals in the USA.

Overview of Biomedical Science Join our Biomedical Science 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 Biomedical Science course has everything you need to get a great start in this sector. Improving and moving forward is key to getting ahead personally. The Biomedical Science 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! This Biomedical Science Course will help you to learn: 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 Biomedical Science. 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 Biomedical Science 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. Shipping Charges: Inside the UK: £3.99 International: £10.99 Who Is This Course for? This Biomedical Science 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 You don't need any educational qualification or experience to enrol in the Biomedical Science 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 Biomedical Science 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 Biomedical Science Introduction to Biomedical Science 00:30:00 Module 02: Genetics and Biochemistry Genetics and Biochemistry 00:19:00 Module 03: Microbiology and Cell Biology Microbiology and Cell Biology 00:26:00 Module 04: Biochemical Engineering and Enzyme Discovery Biochemical Engineering and Enzyme Discovery 00:19:00 Module 05:Toxicology, Pharmaceuticals and Fine Chemicals Toxicology, Pharmaceuticals and Fine Chemicals 00:17:00 Module 06: Systems and Synthetic Biology Systems and Synthetic Biology 00:16:00 Module 07: Global Health Challenges Global Health Challenges 00:12:00 Assignment Assignment - Biomedical Science 00:00:00

Have you ever wondered how certain ingredients in your food affect your body on a cellular level? In this course, you'll explore the science behind cooking and how it relates to biomedical science. Learning outcomes: Understand the basics of genetics and biochemistry and how they relate to cooking. Explore the world of microbiology and cell biology and their impact on food safety and preservation. Learn about biochemical engineering and enzyme discovery, and their applications in the food industry. Understand the principles of toxicology and the role of pharmaceuticals and fine chemicals in food production. Discover the fundamentals of systems and synthetic biology, and how they relate to food production. Gain insight into global health challenges and how they impact the food industry. This course explores the fascinating intersection between cookery and biomedical science. Over seven modules, you'll delve into the science behind cooking and how it relates to biomedicine. You'll learn about the basics of genetics, biochemistry, microbiology, and cell biology, and explore how these areas of science affect the food we eat. You'll also discover the principles of biochemical engineering and enzyme discovery and learn how they can be applied in the food industry. In addition, you'll explore the world of toxicology and the role of pharmaceuticals and fine chemicals in food production. You'll gain an understanding of systems and synthetic biology and how they relate to food production, and examine global health challenges and their impact on the food industry. By the end of this course, you'll have a deep understanding of the science behind cooking and how it relates to biomedical science. Sign up for this course today and explore the fascinating world of cookery and biomedical science. Certification Upon completion of the course, learners can obtain a certificate as proof of their achievement. You can receive a £4.99 PDF Certificate sent via email, a £9.99 Printed Hardcopy Certificate for delivery in the UK, or a £19.99 Printed Hardcopy Certificate for international delivery. Each option depends on individual preferences and locations. CPD 10 CPD hours / points Accredited by CPD Quality Standards Who is this course for? Individuals interested in the science behind cooking and food production. Students pursuing degrees in biology, chemistry, or food science. Professionals working in the food industry who want to deepen their understanding of the science behind their work. Anyone interested in the intersection of cookery and biomedical science. Career path Biomedical scientist: £24,000 - £90,000 per year Food scientist: £23,000 - £50,000 per year Research scientist: £25,000 - £60,000 per year Toxicologist: £25,000 - £70,000 per year Enzyme scientist: £25,000 - £50,000 per year Synthetic biologist: £30,000 - £60,000 per year

Overview This comprehensive course on Biomedical Science will deepen your understanding on this topic. After successful completion of this course you can acquire the required skills in this sector. This Biomedical Science comes with accredited certification which will enhance your CV and make you worthy in the job market. So enrol in this course today to fast track your career ladder. How will I get my certificate? You may have to take a quiz or a written test online during or after the course. After successfully completing the course, you will be eligible for the certificate. Who is this course for? There is no experience or previous qualifications required for enrolment on this Biomedical Science. It is available to all students, of all academic backgrounds. Requirements Our Biomedical Science is fully compatible with PC's, Mac's, Laptop, Tablet and Smartphone devices. This course has been designed to be fully compatible on tablets and smartphones so you can access your course on wifi, 3G or 4G. There is no time limit for completing this course, it can be studied in your own time at your own pace. Career path Having these various qualifications will increase the value in your CV and open you up to multiple sectors such as Business & Management, Admin, Accountancy & Finance, Secretarial & PA, Teaching & Mentoring etc. Course Curriculum 8 sections • 8 lectures • 02:19:00 total length •Introduction to Biomedical Science: 00:30:00 •Genetics and Biochemistry: 00:19:00 •Microbiology and Cell Biology: 00:26:00 •Biochemical Engineering and Enzyme Discovery: 00:19:00 •Toxicology, Pharmaceuticals and Fine Chemicals: 00:17:00 •Systems and Synthetic Biology: 00:16:00 •Global Health Challenges: 00:12:00 •Assignment - Biomedical Science: 00:00:00

Explore the essence of Good Manufacturing Practice (GMP) and its pivotal role in ensuring the quality, safety, and consistency of pharmaceuticals, food, and other regulated products. Learn the principles, regulations, and best practices that guide GMP standards, fostering trust and integrity in the manufacturing process. Elevate your understanding of GMP compliance for a seamless journey from production to market, prioritizing consumer well-being and industry excellence.