About Us

Committed to improving research and development productivity for organizations around the world through better science and technology.

BIOVIA Discoverant Webinars

BIOVIA Discoverant enables operational excellence by connecting lab-to-plant workflows and information across the innovation and commercialization life cycle—delivering up to 10x reduction in batch deviation risk, 25% productivity improvement, 50% decrease in cycle times, 15% increase in process yields and 90% reduction in Annual Product Review preparation time. Components of the suite are used by 9 of the top 10 pharmaceutical companies to deliver transformational change in development and compliant operations.

Webinars will continue to be added to this series, so please check back often.

Past Webinars

Title and Speaker

New Capabilities of BIOVIA Discoverant 2017
Karri Unruh, PMP, CSPO Sr. Product Manager, Discoverant Dassault Systèmes BIOVIA
Larry R. Fiegland, Ph.D. Lead Field Application Scientist , Discoverant Dassault Systèmes BIOVIA

The latest release of BIOVIA Discoverant, version 2017, is now available with enhanced capabilities for proportional genealogy mapping, non-linear stability analysis and more. Join us for an overview of new features, including:

  • Calculation of weighted averages based on input contribution
  • Using quadratic and cubic methods to determine expiration ages based on stability study results
  • Making use of derived replicate parameters
  • Scheduling updates to merged Analysis Groups
… and much more!

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Upgrade Considerations for BIOVIA Discoverant 2017
Karri Unruh, PMP, CSPO Sr. Product Manager, Discoverant Dassault Systèmes BIOVIA

The latest release of BIOVIA Discoverant, version 2017, is now available. Join us for a discussion about items to consider when planning an upgrade, including:

  • Updating data models to take advantage of proportional genealogy mapping
  • Adding derived replicate parameters to your repertoire
  • Changes to job scheduling, including RESTful triggers
  • Importing HVU data from a spreadsheet
… and much more!

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New Deployment Options with BIOVIA Discoverant 2017
Karri Unruh, PMP, CSPO Sr. Product Manager, Discoverant Dassault Systèmes BIOVIA

With the daily demand for BIOVIA Discoverant analysis, alerting, and reports in global deployments, it is not uncommon for Analysis Group processing to occur around the clock. Join us for a discussion on different ways to deploy BIOVIA Discoverant for 24x7 processing with minimal impact to end-user interactive performance. Topics include new options available in the 2017 release and tuning the BIOVIA Discoverant services for maximum efficiency.

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Why Apply Non-Linear Regression for your Stability Data?
Ron Ortiz, Director, Manufacturing Science & Technology Pacira Pharmaceuticals
Larry R. Fiegland, Ph.D., Lead Field Application Scientist DASSAULT SYSTEMES BIOVIA

When evaluating the active pharmaceutical ingredient (API) or drug product stability under various environmental conditions, classical stability studies typically show linear degradation over time.

Many biological molecules or molecules with complex structures do not follow linear trends. According to the ICH Q1E Section 2.6 (Evaluation for Stability Data):

    “Regression analysis is considered an appropriate approach to evaluating the stability data for a quantitative attribute and establishing a retest period or shelf life.

    The nature of the relationship between an attribute and time will determine whether data should be transformed for linear regression analysis. The relationship can be represented by a linear or non-linear function on an arithmetic or logarithmic scale. In some cases, a non-linear regression can better reflect the true relationship.”

Since the guidelines allow for non-linear modelling in stability studies, when is it appropriate to use these methods? What techniques are available for these types of analysis? This talk will focus on answering these questions and will include a demonstration of non-linear analysis using BIOVIA’s Discoverant Stability Module within InVision.

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Implementing a Scalable CPV Program for Contract Manufacturing Organizations
Kate Lusczakoski, Director of Value Engineering

Continued Process Verification (CPV) is the monitoring of processes subsequent to validation in a continued manner throughout the lifetime of the product to ensure the process remains in control and meets the requirements set for the product. As many organizations know from experience, developing a scalable CPV monitoring program that enables sponsors and CMOs to collaboratively optimize their supply chain can be nearly impossible without the right tools.

Join us to learn about successful CPV monitoring components and how to minimize your implementation effort and obtain critical process improvement information. We will discuss designing for scalability to achieve a higher level of CPV monitoring maturity, lessons learned from BIOVIA customers and provide resources to move your CPV initiative forward. Attendees will also be provided with the knowledge and resources to evaluate their company’s level of CPV maturity.

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Best Practices for Transitioning from PI Module to PI AF/EF in Discoverant
Karri Unruh, Sr. Product Manager, Discoverant Suite

Intended for hierarchy developers and technical administrators, this session provides a look at how Discoverant works with OSISoft’s PI AF/EF database using the new Direct Connect to PI AF introduced in version 4.3 SP3. Topics include a comparison of the new PI AF views with the views available in the existing Direct Connect to PI; an overview of the configuration and new tester available in DCA; and recommendations for configuring hierarchies to provide a seamless transition for your end users.

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Delivering Business Value from your Process and Quality Data
Justin Neway, Ph.D., Senior Fellow
Brent Rognlie, Advisory Field Applications Scientist

In today's pharmaceutical manufacturing industry, there are major challenges with getting the data you need from all the disparate sources and paper records across the organization in order to make business decisions. Then when you get the data, it requires error-prone manual work to analyze and generate reports. Working in spreadsheets, dealing with the delay of getting the additional data needed and using un-validated analysis results and reports are all major problems that people face every day. This costs organizations time, resources and ultimately, money.

This webinar will show you how:

  • Improving process outcomes by identifying sources of process variability results in improved process control
  • Improving process performance visibility with automated trending and alerts for review-by-exception can enable preemptive action
  • Providing on-demand data access, aggregation and contextualization will reduce non-value-adding manual tasks and the risk of errors
  • Role-based signal monitoring dashboards improves process performance visibility across the production enterprise

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Signal Monitoring Dashboards, Graphical Mapping of Process Genealogy and More with Discoverant 5.0
Karri Unruh Sr. Product Manager and Larry Fiegland, Lead Field Apps Scientist

The latest release of BIOVIA Discoverant, version 5.0 is now available. Featuring new enhancements including capabilities for advanced monitoring and collaboration that empowers process production operations and maximizes opportunities to improve process variability and sustainability.

BIOVIA Discoverant's new features enhance the data-driven decision making ability while helping manufacturers improve the quality and economics of their operations by identifying, reducing and controlling sources of variability while maximizing desirable process outcomes.

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You Can be Best Friends with Your Process Data Using the Discoverant Operations Intelligence System
Justin Neway, Ph.D., Senior Fellow
Brent Rognlie, Advisory Field Applications Scientist

Just because you can capture your process data doesn’t mean it’s easy to use. It’s usually locked in databases, data historians and paper records meaning you waste time getting access to it or waiting for someone else to get it for you. When you finally have your data, it needs to be organized before it can be analyzed meaning more hours of error-prone manual spreadsheet work. More time is wasted with second person verification if you need to make GMP decisions based on your data analysis results.

This presentation will demonstrate how Discoverant solves the need for a live, self-service connection from your desktop to all your process data without needing changes to your existing databases and paper record systems. You will also see how all the data organization is done automatically on the fly, including process genealogy, so you can easily do upstream / downstream correlations that take splitting and pooling of the process stream automatically into account.

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How Process Management Informatics Supports ICH Q8, Q9, Q10, Q11 and Continuous Process Verification
Justin Neway, Ph.D., Vp & Chief Science Officer, BIOVIA

Process Management Informatics is defined as the technology and systems needed to design, commercialize and sustain robust manufacturing processes that give predictable, high quality outcomes cost-effectively, based on scientific process understanding. This presentation will show how the principles outlined in the ICH Q8, Q9, Q10, Q11 and FDA Validation guidance can be satisfied by using a Process Intelligence system that provides collaborative, on-demand data access, aggregation, contextualization, analytics and reporting platform that spans local and geographically remote process development, manufacturing and quality assurance organizations..

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What’s New in BIOVIA Discoverant 4.3
Karri Unruh, Sr. Product Manager, BIOVIA

In this webinar we will discuss and demonstrate the new features found in the latest version of BIOVIA Discoverant, the industry-leading Process Management Informatics application. This release offers significant Stability and Expiration Dating enhancements and other new capabilities that improve the ability of life sciences manufacturers and process development organizations to analyze and make decisions based on product stability test results.

Join us to learn about the new Stability OOT Alerting tool, alerting in Stability Pooling and Dating, and much more.

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