Pharmaceutical Product Lifecycle Management

The information that forms the records of an operating facility are increasingly being recognized as a vital part of a facility. This ' digital asset' reflects the value of data that mirrors the physical assets. The genesis of this digital asset (engineering data) is created and collected from various disparate sources. This information is also consumed by a variety of disparate functions. To facilitate the efficient creation, manipulation and consumption of engineering information it is important to define a master data model for the whole asset lifecycle. The identification of the…

Through lecture and group exercises this course illustrates how quality systems work, the purpose of the different elements, how they connect to each other and how to recognize and transfer knowledge/connectivity throughout the organization. The diagram below from ICH Q10, covers the product life cycle for a PQS/QMS system and all aspects will be covered by this course.

This interactive advanced workshop uses case studies to provide practical tools and techniques to identify solutions for applying QRM principles to current challenges and provides hands-on experience with preparing for and facilitating risk assessments.