Revolutioning Patient Outcomes through Data and Analytics         5.4.23

Our CEO, Kathleen Brunner, shares her experience and expertise on data, healthcare, and the impact technology has on all of us with the faculty, students, alumni, and guests of Capella University.
Her presentation provides a look at data and analytics in the life sciences and the resulting technological advancements, such as artificial intelligence, machine learning, and natural language processing. She delves into the challenges and opportunities they present, with a focus on how data and analytics revolutionize patient care and accelerate better outcomes.

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Application and Data Integration for GxP Applications 7.11.23


The webinar, led by Acumen's George Brunner and Kneat's Sal Papparone, provided a comprehensive overview of data integration and digital validation in GxP-regulated industries. It began with an introduction to GxP regulations and their critical role in ensuring data integrity, compliance, and quality. The session highlighted the complexities and benefits of integrating data from diverse sources and the essential processes involved, such as data collection, mapping, transformation, and integration. Key insights were shared on digital validation principles and regulatory requirements, including the importance of audit trails and documentation. The discussion was enriched with case studies demonstrating practical applications in quality management and pharmaceutical manufacturing. The webinar concluded with best practices for data integration and validation, emphasizing the significance of training, documentation, and adherence to regulatory compliance, setting the stage for future advancements in Pharma 4.0 and Manufacturing 4.0.

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Technical Tuesday: Amplifying Your Digital Validation Implementation With Integration                                        7.18.23

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In the Tech Tuesday webinar presentation on July 18, 2023, by George Brunner, Chief Digital Officer at Acumen Analytics, Inc., the focus was on amplifying digital validation implementation through integration in GxP (Good x Practice) applications. The presentation covered the importance of GxP, explored data integration and digital validation, and featured use cases in Pharma Quality Management and Medical Device Manufacturing. Discussions included the positive impact of integration and validation technologies on sustainability in GxP, along with insights into best practices for ensuring data integrity, compliance, and quality. The integration process and associated challenges were outlined, accompanied by case studies on integrating Quality Management Systems (QMS) and Digital Validation Applications in pharmaceutical companies, as well as Manufacturing Execution Systems (MES) and Digital Validation Applications in medical device companies. The presentation also delved into future opportunities in the integration and validation landscape for GxP applications, concluding with a dedicated Q&A session for participant engagement. The overarching theme highlighted the benefits and challenges of integrating diverse data sources in GxP environments into digital validation applications, emphasizing the importance of maintaining data integrity, compliance, and quality while exploring sustainable practices and future advancements.

Navigating GXP Compliance 9.21.23

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The webinar, "Navigating GxP Compliance Through Integrated AI Applications," features co-presenters Toni Manzano, co-founder, and CSO of Aizon, and George Brunner, Chief Digital Officer at Acumen Analytics. Aizon, specializing in Pharma 4.0, enables the pharmaceutical and biotech industries to embrace Smart Manufacturing. George Brunner, representing Acumen Analytics, a leader in leveraging data and advanced analytics for life sciences transformation, shares insights into integrated AI applications.
The presentation explores the definition of artificial intelligence, its application in life sciences, and AI workflows, with an emphasis on the critical role of data. Real-world examples illustrate the practical value of integrated AI applications in addressing challenges such as yield improvement. Topics include understanding AI, data preparation, required data quality, and AI in action with cases like Root Cause Analysis in OEE and improving Packaging Line OEE. The webinar also highlights the use of Digital Twin technology for enhanced insights and efficiency. Business challenges, such as a continuous decrease in yield, are addressed through AI consulting services, showcasing tangible results in improving overall process variance and yield. The webinar provides valuable insights into the strategic use of integrated AI for navigating GxP compliance in the pharmaceutical industry

Establishing Data Governance within the Digital Validation Sector 10.29.23

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The recent roundtable event focused on the evolving landscape of digitization and data governance in validation. Key speakers, including Dave O'Connor and George Brunner, examined the current state of digitization, emphasizing the need for robust data governance to ensure accuracy, security, and compliance. A significant portion of the discussion revolved around lessons from other industries, such as banking, highlighting the impact of open banking on fostering competition and innovation. The event also touched upon the latest guidance in data governance, referencing the Good Practice Guide in development by ISPE. This guide aims to facilitate innovation, efficiency, and cost-saving through concepts like governance across organizations and data democratization. The event concluded with a forward-looking plenary session, discussing potential future changes in the field and the industry’s direction in the next five years.

Establishing Data Governance within the Digital Validation Sector Recording