Salt Lake City, UT
// 14-18 October
// Hyatt Regency

Join us at our can’t-miss event for Quality and Manufacturing professionals in life sciences and beyond.

Mon. / Oct. 14

Day 1

7:00 AM - 8:00 AM

Workshop Breakfast

8:00 AM - 5:00 PM

Audit and Supplier Crash Course

Workshop

Optional
The Audit and Supplier modules are powerful tools, but they're at their best when they work together. Join us for an in-depth overview of both modules and the specific ways in which they interact. This session is for any MasterControl user looking to improve their experience with the Audit and Supplier modules.

PRESENTED BY

Jared Evans

Learning Implementation Manager

MasterControl

8:00 AM - 5:00 PM

Building and Using Master Templates

Workshop

Optional
Proper documentation is crucial to maintaining your production records, but a poorly designed template can be as unhelpful as no template at all. This workshop will explore ways to ensure templates are properly designed so you can confidently create templates knowing they'll be efficient, accurate, and accessible to your employees. Attend this workshop if you'd like to get more out of your templates when using the production records module.

PRESENTED BY

Sue Echavarria

Senior Professional Service Consultant

MasterControl

8:00 AM - 5:00 PM

Everything AQEM: Improving Processes, Creating Forms, and Connecting Products

Workshop

OptionalSOLD OUT

Advanced Quality Event Management (AQEM) is a powerful tool that simplifies the way you manage quality events. Join us for a day-long session for everything AQEM, including defining your ideal processes, understanding the basics of AQEM, and connections available with other MasterControl products. You’ll learn how to: 1) Accurately map a process end-to-end while identifying ownership, intersection points, dependencies, desired outcomes, and industry best practices. 2) Build forms and workflows, assigning users, and validate your processes. 3) Understand available cross functionality with other MasterControl products like Documents and Production Records. This session is ideal for new users of AQEM and those who want to maximize their current use of the tool.

PRESENTED BY

Randy Jensen

MasterControl

Candace Hagood

Sr. Professional Services Manager North America

MasterControl

8:00 AM - 5:00 PM

Quick Solutions to Slow Problems

Workshop

Optional
A working knowledge of a system is not always enough knowledge to troubleshoot issues in that system. This hands-on workshop will explore the most common issues encountered by MasterControl users and how to identify, diagnose, and resolve these issues, leaving you with the skills to do the same in your own MasterControl environment. This workshop is for those wanting to gain a better understanding of how to troubleshoot their MasterControl system.

PRESENTED BY

Ryan Jones

Manager, Learning Consulting

MasterControl

8:00 AM - 5:00 PM

Surprise, You're a SysAdmin

Workshop

Optional
What is a new MasterControl sysadmin to do when they suddenly find themselves responsible for managing and maintaining the application and training its users? Join us as we explore how the pieces of your MasterControl system are interconnected and how to use them in your new position. This session is best for new sysadmins who already have a working knowledge of life cycles, InfoCard metadata, roles, and collaboration.

PRESENTED BY

Jacob Russo

Learning Experience Designer

MasterControl

8:00 AM - 5:00 PM

Surprise, You’re a Training Coordinator

Workshop

Optional
Are you a new MasterControl training coordinator still acclimating to your position? Join us as we explore the basic responsibilities of a training coordinator and how to navigate and make the most of the training module. Attendees will learn how to assign training, track courses, run reports, and ensure their system runs smoothly and efficiently. This session is designed for newer MasterControl training coordinators looking to improve their confidence in their position.

PRESENTED BY

Stephanie Marshburn

Learning Consultant

MasterControl

8:00 AM - 5:00 PM

Unlocking Your Data With MasterControl Insights

Workshop

OptionalSOLD OUT
MasterControl makes it easy to gather data, but you need to know how to properly analyze that data to unlock its full potential. Join us for a demonstration of the MasterControl Insights tool and how you can use it to navigate visualization, dashboards, and standard reports. Attendees will also learn how to build custom reports and visualizations to best meet their organization's specific needs. This session is for MasterControl cloud users with a basic understanding of the system.

PRESENTED BY

Jodi Jarrett

Senior Product Manager - Insights

MasterControl

12:00 PM - 1:00 PM

Workshop Lunch

5:00 PM - 6:00 PM

Partner Happy Hour- An Invitation Only Event

We are pleased to invite you to a private welcome reception exclusively for MasterControl partners and our leadership and partner team members.

Join us for an evening of connection and collaboration, complete with beverages and appetizers. Afterward, we will head directly to the Hackathon Reception for more exciting opportunities to network. We look forward to celebrating with you!

6:30 PM - 8:00 PM

Hackathon Reception

Don’t miss our big Summit kickoff event Monday evening at the Hyatt. The Hackathon is where you tell us the features and functionality you’d like to see in MasterControl. The top ideas will make it into the Hackathon bracket, where the winning idea will be coded into the software by the end of the week! This year you'll be submitting your ideas digitally – helping us save a little time and a whole lot of paper. It’ll also help us keep ideas that don’t make it through the big bracket in consideration for future MasterControl updates. Whether you have 1 idea or 100, be sure to join us for a drink, a few bites, and a whole lot of fun catching up with your friends and colleagues.  

PRESENTED BY

Alicia Garcia

Chief People and Culture Officer

MasterControl

Erin Wright

Vice President, Product Management

MasterControl

Ryan Castro

Vice President, Engineering

MasterControl, inc.

Tues. / Oct. 15

Day 2

8:30 AM - 10:00 AM

Keynote Sessions

Wow. Now.: Jon Beckstrand and Jonathan Goldman, MD

Hackathon Selection Show: Erin Wright and Ryan Castro

The Black Box of Change: Tim McCleary

PRESENTED BY

Alicia Garcia

Chief People and Culture Officer

MasterControl

Jon Beckstrand

Chief Executive Officer

MasterControl

Jonathan Goldman

CEO

Clinical ink

Erin Wright

Vice President, Product Management

MasterControl

Ryan Castro

Vice President, Engineering

MasterControl, inc.

Tim McCleary

Founder & Managing Director

The Involvement Practice

10:00 AM - 10:30 AM

AM Break

10:30 AM - 11:15 AM

From Error to Excellence: Why Manufacturers Need to Embrace Digital Maturity

Business Leadership

Delve into the transformative journey 'From Error to Excellence'.  Explore how embracing digital maturity in pharmaceutical manufacturing can significantly enhance efficiency and return on investment (ROI). We will showcase innovative methods tailored to improve operational workflows. You'll learn how to unlock advanced features and functionalities to elevate your production processes with a MasterControl + Elemental Machines integration. This session is great for manufacturing professionals in the pharmaceutical industry. 

PRESENTED BY

Jennifer Rodriguez

Corporate Quality Systems Manager

QuVa Pharma

Dan Petkanas

Global Alliances Director

Elemental Machines

10:30 AM - 11:00 AM

Re-Think Your Processes with GxPAssist AI

Demo Theater

SOLD OUT

Artificial Intelligence (AI) is poised to significantly streamline processes for life-sciences professionals like you. See how GxPAssist AI tools from MasterControl are designed to deliver practical, powerful, compliant, and validated AI functionality to our customers in highly-regulated industries. Join us to learn more about our latest AI tools, like Exam Generator and Document Translator. Learn how they are designed to be low-risk, user-friendly applications that will help you automate manual tasks, improve efficiency, and save time. This session is great for any attendee who wants to learn more about how MasterControl is responsibly incorporating AI into our suite of solutions.

PRESENTED BY

Renee VonBergen

Director, Product Management, AI/ML

MasterControl

10:30 AM - 11:15 AM

The Keys to Simplifying Your Quality System

MC University 301

A needlessly complicated system leads to unnecessary inefficiency. And, no matter how you set things up initially, complexities can creep in over time. Join us as we reveal best practices and principles to help you reduce the number of workflows, simplify vaults, and streamline roles. We'll give you diagnostic tools to help you assess the efficiency of your system, and we'll show you how to build a plan to prevent these challenges from cropping up in the future. This session is great for any quality professional looking to boost efficiency.

PRESENTED BY

Ryan Jones

Manager, Learning Consulting

MasterControl

Jessica Jones

Manager, Content Curation

MasterControl

10:30 AM - 11:15 AM

Transforming Quality Management with AI

Real-World Voices

Harness the power of Artificial Intelligence (AI) to enhance efficiency and accuracy. Join Botable and MasterControl customer Berkshire Sterile Manufacturing (BSM) as they delve into proven, real-world applications of AI in quality management. See how they use AI to enhance document management, improve non-conformance resolution, and more. This session is great for quality professionals looking to integrate AI tools into their processes.

PRESENTED BY

Greg Waldstreicher

Chief Executive Officer

Botable.ai

Ryan DeChaine

QA Systems Specialist II

Berkshire Sterile Manufacturing

11:10 AM - 11:40 AM

Putting Generative AI to Work In Your Pharma Process

Demo Theater

What could you do with a generative AI tool that caters for the privacy and accuracy concerns for pharma use? Join the team from Veqtor to learn more about their NEXA tool. You’ll learn how this new tool takes user requirement specifications (URS) and the technical specifications for equipment, ingests that information, then generates a best-in-class test case for the requirements. You’ll see an interactive demo of the tool so you can evaluate the efficiencies it can bring to your organization. We’ll also discuss how it can help achieve validation 4.0 principles of real-time verification of integrations with other systems in the digital ecosystem. This session is great for manufacturing and quality professionals in the pharma industry.  

PRESENTED BY

Phil Jarvis

director of CQV and digital validation strategy

veqtor solutions

11:25 AM - 12:25 PM

Building Advanced Forms with Advanced QEM

MC University 401

You thought you enjoyed making forms before, but you had no idea how great it could be. Advanced Quality Event Managment (QEM) provides a flexible, user-friendly interface that makes it easy to build forms to track anything you need. We’ll walk you through the basics and dive deep into some of the most useful functionality. This session is great for any quality professional who wants to stay on top of their form-building game.

PRESENTED BY

Jacob Russo

Learning Experience Designer

MasterControl

Kris Peek

Sr. Learning Experience Designer

MasterControl

11:25 AM - 12:25 PM

MasterControl Logbooks Today and Into the Future

MC Innovation

MasterControl Logbooks launched in May 2024 to much excitement and fanfare, but we haven’t stopped there. Join us for a deep dive into newly released and upcoming products in the Manufacturing Excellence suite, including MasterControl Logbooks. Then see the exciting things we have in store for solutions like equipment management and inventory management. This session is for attendees who want to understand the full breadth of MasterControl Logbooks functionality and how this newly released product is enabling future development in Mx.

PRESENTED BY

Mucahit Agirtmis

Lead Product Manager

MasterControl

Elie Challita

Principal Product Manager

MasterControl

11:25 AM - 12:25 PM

The Transition to QMSR: How to Navigate FDA's New Quality Management Standards

Business Leadership

What does the transition from the FDA’s Quality System Regulation (QSR) to the Quality Management System Regulation (QMSR) mean for you? We’ll cover the key changes you need to know about in the transition as a medical device manufacturer. Learn how these changes will affect your quality management system and more. Then we’ll cover best practices for conducting a gap analysis and implementing the changes necessary to comply with the QMSR. This session is great for quality professionals in the medical device industry. 

PRESENTED BY

Nicolle Cannon

Founder/CEO

Cannon Quality Group, LLC

Claudette Lewis

Senior Quality Engineer

Cannon Quality Group

11:50 AM - 12:20 PM

The Cutting Edge of Quality Validation: VoD in Production

Demo Theater

SOLD OUT

MasterControl leads the industry in risk-based validation with our patented Validation Excellence (VxT) and Validation on Demand (VoD). Since initially launching with AQEM, customers have been able to validate their quality event processes whenever they need, at the click of a button and in minutes. Now, VoD can be done directly in your Production site, without affecting your data or sacrificing functionality. Join us to see VoD in Production in action, learn how it aligns with FDA guidance, and how it simplifies and streamlines software upgrades and validation requirements.

PRESENTED BY

Kevin Ballard

Senior Product Manager

MasterControl

12:25 PM - 1:55 PM

Lunch

If you have any dietary restrictions that are not accommodated by the buffet, kindly approach a Hyatt banquet service team member for assistance.

1:55 PM - 2:40 PM

How Process Improvement Strategies Can Enhance Innovation in Manufacturing

Business Leadership

Process improvement benefits manufacturing, quality, and, overall, delivers value to both internal and external stakeholders. Join us as we use real-world examples to show you how your organization can build processes rooted in alignment and collaboration that also foster innovation. You'll also get tips for an effective, rapid deployment of change initiatives. This session is great for quality and manufacturing professionals. 

PRESENTED BY

Ellen Grace Henson

CEO / Founder

Marketing Mechanics

1:55 PM - 2:25 PM

Streamline Manufacturing Operations With Mx & Logbooks

Demo Theater

SOLD OUT

We’ve added a new product to the Manufacturing Excellence (Mx) suite: MasterControl Logbooks. Logbooks is the first product extension of MasterControl Mx and it’s the prime digital solution to pesky paper-based logbooks. Join this session to see how Logbooks can be used to streamline manufacturing, from template management to auditing. This session is great for anyone who wants to learn more about how electronic logbooks can make tracking maintenance and regular tasks easier.

PRESENTED BY

Mucahit Agirtmis

Lead Product Manager

MasterControl

Elie Challita

Principal Product Manager

MasterControl

1:55 PM - 2:40 PM

The Revolutionary 8-Year Odyssey of Engineering and Quality Management at Veranex

Real-World Voices

Taking the right strategic approach to your quality management systems can truly be revolutionary for your business. Join us to hear what we’ve learned over the past 8 years engineering the quality management systems at Veranex. You’ll get insights into how we evaluated the needs, implemented and optimized the systems, and the concrete cost-cutting measures that helped eliminate the waste of overhead. You’ll also hear about our lessons learned that you can apply to the work you’re doing to enhance product quality, safety, and regulatory compliance. This session is great for all quality professionals looking to impact their organizations through better quality management. 

PRESENTED BY

Jay Ditoro

Director of Systems & Technology

Veranex

Edwin Chung

Vice President, Service Delivery

SPK and Associates

1:55 PM - 2:40 PM

Welcome to ADAPT

MC Innovation

The Advanced Data and Process Technology (ADAPT) Platform is MasterControl’s modern infrastructure for all advanced solutions and products. The ADAPT Platform enables modern data management and capabilities (like AI), is ultra-configurable, and provides more frequent releases to improve functionality and user experience with less business disruption. Join us for a discussion about what ADAPT means for you. See how you can use your test and production sites to accomplish sandbox, training, and production requirements, and how MasterControl is continuing to innovate in validation on ADAPT with Validation on Demand. This session is great for anyone who wants to see where MasterControl is headed.

PRESENTED BY

Ryan Castro

Vice President, Engineering

MasterControl, inc.

Erin Wright

Vice President, Product Management

MasterControl

2:35 PM - 3:05 PM

The Advantage of Native Connectivity and a Single Platform Approach

Demo Theater

Get an edge over the competition with a natively-connected platform that shares data and automates processes so your organization can run faster, leaner, and smarter. See the best way to connect and automate your quality and manufacturing for greater efficiency. Learn how MasterControl reduces errors, helps you discover actionable insights, and increases productivity with purpose-built AI. This session is great for quality and manufacturing pros who want to see MasterControl’s platform in action.

PRESENTED BY

Dallas Volk

Director, Solutions Consulting

MasterControl

2:50 PM - 3:35 PM

5 Tips to Improve User Adoption

Business Leadership

When it’s time to implement your quality management system (QMS) the hurdle of user adoption is real. How do you overcome the challenges that come from your users’ lack of experience, time constraints, and upgrade concerns? Join us as we explore 5 key things you can do to achieve high levels of user adoption – faster. This session is great for quality professionals who are looking for ways to boost user adoption of digital tools.  

PRESENTED BY

Melissa Leygan

Owner

eQMS Consulting LLC

2:50 PM - 3:35 PM

Automated Reviews with Ionis Configuration Specifications

Real-World Voices

Looking to dramatically reduce setup errors and the time you spend reviewing Master Templates? Learn how to use Ionis’ Configuration Specifications macro to customize your default step settings and automate your reviews of your settings. It’s a straightforward way to reduce review turnaround times and improve the overall quality of Master Templates. This session is great for manufacturing pros looking to work more efficiently. 

PRESENTED BY

Francis Ring

Director

Ionis Pharmaceuticals

2:50 PM - 3:35 PM

Customer Voices: Experiences From the Exam Generator Beta

Real-World Voices

Hear how the AI-driven Exam Generator feature works from MasterControl customers who have been using it as part of the product beta release. You’ll see demonstrations of the product in action and the benefits it brings to your company. You’ll get a first-hand look at the advantages of robust, multiple-choice generated exams versus read and understand training. You’ll also get tips for the best ways to use the tool at your company. This is a great session for quality and manufacturing professionals looking for more efficient and effective ways to improve training. 

PRESENTED BY

Anthony Contreras

Quality System & Validation, Director

Jamieson Wellness Inc.

Jim Ando

Manager, Innovation & Development

Pine Pharmaceuticals

Matt Seitz-Paquette

North America Quality Specialist

Fagron

Phyllis Fender

Senior Validation Manager

Carestream Health, Inc.

Renee VonBergen

Director, Product Management, AI/ML

MasterControl

3:15 PM - 3:45 PM

Improve Compliance With Electronic Logbooks

Demo Theater

SOLD OUT
Logbooks are a critical, yet time consuming, part of quality assurance. They’re used to track everything from cleaning to calibration and receiving to review. Paper logbooks are difficult to manage and are prone to getting lost, damaged, or just being plain unreadable. See how MasterControl Logbooks digitizes logbooks and greatly simplifies your development, execution, tracking, and review. Join us to see how Logbooks and Quality Excellence come together to improve compliance and help keep you on track. This session is great for anyone who wants to improve compliance in their company by leveraging an intuitive tool that makes tracking routine activities a breeze.

PRESENTED BY

Sue Echavarria

Senior Professional Service Consultant

MasterControl

3:35 PM - 4:05 PM

PM Break

4:05 PM - 4:35 PM

Advanced QEM—Your Processes, Your Way

Demo Theater

SOLD OUT
Advanced Quality Event Management (QEM) puts the power to build forms and workflows directly in your hands—no coding required. With Advanced QEM, quality leaders can start from scratch or use one of our powerful templates to create processes that work for your organization’s needs. Join us as we walk through building forms and workflows, extension requests, launching an event from Mx, Validation on Demand configuration mode, and more incredible functionality added in 2024. This session is great for any quality professional who wants to keep up with the latest advancements in the field.

PRESENTED BY

Dallas Volk

Director, Solutions Consulting

MasterControl

4:05 PM - 4:50 PM

Get the Most Out of Every MasterControl Update

MC University 201

Everybody loves new features and functionality in MasterControl. But it can be difficult to be sure you and your team are using the latest and greatest in the best ways possible. Join us to review the MasterControl upgrade process and discuss strategies for ensuring your teams can put new features to work ASAP. This session is great for all MasterControl admins.

PRESENTED BY

Keith Gibson

VP, Product Education

MasterControl

4:05 PM - 4:50 PM

Mastering the Road ahead with Manufacturing Excellence

MC Innovation

More than 200 companies trust MasterControl to help them manufacture life-changing products. Whether you’re part of that 200 or not, this is a chance to learn about Mx’s greatest hits from the past 12 months. Then see what’s coming in the next couple years, including an updated operator experience, additional opportunities for automation, and how greater connectivity and data analytics can help drive your company forward. This session is great for anyone who’s interested in learning more about Mx today and what the future holds for the product.

PRESENTED BY

Jake Ure

Senior Product Manager

MasterControl

Katie Farley

Sr Director or Product Management, Mx

MasterControl

4:05 PM - 4:50 PM

Uniting Sales and Quality for Customer Satisfaction and Organizational Success

Business Leadership

Ensuring quality is a cornerstone of exceptional customer experiences. Join us as we explore how quality professionals can team up with their sales teams to shape customer perceptions and ensure organizational success. We’ll use real-life examples and proactive strategies, to show you how to take ownership of your role in preventing issues, driving continuous improvement, and fostering a culture of quality excellence. This session is great for all quality professionals. 

PRESENTED BY

Christina Pecoraro

Owner & Founder

Lotus Business Solutions LLC

4:45 PM - 5:15 PM

Maximize the Power of Mx with System Integrations

Demo Theater

SOLD OUT

Learn how to get the most out of your manufacturing execution system by seamlessly integrating with critical software applications like ERP, LIMS, CRM, and more. Use the digital information in Mx to enable an unprecedented degree of insights across your entire enterprise. This session is great for customers who are interested in maximizing the value of MasterControl along with other key parts of your tech stack.  

PRESENTED BY

Andy Beier

VP Integrations

MasterControl

5:00 PM - 7:00 PM

The MXR – An Invitation Only Event

You’re among a select number of VIPs we’d like to see at our invitation only event for cocktails, conversation, and music! 

 

 Join us at Lake Effect, located at 155 W 200 S, Salt Lake City—just a two-minute walk from The Hyatt!

 

This event will offer a unique opportunity to: 

  • Network with peers and manufacturing experts. 
  • Gain insights into the benefits of adopting digital production records. 
  • Discuss best practices and innovative solutions to streamline your operations. 

 

Best of all, attend the event for a chance to win an Apple iPad Pro! 

Wed. / Oct. 16

Day 3

8:30 AM - 10:00 AM

Keynote Sessions

The Ultimate MasterControl Combo: Matt Lowe and Joseph Herath

Evolving your ADAPT Experience: Kiran Dhanuka and Ryan Keller

Transformative Manufacturing AI Starts by Transforming Your Data: Alex Jay and Adam Welsh

Tailoring a Regulatory Framework for the Responsible Use of AI: Danielle Dorfman Faruq

This is Where AI Gets Real: Sue Marchant and Renee VonBergen

PRESENTED BY

Alicia Garcia

Chief People and Culture Officer

MasterControl

Matt Lowe

Chief Strategy Officer

MasterControl

Joseph Herath

Vice President, Product Management

MasterControl

Kiran Dhanuka

Chief Customer Officer

MasterControl

Ryan Keller

Senior Director of Quality Assurance

doTERRA International LLC

Adam Welsh

Partner

West Monroe Partners

Alex Jay

Senior Manager

West Monroe Partners

Danielle Dorfman Faruq

Digital Health and AI Policy

Food and Drug Administration

Sue Marchant

Chief Product Officer

MasterControl

Renee VonBergen

Director, Product Management, AI/ML

MasterControl

10:00 AM - 10:30 AM

AM Break

10:30 AM - 11:15 AM

Mastering Your Master Templates

MC University 101

Looking to dramatically cut the costs and time you spend setting up production records? Do you ever have to rebuild the structure and details of a production record for each production run? See why Master Templates are the answer to these problems and more. We'll even walk you through how to build your own Master Template in Manufacturing Excellence so you can hit the ground running. This session is great for manufacturing professionals looking to streamline their production records and processes.

PRESENTED BY

Kirk Nunemaker

Senior Professional Services Consultant

MasterControl

10:30 AM - 11:15 AM

Real-World Tips: Managing Quality and Manufacturing Through Growth

Real-World Voices

There are a lot of advantages to having quality and manufacturing on the same platform. That’s especially true as your company grows via organic expansion or acquisition. Hear from Jamieson Wellness how MasterControl’s connected platform helped them navigate the challenges of growth. You’ll get insights and advice that you can put to work at your organization.  

 

 

PRESENTED BY

Anthony Contreras

Quality System & Validation, Director

Jamieson Wellness Inc.

10:30 AM - 11:00 AM

The Cutting Edge of Quality Validation: VoD in Production

Demo Theater

SOLD OUT

MasterControl leads the industry in risk-based validation with our patented Validation Excellence (VxT) and Validation on Demand (VoD). Since initially launching with AQEM, customers have been able to validate their quality event processes whenever they need, at the click of a button and in minutes. Now, VoD can be done directly in your Production site, without affecting your data or sacrificing functionality. Join us to see VoD in Production in action, learn how it aligns with FDA guidance, and how it simplifies and streamlines software upgrades and validation requirements.

PRESENTED BY

Kevin Ballard

Senior Product Manager

MasterControl

10:30 AM - 11:15 AM

The Three Keys to a Successful Solution Implementation

Business Leadership

IT projects fail more often than we like to admit. Sometimes they don't finish at all. Many times they complete, but strategic objectives aren't met. Join us to learn the key requirements in planning, managing, and leading complex software deployment projects in regulated spaces in a way that ensures not just project completion, but success. This session is great for IT, quality, and manufacturing professionals. 

PRESENTED BY

Joe Lucadamo

Vice President of Professional Services, Life Sciences

Focused Consulting, Inc.

11:10 AM - 11:40 AM

Maximize the Power of Mx with System Integrations

Demo Theater

Learn how to get the most out of your manufacturing execution system by seamlessly integrating with critical software applications like ERP, LIMS, CRM, and more. Use the digital information in Mx to enable an unprecedented degree of insights across your entire enterprise. This session is great for customers who are interested in maximizing the value of MasterControl along with other key parts of your tech stack.  

PRESENTED BY

Andy Beier

VP Integrations

MasterControl

11:25 AM - 12:25 PM

Keeping Up With Advanced Quality Event Management

MC Innovation

Advanced Quality Event Management (QEM) launched to much fanfare and success earlier this year as MasterControl customers took control of the quality events and realized the benefits of more flexible, data-driven processes. But we didn’t stop there. We've added an incredible number of functionality updates this year. Come see the new features including additional templates, Insights dashboards, interoperability with other MasterControl products, Validation on Demand configuration mode, GxPAssist AI Deviation Analyzer, and more. You’ll even get a sneak preview of what’s planned for 2025. This session is great for any quality professionals who want to learn about the latest and greatest solution in the field. 

PRESENTED BY

Eddie Vieira

Sr. Product Manager Advanced Products

MasterControl

Patricia Santos-Serrao

Senior Director of Product, Advanced Applications

MasterControl

11:25 AM - 12:25 PM

The Implications and Opportunities of Industry 4.O and AI for Manufacturing

Business Leadership

What do Industry 4.0 and AI mean for your manufacturing operations? How can you take advantage of these breakthrough technologies? What do you need to watch out for? Join us and learn how these advanced technologies can help you take your manufacturing to the next level. We’ll show you examples of real use cases that you can implement quickly to make an impact on your organization. This session is great for manufacturing professionals looking to stay ahead of the competition with help from the latest technologies. 

PRESENTED BY

Adam Welsh

Partner

West Monroe Partners

Alex Jay

Senior Manager

West Monroe Partners

11:25 AM - 12:25 PM

Welcome to MasterControl Academy

MC University 201

We have a brand-new learning environment for you and all your users. The new MasterControl Academy is going to make it much easier for you to learn what training is right for you. It even gives you the tools you need to assign training to your teams and analyze training data. You can also access any of our learning content (help files, knowledge base articles, and self-study courses) from the Academy home page, ensuring you get what you need when you need it. Come to this session to see how it all works!

PRESENTED BY

Katherine Crites

Sr. Manager of Learning Design

MasterControl

Keith Gibson

VP, Product Education

MasterControl

11:50 AM - 12:20 PM

Integrations for Advanced QEM

Demo Theater

SOLD OUT

MasterControl Advanced QEM gives you more control over your data than ever. Learn how it integrates your quality event processes with critical software applications like ERP, MES, LMS, CRM, and more. See how it can deliver automated data transfer and correlated insights across your entire enterprise to take your quality to the next level. This session is great for quality professionals looking to stay ahead of the competition when it comes to quality management. 

PRESENTED BY

Andy Beier

VP Integrations

MasterControl

12:25 PM - 1:55 PM

Lunch

If you have any dietary restrictions that are not accommodated by the buffet, kindly approach a Hyatt banquet service team member for assistance.

1:55 PM - 2:40 PM

8 ‘Wow Moments’ that Led to Now

Real-World Voices

‘Wow Moments’ can help propel you and your organization to greater heights. But how do you know when a ‘Wow Moment’ happens? What actions can help you encourage them to happen? And, most importantly, how do you turn a Wow Moment into real results now? Learn from the experience of MasterControl CEO Jon Beckstrand as he highlights 6 ‘Wow Moments’ from his career and how he used each one to get his company into a better position. This session is great for quality and manufacturing professionals looking take their organization and careers to the next level.  

PRESENTED BY

Jon Beckstrand

Chief Executive Officer

MasterControl

1:55 PM - 2:40 PM

A Proactive Approach to End-User Error

MC University 201

Everyone can make mistakes. Even your end users. Join us to learn how to save time and frustration by being proactive about these mistakes from the beginning. Attendees will learn how to manage the five most common end-user errors and learn how to prevent some of them from happening at all. This session is recommended for admins with a large number of end users.

PRESENTED BY

Ryan Jones

Manager, Learning Consulting

MasterControl

Jessica Jones

Manager, Content Curation

MasterControl

1:55 PM - 2:25 PM

The Future of the Mx Operator Experience

Demo Theater

SOLD OUT
In 2025 we will be rolling out one of the biggest updates to the Mx Operator Experience since we launched Manufacturing Excellence. Join us to see the updates to the interface and how it will simplify how your operators work. You’ll also learn how these updates will reduce planned downtime, streamline engagement, and further improve throughput. This is a great session for manufacturing pros who want to see how Mx is continually evolving to help you reach your goals.

PRESENTED BY

Jake Ure

Senior Product Manager

MasterControl

1:55 PM - 2:40 PM

The ‘5 P’s’ of Operationalizing a cGMP Manufacturing Facility

Business Leadership

Operationalizing a cGMP (Current Good Manufacturing Practice) manufacturing facility requires a well-planned and collaborative approach to ensure success. Join us as we cover the ‘5 P’s’ framework of GMP. You'll also learn how to choose the appropriate technology to help follow procedures processes and ensure compliance, efficiency, resulting in high–quality product production. This session is great for manufacturing and quality professionals in the pharmaceutical industry.

PRESENTED BY

Mohit Jumani

Enterey Consulting

2:35 PM - 3:05 PM

Putting Generative AI to Work In Your Pharma Process

Demo Theater

What could you do with a generative AI tool that caters for the privacy and accuracy concerns for pharma use? Join the team from Veqtor to learn more about their NEXA tool. You’ll learn how this new tool takes user requirement specifications (URS) and the technical specifications for equipment, ingests that information, then generates a best-in-class test case for the requirements. You’ll see an interactive demo of the tool so you can evaluate the efficiencies it can bring to your organization. We’ll also discuss how it can help achieve validation 4.0 principles of real-time verification of integrations with other systems in the digital ecosystem. This session is great for manufacturing and quality professionals in the pharma industry.  

PRESENTED BY

Phil Jarvis

director of CQV and digital validation strategy

veqtor solutions

2:50 PM - 3:35 PM

How to Wow Your Auditors

Real-World Voices

When you give auditors their own login and a clean and tidy set of information, it improves their experience and helps you get through an audit with a big thumbs up. Join us to learn how to leverage the power of creating a view-only user in MasterControl. You’ll also find out how to create worry-free explorer folders that limit auditors’ access to only the information they need to see. Whether you’re preparing an audit for the FDA, certifiers, or your customers—you’ll be able to set up an auditing environment that delivers proven high ratings. This session is great for all MasterControl users.  

PRESENTED BY

Robin Joyner

Quality Assurance Manager

Wellington Foods

2:50 PM - 3:35 PM

Maximize Mx with Logbooks

MC University 401

As the Manufacturing Excellence (Mx) suite grows, it's important to think through how the individual components can work together. Join us to learn about the newest tool in Mx—MasterControl Logbooks. We'll demonstrate its basic functionality and highlight how this new tool can pair with Production Records to build a solid foundation for your manufacturing processes. This session is for users considering digitizing their logbooks with MasterControl.

PRESENTED BY

Kirk Nunemaker

Senior Professional Services Consultant

MasterControl

2:50 PM - 3:35 PM

Overcome Your Software Validation Challenges

Business Leadership

Managing software validation and all the processes that go with it can be overwhelming for even the most experienced software validation professionals. Learn how a customized digital validation management system can make processes more efficient for your teams, lower costs for your company and save you lots of time. This session is great for quality and manufacturing professionals looking to improve their validation processes.

PRESENTED BY

Lisa Helmonds

VP, Quality & Regulatory

AVS Life Sciences

3:15 PM - 3:45 PM

Re-Think Your Processes with GxPAssist AI

Demo Theater

SOLD OUT

Artificial Intelligence (AI) is poised to significantly streamline processes for life-sciences professionals like you. See how GxPAssist AI tools from MasterControl are designed to deliver practical, powerful, compliant, and validated AI functionality to our customers in highly-regulated industries. Join us to learn more about our latest AI tools, like Exam Generator and Document Translator. Learn how they are designed to be low-risk, user-friendly applications that will help you automate manual tasks, improve efficiency, and save time. This session is great for any attendee who wants to learn more about how MasterControl is responsibly incorporating AI into our suite of solutions.

PRESENTED BY

Renee VonBergen

Director, Product Management, AI/ML

MasterControl

3:35 PM - 4:05 PM

PM Break

4:05 PM - 4:50 PM

How to Gather Meaningful ROI Data to Maximize Mx

Real-World Voices

Need solid ROI data to justify adoption or expansion of Manufacturing Excellence in your organization? We’ll show you how to gather clear, data-driven proof of performance and return on investment. Real MasterControl customers will show you how they built a strong business case by using system data and benchmark KPIs to unlock the full potential of digital manufacturing execution. This session is recommended for current Manufacturing Excellence users as well as Quality Excellence customers considering Manufacturing Excellence. 

PRESENTED BY

Brian Curran

SVP Mx Success

MasterControl

Michael Murphy

Associate Director - Automation & OT

Repligen

4:05 PM - 4:50 PM

Integrations Made Simple

MC University 401

You have a lot of different software solutions in your organization. And it can be a big challenge to share data between them all. Our new integrations strategy will make it much easier to send data from your batch records directly to other tools or sites. Join us to explore the basics of how to integrate MasterControl with other solutions—such as enterprise resource planning (ERP). This session is great for quality or manufacturing pros who need to share MasterControl data with other applications.

PRESENTED BY

Andy Beier

VP Integrations

MasterControl

4:05 PM - 4:35 PM

See Your Manufacturing Processes in a Whole New Way

Demo Theater

You can't measure what you can't see. Learn how to get a new level of visibility into your manufacturing data with dashboards that let you stay updated on status and trends, spot bottlenecks, avoid delays, and work smarter. We'll briefly review out of the box reports tailored toward production and take you through the process of building useful custom dashboards and reports in Premium Insights. This is a great session for anyone who wants to get more value out of Premium Insights and see its features in action.

PRESENTED BY

Kirk Nunemaker

Senior Professional Services Consultant

MasterControl

4:05 PM - 4:50 PM

The Latest in Quality Excellence

MC Innovation

Join us to see the what’s new, including how our pursuit of FedRAMP authorization improves security for all users, upcoming integrations with ADAPT products, and a preview of features and functionality planned for the future. This session is for anyone who uses or is interested in Quality Excellence. 

PRESENTED BY

Dave Hunter

Product Management Director

MasterControl

4:45 PM - 5:15 PM

Remove Data Entry Errors by Embracing Automation

Demo Theater

SOLD OUT
Data entry errors can be the downfall of high-quality manufacturing, resulting in wasted resources, a scrapped batch or even something as serious as a 483-warning letter. By automating essential production tasks, MasterControl Manufacturing Excellence can remove up to 90% of error-prone steps. Join us to learn all the ways you can use embedded automation – from simple calculations to complex conditional pathing – to accelerate cycle times, reduce the opportunity for human error, and decrease the number of resources needed for production. This session is great for manufacturing or quality pros who want to learn more about how Mx contributes to cost and time savings.
5:00 PM - 6:00 PM

AI Happy Hour

Join us for drinks and your chance to influence the future of AI tools in MasterControl. AI tools will help you the most when they’re built on real ideas from real people.  And who has better ideas about what will help you, than you? Bounce your AI ideas off your colleagues, brainstorm new ones, and submit as many potential AI-powered features you can via our digital forms so we can build a better MasterControl for you.  

Thurs. / Oct. 17

Day 4

8:30 AM - 10:00 AM

Keynote Sessions

Digital Evolution: A Success Story Backed by Data: Katie Farley and Michael Murphy

A Proven Experience: Quality + Manufacturing Are Better Together: Jennifer Rodriguez

Frontline Focus: PCI Pharma Services Path to Transformation: Dave Edwards and Lori Jackson

Now, Next, Later: The Power of Mx: Mucahit Argimitis and Elie Challita

Your AI Wish List Revealed: Sue Marchant

Hackathon Reveal: Erin Wright and Ryan Castro

Masters of Excellence Awards: Jon Beckstrand and Alicia Garcia

PRESENTED BY

Katie Farley

Sr Director or Product Management, Mx

MasterControl

Michael Murphy

Associate Director - Automation & OT

Repligen

Jennifer Rodriguez

Corporate Quality Systems Manager

QuVa Pharma

Dave Edwards

Chief Revenue Officer

MasterControl

Lori Jackson

Senior Director, Global Digital Quality & Program Management

PCI Pharma Services

Mucahit Agirtmis

Lead Product Manager

MasterControl

Elie Challita

Principal Product Manager

MasterControl

Sue Marchant

Chief Product Officer

MasterControl

Erin Wright

Vice President, Product Management

MasterControl

Ryan Castro

Vice President, Engineering

MasterControl, inc.

Jon Beckstrand

Chief Executive Officer

MasterControl

Alicia Garcia

Chief People and Culture Officer

MasterControl

10:00 AM - 10:30 AM

AM Break

10:30 AM - 11:15 AM

Build a Training Plan in MasterControl Academy

MC University 201

Consistently training your team on how to use MasterControl increases adoption, improves efficiency, and boosts your ROI. Join us to learn how to build a training plan in the new MasterControl Academy. Your plan will help keep your whole team updated on the latest features and functionality of the software. We'll also show you how to track training data to ensure your team stays fully trained and compliant. This session is great for MasterControl system administrators.

PRESENTED BY

Katherine Crites

Sr. Manager of Learning Design

MasterControl

Keith Gibson

VP, Product Education

MasterControl

10:30 AM - 11:15 AM

CSA and MasterControl - Reducing Validation Effort and Remaining Compliant

Real-World Voices

Learn how to reduce the burden of documentation and maintain compliance long-term using a Computer Software Assurance (CSA) approach to validation. We’ll take you through a case study that begins with an implementation of MasterControl which was replacing 49 custom databases running on obsolete technology. See how the testing process was reduced from 12 weeks down to 2 days. Then find out how to use Validation On Demand to reduce validation and verification work long term by automating the most customized components of the system. This session is great for anyone looking to implement a CSA approach to validation.

PRESENTED BY

Phyllis Fender

Senior Validation Manager

Carestream Health, Inc.

10:30 AM - 11:15 AM

Enhance Your Operations with a Risk-Based Approach to Quality and Compliance

Business Leadership

Managing quality and compliance is vital to ensuring patient safety and meeting stringent regulatory standards. A risk-based approach to quality and compliance can help you meet those high standards and deliver actionable insights and strategies to enhance your operations. Join us to learn techniques for identifying, assessing, and prioritizing risks within life sciences operations. Then hear about real-world case studies that illustrate the practical application and successful implementations of risk-based quality management. This session is great for all quality professionals.  

PRESENTED BY

Sean Winslow

CEO

2030 Consulting

10:30 AM - 11:00 AM

The Advantage of Native Connectivity and a Single Platform Approach

Demo Theater

Get an edge over the competition with a natively-connected platform that shares data and automates processes so your organization can run faster, leaner, and smarter. See the best way to connect and automate your quality and manufacturing for greater efficiency. Learn how MasterControl reduces errors, helps you discover actionable insights, and increases productivity with purpose-built AI. This session is great for quality and manufacturing pros who want to see MasterControl’s platform in action.

PRESENTED BY

Dallas Volk

Director, Solutions Consulting

MasterControl

11:10 AM - 11:40 AM

Advanced QEM—Your Processes, Your Way

Demo Theater

SOLD OUT
Advanced Quality Event Management (QEM) puts the power to build forms and workflows directly in your hands—no coding required. With Advanced QEM, quality leaders can start from scratch or use one of our powerful templates to create processes that work for your organization’s needs. Join us as we walk through building forms and workflows, extension requests, launching an event from Mx, Validation on Demand configuration mode, and more incredible functionality added in 2024. This session is great for any quality professional who wants to keep up with the latest advancements in the field.

PRESENTED BY

Dallas Volk

Director, Solutions Consulting

MasterControl

11:25 AM - 12:10 PM

4 Keys to Accelerating Your MasterControl Onboarding

Real-World Voices

How do you go from paper to fully digital MasterControl processes as fast as possible? Join us to find out the four key decisions Kindeva made to get a new location up and running! You’ll hear how the team found and filled gaps. You’ll also learn the important initiatives the team put into practice that could benefit other customers as they’re preparing to implement MasterControl. This session is great for quality pros looking to onboard new and acquired sites.   

PRESENTED BY

Joan Fretag

Director of Integration and Business Transformation

Kindeva Drug Delivery

Catherine Fitchett

Global Quality Systems Manager

Kindeva Drug Delivery

11:25 AM - 12:10 PM

Behold the Power of AQEM + Insights

MC University 301

Advanced QEM is a powerful tool, but you can make it even stronger with Insights. Join us to see the top ways Insights can help you track your QEM data. Learn how to build dashboards and visualizations that will give everyone on your team access to the data that will help you understand and anticipate quality events better than ever before. This session is great for any quality professional looking to maximize your efficiency and effectiveness.

PRESENTED BY

Jared Evans

Learning Implementation Manager

MasterControl

Maggie Morscher

Manager of Internal Learning Strategy

MasterControl

12:10 PM - 1:40 PM

Lunch

If you have any dietary restrictions that are not accommodated by the buffet, kindly approach a Hyatt banquet service team member for assistance.

1:00 PM - 5:00 PM

Creating Advanced Forms With AQEM

Workshop

OptionalSOLD OUT
Advanced Quality Event Management (AQEM) is 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 new users of the Advanced Quality Event Management tool.

PRESENTED BY

Jacob Russo

Learning Experience Designer

MasterControl

1:00 PM - 5:00 PM

Docs and Training Collaboration

Workshop

OptionalSOLD OUT
Using Documents and Training together can increase your efficiency, but only if you know how they work together. Join us for a hands-on education of best practices for using the Documents and Training modules together, then join us for a friendly competition (for bragging rights!) as you and your fellow attendees navigate real situations that require the two modules in collaboration. This session is for those looking to improve their efficiency in the Documents and Training modules.

PRESENTED BY

Stephanie Marshburn

Learning Consultant

MasterControl

1:00 PM - 5:00 PM

Enhancing Manufacturing Efficiency With Logbooks

Workshop

Optional
Logbooks are a vital component of successful manufacturing, but only if properly integrated with electronic batch records. Are your current batch records up to the task? See why competitive manufacturers are ditching paper and making the switch to digital. Join us to see how using MasterControl Logbooks with MasterControl Manufacturing Excellence can easily and efficiently integrate your electronic batch records and offer better, more accurate records across the board. This session is for anyone interested in learning more about MasterControl Logbooks.

PRESENTED BY

Elie Challita

Principal Product Manager

MasterControl

Mucahit Agirtmis

Lead Product Manager

MasterControl

1:00 PM - 5:00 PM

Increasing Adoption With End-User Training

Workshop

Optional
End-user training increases adoption and improves efficiency and your ROI. In this workshop, you'll cover the theory and practice of training end users. You'll receive help in building a training plan for your team, including communications strategies, tracking approaches, and refresh plans. Additionally, you'll explore the details of importing end user training into MasterControl and dive deep into the end-user roles for which we provide training in Quality Excellence, Manufacturing Excellence, Enhanced Forms, and Audit. This session is for anyone looking to increase adoption at their organization.

PRESENTED BY

Kris Peek

Sr. Learning Experience Designer

MasterControl

1:00 PM - 5:00 PM

Mastering Data With Manufacturing Excellence and MasterControl Insights

Workshop

Optional
Users of MasterControl Manufacturing Excellence can use the MasterControl Insights tool to get more out of their system! Join us to for an overview of the reporting and visualization capabilities offered by MasterControl Insights in a Manufacturing Excellence environment. Attendees will learn more about reporting and visualization capabilities and the steps of creating and editing their own reports. This session is for Manufacturing Excellence users with Premium Insights.

PRESENTED BY

Ryan Jones

Manager, Learning Consulting

MasterControl

Fri. / Oct. 18

Day 5

7:00 AM - 8:00 AM

Workshop Breakfast

8:00 AM - 12:00 PM

Creating Advanced Forms With AQEM

Workshop

Optional
Advanced Quality Event Management (AQEM) is 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 new users of the Advanced Quality Event Management tool.

PRESENTED BY

Randy Jensen

MasterControl

8:00 AM - 12:00 PM

Simplifying Validation With Validation on Demand

Workshop

Optional
Validation is long and time-consuming, but it's absolutely essential to your quality and manufacturing operations. Enter MasterControl's new Validation on Demand process! Join us to see how this new tool automates the most challenging aspects of validation for users of both MasterControl Quality Excellence and MasterControl Manufacturing Excellence. Attendees will learn how to use Validation on Demand with their existing modules. This workshop is intended for admins new to using Validation on Demand.

PRESENTED BY

Jacob Russo

Learning Experience Designer

MasterControl

8:00 AM - 5:00 PM

Surprise, You’re a SysAdmin

Workshop

Optional
What is a new MasterControl sysadmin to do when they suddenly find themselves responsible for managing and maintaining the application and training its users? Join us as we explore how the pieces of your MasterControl system are interconnected and how to use them in your new position. This session is best for new sysadmins who already have a working knowledge of life cycles, InfoCard metadata, roles, and collaboration.

PRESENTED BY

Jared Evans

Learning Implementation Manager

MasterControl

12:00 PM - 1:00 PM

Workshop Lunch

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