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.
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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.
This is a practical course that will help you understand the features of SwiftUI. You will gain all the essential knowledge of SwiftUI and declarative programming needed to build fun and stylish applications for macOS.
The course is crafted to reflect the most in-demand workplace skills. It will help you understand all the essential concepts and methodologies with regards to PySpark. This course provides a detailed compilation of all the basics, which will motivate you to make quick progress and experience much more than what you have learned.
Looking to refine your baristas’ skills or retrain your team for peak performance behind the bar? Our half-day Barista Espresso & Milk Training is designed specifically for cafés that want to elevate their coffee game. This streamlined version of our SCA Barista Foundation course focuses on the essentials: • Dialling in espresso quickly – Learn how to adjust grind size, dose, and extraction time for consistent, high-quality espresso. • Milk texturing techniques – Master silky microfoam for perfect lattes, flat whites, and cappuccinos. • Workflow & efficiency – Improve speed and consistency during service without compromising quality. Please note this is not an SCA-certified training, and no SCA certificate will be issued upon completion. However, trainees will receive a certificate from Etude Coffee to recognize their participation. This course is free for our wholesale partners! If you're a partner, use your discount code at checkout to book your team in. Invest in your team and improve your coffee standards. Book your spot now.
Unlock Your Interior Design, Creative Superpower is designed to get you thinking about how the energy of your home influences your life.. productivity, creativity and relationships.