Data integrity has been a focus for pharmaceutical regulatory inspections for several years. Many inspection reports from regulatory agencies such as the FDA and EMA cite data integrity as a cause of observations and enforcement action. In serious cases regulators ceased commercial activities of manufacturers on the grounds of data integrity violations.
This data integrity training course explains the background to data integrity regulations and sets out the expectations of pharmaceutical regulators. It will provide you with the knowledge and practical skills to implement data integrity best practice. Ultimately the aim of this course is to minimise any data integrity issues or violations by maintaining high quality data integrity processes. The course explains how to take a risk-based approach to data integrity compliance, electronic record keeping (GAMP 5) ALCOA for pharmaceutical records and conducting your own data integrity audits.
With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.