Understanding specific words and terms used in the healthcare sector is an absolute must if you are looking to progress in this profession. Once you have a basic understanding of how medical words are constructed they become easy to understand and use are internationally used by nurses, doctors, allied healthcare professionals, dentists and many other medical specialities.
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.
Take our part-time online “Conversion Course into Pharmaceutical Manufacturing“ NO Previous Industry Experience or Science Qualifications Required
Take our part-time online “Conversion Course into Pharmaceutical Manufacturing“ NO Previous Industry Experience or Science Qualifications Required
Join leading body shape expert and Personal Stylist Abbey Booth, founder of Stories With Clothes, to discover your Body Shape. Feel more confident and understand what suits your shape and why!
Premium Bundle of all Time | Ofqual Regulation + ATHE Awards + QLS Endorsement | Assessment & Tutor Support Included
Take our part-time online “Conversion Course into Pharmaceutical Manufacturing“ NO Previous Industry Experience or Science Qualifications Required
This module outlines the legislative and regulatory context for the development of generic drugs and describes the essential role of the Abbreviated New Drug Application (ANDA) in gaining marketing approval. The use of information in the ‘Orange Book’ is explained, as is the role of patent certification in the application. The importance of establishing bioequivalence between a generic and its reference product is emphasised. The module specifies the content and format requirements for an ANDA submission and describes the FDA’s review and approval process. An outline is given of the Generic Drug User Fee Amendments (GDUFA) and the law’s effects on industry players.
Level 3, 4 & 7 QLS Endorsed Diploma | QLS Hard Copy Certificate Included | Plus 10 CPD Courses | Lifetime Access
Enhance your healthcare communication skills with our Medical Terminology and Abbreviation Course. Covering essential vocabulary, acronyms, and body systems, this course is perfect for aspiring professionals and current workers seeking to improve their understanding and application of medical language. Complete the course at your own pace and receive a certificate of achievement.