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The afternoon will begin with a plenary discussion, featuring a number of industry experts, about the upcoming draft Computer Software Assurance draft guidance from FDA’s CDRH division This is widely envisaged as a mandate from FDA to rigorously apply risk management to computer validation activities, and designing ‘right size” assurance that software used to support quality decisions can be relied on, while encouraging innovation and optimization of computer software solutions.
The afternoon will split into two parallel tracks; One will focus on validation of software, how to design a risk based approach, best practices to audit Software as a Service providers, and practical examples of validating SaaS solutions in a regulated environment.
The second track will examine new technologies and how they might be advantageous in Life Science companies. Sessions will include an introduction to Artificial Intelligence and Machine Learning to cover what it is, what it is not, and how to approach leveraging it in regulated environments. Complimenting this, you will have the opportunity to understand the core concepts of blockchain technologies, such as the role and needs for distributed ledgers, and hear practical use cases and lessons learned from industry projects. This track session will conclude with some live demos and online tools to help visualize both these concepts.
Plenary Session: Computer Software Assurance: Paradigm Shift: In an effort to harmonize
with international standards, the FDA (CDRH) announced in their FY 2019
Proposed Guidance Development list to release a new draft guidance “Computer
Software Assurance for Manufacturing, Operations, and Quality System Software,”
that aligns with the current quality systems regulation ISO 13485. Hear
directly from members of the FDA/industry collaborative team on the scope of
what this guidance may entail and from individuals who have already implemented
the FDA’s proposals.
The Use and Compliance of Artificial Intelligence (AI) in the Pharma/Biotech Industry The pharma/biotech industry
is increasingly relying on software to automate many functions previously
performed by humans. As our computer systems become more integrated and data
sets become more robust, computer science is advancing our ability to learn
from that data and draw conclusions about what might, or should happen next. We
are now reaching a point where these algorithms are sophisticated enough to
begin making decisions for us in the form or artificial intelligence (AI). This
presentation will highlight how AI is being used in industry and how/what
companies are doing to ensure its compliance with predicate rule and the latest
regulatory guidance on data integrity (DI).
CSV 101: Just What Does "Risk Based" CSV Mean? Whether new to computer system validation or
a seasoned validation professional this presentation will provide insight on
the importance of applying a risk based approach to computer system lifecycle
activities by appropriately scaling activities and deliverables.
For years, GAMP® and regulatory guidance have
emphasized the need to scale all lifecycle activities and the associated
documentation according to risk. The risk based approach should take into
account data integrity, product quality, and patient safety. While many
companies say they have a risk based approach, often risk is not effectively
identified or managed throughout the system and data lifecycles. It is
important, therefore, to think, both logically and critically, about the
potential risks to the business processes, the system, and the data to
effectively identify, mitigate, and control risk.
Blockchain Applications in Pharma Blockchain technology is
beginning to take hold in Life Sciences; there are a number of successful
pilots and several production solutions that address industry issues ranging
from DSCSA Saleable Returns to Clinical Trial Management. This session
will introduce the core concepts of blockchain technologies and share practical
use cases/lessons learned from industry projects.
Compliant Computer System Validation in an "as-a-Service" World The presentation will discuss the growing landscape
of SaaS applications available and in use in pharma and the challenges
associated with those. We will review
key differences in implementing, validating, operating, and managing hosted
applications and the vendors that sell them, from setting up a system
development life cycle program, to understanding the importance of vendor
qualification, to testing, to setting up appropriate operational controls, like
risk-based change management and periodic review. We will discuss the
differences between traditional on-premise systems validation as opposed to the
needs of hosted system qualification.
Auditing XaaS Suppliers for GxP Applications Cloud delivered GxP applications are rapidly
replacing locally deployed applications as the norm. This presentation will
focus on the questions to ask and technical considerations for engaging XaaS
providers to ensure high performance and fully compliant service delivery.