MasterControl makes it easy to gather data, but you'll need to know how to properly analyze that data to unlock its full potential. Join us for a demonstration of our new Insights tool and learn how to navigate standard reports, visualizations, and dashboards, plus how to build your own custom reports and visualizations to meet your specific needs. This session is for MasterControl cloud users who already have a basic understanding of the system. Please note, those interested in MasterControl Analytics should attend “Mastering Documents and Training With JReports” instead.

The Hackathon is your opportunity to change the future of MasterControl! Come grab a drink, enjoy some hors d'oeuvres, and join with other users to submit new enhancement ideas for the MasterControl platform. Our dedicated team of hackers will have the most popular suggestion ready to demo by the end of Masters Summit.

The Next Frontier is Here: Jon Beckstrand, Chief Executive Officer; MasterControl

• Sue Marchant, Executive Vice President of Product; MasterControl
• Kevin Rodriguez, Manager, eQuality Systems; BioBridge Global
• Matt Seitz-Paquette, North America Quality Specialist; Fagron
• Adara Leonard, Quality Systems and Compliance Supervisor; Fagron

Dr. Neil deGrasse Tyson, American Astrophysicist and Science Communicator

Hackathon Selection Show: Matt Lowe, Chief Strategy Officer; MasterControl with Ryan Castro, Director Engineering; MasterControl

Every regulatory body has requirements concerning risk. If you want to be prepared to meet them, you need to understand how hazard, harm, and severity are used to measure potential risk. Join us as we explore what you need to know when working toward compliance with ISO 14971 and similar standards. Attendees will learn how to enhance the quality of risk-based thinking by making analysis more visible, improving communication and teamwork, and using facts and data effectively. This session is for product and project team members looking to improve how they find, prevent, and manage risk.

Disconnected business sites can create organization-wide inefficiencies. Join us to learn how to achieve end-to-end harmonization of the complete suite of MasterControl products to unlock greater productivity in your quality and regulatory operations and beyond. Attendees will also discuss leveraging multi-system integrations like ERP and HR within MasterControl to reduce redundancies and streamline processes. This session is recommended for managers.

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking. 

If your digital documents aren't easily searchable, they're no better than paper. Join us to see how Botable uses artificial intelligence to search your quality documents and records from directly within MasterControl, providing detailed and accurate responses to quality-related queries. No previous experience with AI is necessary! This session is recommended for those looking to improve the productivity and efficiency of their document searches.

More than 90% of the industry is either non-digital or under-digitized. Join us and learn how MasterControl Manufacturing Excellence has been purpose-built to address the rapidly evolving needs of the pharmaceutical and medtech spaces. You'll learn how MasterControl is redefining manufacturing execution and be the first to see what's planned for the platform over the next four years. This session is for MasterControl Quality Excellence users considering expanding to Manufacturing Excellence or current Manufacturing Excellence users wanting to see what's next.

Even the most experienced quality professionals face challenges like deviations, investigations, and corrective actions/preventive actions (CAPAs) when bringing safe and effective products to market. A well-designed quality management system can help you more effectively navigate a deviation from initiation all the way to remediation. Join us as we explore how to manage this process, the appropriate use of root cause analysis (RCA) tools, and how to eliminate deviations and improve manufacturing compliance through appropriate CAPAs. This session is for anyone looking for tools to improve their quality investigations.

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking.

A proper understanding of your assembly line is key to effective manufacturing. Join us to learn more about how you can use run charts and kaizen process mapping to spearhead process audits that offer insight into your processes, identify opportunities for improvement, and increase success and profitability at your organization. Attendees will learn how to unlock a better understanding of their quality control processes so they can ensure their products meet the absolute highest standards of quality. This session is for anyone looking to improve process audits at their organization.

MasterControl's Quality Excellence and Manufacturing Excellence are powerful tools on their own, but they need to be combined to unlock their full potential. Come learn how you can combine these two solutions to seamlessly integrate your documents, training requirements, and quality events with your electronic production records. Attendees will see how Fagron's North America Quality Specialist Matt Seitz-Paquette integrated the two systems and the benefits Fagron has enjoyed since doing so. This session is for those looking for better unity between their quality and manufacturing operations.

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking. 

MasterControl's patented Validation Excellence tool (VxT) was years ahead of the FDA's recent guidance on risk-based validation. And now MasterControl is once again changing the face of validation with Validation on Demand (VoD). Join us as we demonstrate how this new innovation empowers customers to ensure validation for their own unique processes. Attendees will see VoD in action, learn how it aligns with FDA guidance, and see how it builds on the industry-leading innovation that began with VxT. This session is for any current or potential MasterControl Quality Excellence user interested in faster, easier validation.

Integrations are essential for connecting outside equipment and services to your MasterControl solution. Join us as we demonstrate how MasterControl works to streamline integrations and how you can use MasterControl's out-of-the-box tagging to easily connect MasterControl Manufacturing Excellence to key equipment and tools. This session is for anyone looking to leverage integrations at their company.

Join this informative session where we will be discussing new ideas for continuous improvement practices, the rise of advanced therapies and small batch manufacturing, practical ways to incorporate AI into your functions and what quality and manufacturing roles of the future will entail. Moderated by MasterControl’s senior director of PR and Content, Jennifer Sefakis, this session is for those wanting to stay up to date on the latest trends in the industry. Attendees will learn how the industry is changing and how to leverage those changes and remain competitive.

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking. 

The Next Gen QMS – From Documents to Data: Heike Roeder, VP Global Quality Assurance International; Cencora

The Future Is Flexible: No Code. No Tradeoffs. No Limits: Alex Kaplunov, Chief Technology Officer; MasterControl with Sue Marchant, Executive Vice President of Product; MasterControl

The Next Frontier: Advanced Quality Event Management in Action: Sue Marchant, Executive Vice President of Product; MasterControl with Patricia Santos-Serrao, Senior Director, Product Management; MasterControl

10 Talk: Orchestrating a Divisional Quality Management System With Project Symphony: Pravin Betala, Sr. Principal Quality Systems Engineer; Stryker

Elevating Customer Experience For A Digital World: Kiran Dhanuka, Chief Customer Officer; MasterControl

• Emmanuel Casasola, Executive Director, Global Quality; BioBridge Global
• Lori Jackson, Senior Director, Quality; PCI Pharma Services

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking. 

If your digital documents aren't easily searchable, they're no better than paper. Join us to see how Botable uses artificial intelligence to search your quality documents and records from directly within MasterControl, providing detailed and accurate responses to quality-related queries. No previous experience with AI is necessary! This session is recommended for those looking to improve the productivity and efficiency of their document searches.

MasterControl's upcoming no-code logbook builder is simple to use and powerful to behold. Join us as we explore what MasterControl Logbooks is and how to set up, launch, and use this new MasterControl solution. This session is for anyone interested in learning more about using logbooks with MasterControl.

A proactive approach to digital maturity helps to ensure efficiency, intelligence, and a competitive edge. And it starts with making data-driven decisions. Join us for a breakdown of why this needs to be a high priority for your organization and how MasterControl can help get you there. Attendees will learn more about recent MasterControl Insights upgrades as well as what’s next on the MasterControl roadmap and how artificial intelligence can help you further optimize processes. This session is for any current or potential MasterControl Quality Excellence or Manufacturing Excellence user looking to take a more proactive approach to their processes.

Effective quality requires the cooperation of every department, but quality professionals know that explaining the role and impact of quality to others at their organization can be a challenge. Join us to learn how BioBridge Global has fostered a culture of quality through five simple words that convey what it means to be a quality professional and the role quality plays in the company's mission to save and enhance lives through the healing power of human cells and tissue. This session is for quality managers looking to improve their organization's relationship with quality.

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking.

If your digital documents aren't easily searchable, they're no better than paper. Join us to see how Botable uses artificial intelligence to search your quality documents and records from directly within MasterControl, providing detailed and accurate responses to quality-related queries. No previous experience with AI is necessary! This session is recommended for those looking to improve the productivity and efficiency of their document searches.

At best, a quality management system (QMS) lacking in visibility isn't reaching its full potential. At worst, it can cause serious ramifications for your organization. Join us as we explore the ways unstructured data prevents teams from accessing insight into the performance of their QMS. Attendees will learn techniques that will help them eliminate data silos and more effectively use the data they have. This session is for those looking to improve the way their business collects and captures data.

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking.  TEST

Quality is critical for regulatory compliance. Sadly, that doesn't mean the importance of quality is always understood by executives. Join as we share how to make the business case for quality to your executive team. Attendees will learn how to explain the return on investment offered by a quality management system or manufacturing execution system, the key things executives will look for in your proposal, and how to ensure leadership is able to access data that will better inform the decisions they make regarding budgets and priorities. This session is for quality managers, directors, and sysadmins hoping to find more support from their C-suite.

MasterControl products and modules work together for efficient, big-picture quality that automates processes, connects data, and provides a seamless experience for users, administrators, and regulators alike. Join us to learn more about how our connected system unifies processes and how we’re continuing to improve this system through new features like advanced quality event management (AQEM). This session is for those interested in learning more about how MasterControl products work together to increase efficiency and automate quality.

An optimized, error-free, and seamlessly connected manufacturing operation is a competitive necessity. Join us to learn Aspire Pharmaceuticals' strategy for leveraging MasterControl and Elemental Machines to capture equipment and environmental data and seamlessly incorporate it into electronic batch records. Attendees will learn how to proactively identify issues, reduce batch errors, and leverage unified data. This session is for anyone looking to use digitization to improve efficiency and unify data across systems.

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking.

MasterControl's patented Validation Excellence tool (VxT) was years ahead of the FDA's recent guidance on risk-based validation. And now MasterControl is once again changing the face of validation with Validation on Demand (VoD). Join us as we demonstrate how this new innovation empowers customers to ensure validation for their own unique processes. Attendees will see VoD in action, learn how it aligns with FDA guidance, and see how it builds on the industry-leading innovation that began with VxT. This session is for any current or potential MasterControl Quality Excellence user interested in faster, easier validation.

A system needs to be compliant, flexible, user-friendly, and resource-light to be successful. Join us to learn how Denali is accomplishing all this by going paperless. Attendees will learn how Denali leans on MasterControl's best practices to quickly deploy MasterControl's Manufacturing Excellence and Quality Excellence solutions and how they embrace off-the-shelf solutions while building a new and innovative facility. This session is for those early in their digital journey looking to make the most of this new digital frontier.

Join Stryker Medical’s Quality Systems/Integration Team member Pravin Betala to understand how the company is evolving from seven different quality management systems (QMS) into a single scalable, flexible, and collaborative quality system. Stryker Medical’s multi-year initiative, Project Symphony, is orchestrating and reimagining quality management at the organizational level. This session is for anyone looking to learn techniques and perspectives to consolidate, improve, and scale a QMS.

Data Driven Performance in the Fast Lane: Mark Gallagher, Guest Keynote; Formula 1 Executive

10 Talk: Entering a New Frontier of Smart Productivity: Matt Lowe, Chief Strategy Officer; MasterControl

Masters of Excellence Awards: Jon Beckstrand, Chief Executive Officer; MasterControl with Alicia Garcia, Chief People & Culture Officer; MasterControl

10 Talk: Mapping the Next Frontier: Dave Edwards, Chief Revenue Officer; MasterControl

Hackathon Reveal: Matt Lowe, Chief Strategy Officer; MasterControl with Ryan Castro, Director Engineering; MasterControl

The ability to capture, analyze, and reuse all layers of manufacturing process data provided an exciting opportunity to Pfizer in its manufacture of investigational biotherapeutics. Join us to learn how Pfizer advanced their digital transformation by deploying MasterControl Manufacturing Excellence across nine distinct manufacturing groups. The Pfizer team will share the value drivers of their digital transformation, the lessons they learned during a multi-site deployment, and key next-generation use cases. This session is for anyone interested in how to deploy electronic batch records in GMP manufacturing.

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking.

Every regulatory body has requirements concerning risk. If you want to be prepared to meet them, you need to understand how hazard, harm, and severity are used to measure potential risk. Join us as we explore what you need to know when working toward compliance with ISO 14971 and similar standards. Attendees will learn how to enhance the quality of risk-based thinking by making analysis more visible, improving communication and teamwork, and using facts and data effectively. This session is for product and project team members looking to improve how they find, prevent, and manage risk.

Looking to grow your network? Catch up with colleagues? Or just want a chance to grab a drink and chat with other professionals? You’re not going to want to miss Summit Connect. Join us for an organized half hour of talking shop, talking strategies, and talking life with your peers. No other speakers or activities – just networking. 

Advanced Quality Event Management (AQEM) is almost here! And we're here to help you make the most of it. Join us as we navigate the basics of designing and configuring your forms in AQEM, focusing specifically on capturing the right data for each type of event. You'll learn how to build workflows, assign users, and keep your system running smoothly. This session is for early adopters of the Advanced Quality Event Management tool.

Advanced Quality Event Management (AQEM) is almost here! And we're here to help you make the most of it. Join us as we navigate the basics of designing and configuring your forms in AQEM, focusing specifically on capturing the right data for each type of event. You'll learn how to build workflows, assign users, and keep your system running smoothly. This session is for early adopters of the Advanced Quality Event Management tool.