This one-hour self-paced eLearning course provides essential 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 a reminder of the Golden Rules of GMP.  It highlights the most frequent regulatory inspection findings against cGMP from both the FDA and MHRA, as well as providing an enhanced focus on data integrity.  It concludes with providing an overview of those evolving areas of GMP, such as CSV and the impact of digital solutions (AI and ML), regulatory focus on security of supply and the impact on the environment. This course includes a competency assessment that, with successful completion, leads to a certificate of completion.  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

Begin your journey into supplier quality management with this foundational course. Discover the regulatory requirements from FDA, EU GMP, and WHO guidelines while exploring the essential concepts of supplier selection, qualification, risk assessment, and performance monitoring. This introductory module establishes the critical framework for understanding how effective supplier relationships directly impact product quality, patient safety, and business success. Build your foundational knowledge of the four-stage supplier lifecycle and learn why robust supplier quality management is both a regulatory imperative and a strategic business advantage. Read more