This one-hour self-paced eLearning course is designed for regulators and professionals in virtual pharmaceutical companies. It focuses on essential Good Manufacturing Practices (GMP) and compliance strategies. By the end of the training, participants will be able to describe the responsibilities of the Marketing Authorization Holder (MAH) and the Manufacturing Import Authorization (MIA) holders, understand and implement quality culture principles, manage outsourcing effectively, and navigate the challenges of batch release in a virtual environment. Additionally, learners will gain insights into data integrity practices and stay updated with the latest regulatory changes. Read more

This 40 minute self-paced learning course provides important GMP refresher Training required for all individuals involved in the manufacture and supply of medicinal products.  It provides a reminder of the different regulatory organisations globally that are responsible for defining Good Manufacturing Practice requirements, as well as updated and draft guidance documents from PIC/S, ICH and FDA.  It also provides detail on the significant changes to Annex 1 implemented in August 2023.  It highlights the most frequent inspection findings against cGMP from both the FDA and MHRA, as well as a reminder of the Golden Rules of GMP. Read more

The purpose of this course is to provide an overview of current Good Distribution Practices (GDP) and the fundamental requirements for a wholesale distribution authorisation holder and why GDP is so important in the provision of safe, efficacious medicines to our patients. Read more

This training course covers the GxP Inspection Management Lifecycle.  It is suitable for staff wanting to understand more about GCP, PV, GMP and GDP regulatory inspections from planning, conduct and responding to inspection findings.  Read more

This eLearning session provides an overview of the interface of GMP with GCP Quality Management Systems.  This course of four chapters will provide you with an understanding of the similarities and differences between GCP and GMP.  The chapters include short interactive quizzes to test your knowledge and following successful completion of the course, you will be issued with a certificate. (Note that course success and completion are based on finishing all of the content - not the quiz scores.) Read more

This introductory session (which is divided into 3 chapters) is ideal for staff in operational and support areas – production, engineering, QC, QA, validation and technical, as well as those new to the pharmaceutical industry and/or microbiology. We cover the real meaning of microbiology in operations and why it matters. You’ll learn the risks associated with microbes and how to eliminate or control them so that the patient is protected. You will be able to apply your knowledge from this session in your daily work. Read more