The theme for the 2021 ISPE Annual Meeting & Expo is: “Agility. Collaboration. Innovation.”, and that is tied in well to the importance of Information Systems for our industry. There is more need than ever to emphasize the need for agility to adapt to changes, the need for collaboration to coordinate those changes, and innovation to facilitate those changes to the digitalization model. These have allowed pharma to realize that operational excellence is the basis for constant change and the best environment to sustain continuous improvement for advancements in global digitalization.
The Information Systems Track will have focused sessions around the GAMP® supported foundation and ISPE Pharma 4.0™ Operating Model. As part of this track, we will introduce the approach of the new “GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, and IT Service Management” that is planned to be available just before the Annual Meeting. Evolving regulatory changes and industry changes require the evolution of guidance and systems. The Information Systems Track will cover GAMP® principles, Machine Learning (ML) / Artificial Intelligence (AI), lifecycle management, Pharma 4.0™, and Blockchain, evolving rapidly in alignment with the new industry trends. The Information Systems Track will also detail practical application of the trends in case studies.
This is an overview of the sessions in the Information Systems Track:
Digital Innovation: Ensuring Quality and Regulatory Compliant Solutions.
From a newly formed GAMP® 5 framework to computer systems/software assurance for automation, this session provides easily understandable and practical approaches behind the “mystery” of compliance for such novel digital technologies. Computer Software Assurance (CSA) focuses on critical thinking and testing/assurance instead of documentation by streamlining the validation efforts based on the integral risks to the product quality, patient safety, and data integrity. It will also describe a life cycle framework for Machine Learning (ML) for use within life sciences in a GxP regulated environment.
GAMP® 5: Agile Methods, Critical Thinking, and IT Infrastructure Control
This session will focus on how the GAMP® 5 model is evolving to adapt to digitalization changes. Understanding the flexibility of GAMP® 5, that Agile demonstrates control and how records or tools can be used in place of documentation. Critical Thinking is a mindset that must be applied when implementing GAMP® 5 to ensure that a risk-based approach to quality and compliance takes account of the multiple layers of assurance that may exist upstream or downstream of the system within the business process it supports. The use of Good IT Practices, electronic IT Service Management Tools, and Automation as an effective means of achieving continuous compliance of the IT infrastructure environment, including cloud and on premise.
Lifecycle Management and Modernization
The focus of this session will be on the implementation of modern computerized systems in the pharmaceutical industry. The presentations in this session will provide insight on how to approach implementing your own specific computerized system strategies through critical thinking and risk analysis. After participating in this session, you will have a better understanding of how to practically modernize software compliance methods for computerized systems in the future.
Elements of Digitalization in the Pharma 4.0™ Journey
The session will examine the components required as the industry progresses towards implementing the Pharma 4.0™ concept, where The digitization of processes and methodologies drives manufacturing. The speakers will explore various aspects required in the realization of a Pharma 4.0™ enabled facility, including the building of digital solutions in a GMP environment, the digitization of SOPs, the elimination of paper and data capture to produce a digital batch record. We will hear a case study that provides insight into the delivery of data as a validation package and the benefits that will transform the validation efforts moving forward. Within the context of Pharma 4.0™, we will also review the function of the operator in this new environment and how their role will change from one of system monitoring to the role of contributor and collaborator and the tools required to achieve this paradigm shift.
Trends and Use Cases for Blockchain in Pharma Supply Chain
The application of blockchain technology to help the medical supply chain become more secure and resilient is increasingly gaining more traction in our industry. During this session, we will hear how blockchain can improve science and accelerate medical research while bringing a new layer of trust to healthcare. Follow major milestones that have been achieved thus far and describe how blockchain is being used to facilitate the verification of saleable returns. Using a blockchain for plasma derived therapies brings a level of trust and transparency to our regulators.
Check out the 2021 ISPE Annual Meeting & Expo to get a glimpse of what we have in store and we hope to see you there.
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