The purpose of this course is to provide an introduction to Pharmacovigilance and why it is required to monitor the detection, assessment and prevention of adverse events, adverse reactions and side effects of medicinal products post marketing. Read more

This 45 minute self-paced learning course provides an overview of the requirements of a change control process. The change control system provides a systematic approach to managing all GxP changes made to a product or system. The review and approval of changes prior to their implementation allows us to ensure that no unnecessary changes are made and the proposal is risk assessed to determine if there will be an impact to product safety, quality, efficacy, ultimately to ensure that the patient is not harmed by any changes made. Read more

This course of four chapters will give you a sound basis of the regulatory requirements expected of a good pharmaceutical cleaning process, how to calculate limits and their justification. The pros and cons of various cleaning methods and how to approach them. Finally, how to plan and approach a validation exercise with specific cleaning acceptance criteria. Read more

This course provides an overview of the US and EU regulatory framework relative to combination products.  This course will discuss the primary mode of action (PMOA), key stakeholders, and Drug-Device Combination (DDC) product requirements as well as a brief discussion of the regulatory framework for jurisdictions beyond the US and EU. This course is approximately 1.5 hours in length and includes knowledge checks after each topic and a competency assessment.  Read more

The purpose of this course is to provide an overview of current good CSV practice along with some practical advice about how to achieve good outcomes in a cost-effective and resource-efficient way. Read more

Course 1 of our Data Integrity Series Problems with data integrity continue to lead to vigorous regulatory actions. Such issues can be prevented with a thorough knowledge and understanding of the regulators’ requirements.  This eLearning course is aimed at anyone working in the Pharmaceutical Industry and is designed to provide an overview of what is meant by data integrity, what needs to be considered during documentation completion, review and approval and how to keep your data complete, consistent and accurate throughout the data lifecycle. This course is course 1 of our Data Integrity series.   Read more