Course description
Manufacturing Execution Systems (MES), fully integrated to enterprise, quality, and shop floor equipment and automation systems, have become mainstream practice in regulated life sciences manufacturing environments as the industry embraces Pharma 4.0 ideologies. Patient risk due to manufacturing and supply errors can be significantly reduced by well implemented Electronic Production Systems as these systems bring consistent control, data integrity, and governance to manufacturing batches. Pharmaceutical regulators have recognised this and have provided regulatory frameworks to encourage risk based electronic manufacturing. Moreover, many evolving Pharma 4.0 supporting technologies (e.g. Augmented & Virtual Reality devices, wearable biometric devices, digital twins, predictive analytics & AI tools) rely on the foundational real-time data captured by Electronic Production Systems for value-adding use cases. Despite the overwhelming quality & business benefits of MES/Automation technologies, companies still struggle to understand their full nature, context, & potential due to perceived complexity, breadth of supplier offerings, different business challenges for different manufacturing modalities, and different industry narratives (industry noise).
This broad course,which is MES solution-agnostic, will help to demystify MES and associated automation technologies for all levels of regulated life sciences stakeholders and practitioners.
- For technical resources (e.g. engineers, IT, validation, operations) involved in specific technology deployment areas, it will explain the context of technical specifics relative to the broader integrated manufacturing and associated standards.
- For business level stakeholders, it will show the business big picture of MES across the broader manufacturing supply chain as well as the business justification & risks for different manufacturing modalities (e.g. Oral dose, bulk API, cell & gene therapy, biotech, devices etc.).
- For Quality professionals, we will discuss the GxP risks, regulatory trends, validation, and the role of quality in deployment and operation of these technologies.
- For project professionals, we will discuss enterprise and localised good practice for MES/Automation program/projects.
