The Conference Program

Fusion 2018 planning is well underway. You can anticipate a program packed with plenty of knowledge sharing, hands-on learning, and countless opportunities to network with fellow SmartSolve users, Pilgrim subject matter experts, and industry authorities. Whether you simply attend the 3-day conference, or extend your stay in the Tampa Bay area before and/or after Fusion to take advantage of additional SmartSolve Training and/or recreational activities, we promise your Fusion 2018 experience will be memorable and worthwhile.

Agenda

The schedule below provides a comprehensive look at what the Fusion 2018 experience will include before, during, and after the 3-day conference.

Select Day

7:00am - 7:00pm

Registration Opens

8:00am - 1:00pm

Pilgrim Golf Outing (Optional)

2:00pm - 5:00pm

Customer Advisory Board Meeting (Invitation-Only)

6:00pm - 9:00pm

Fusion 2018 Welcome Reception

Breakfast7:00am - 8:00am

8:00am – 10:00am

General SessionFusion 2018 Welcome

Pilgrim will welcome Fusion 2018 attendees to the conference and highlight the improvements made to the event to better suit your needs. We will also share what has been heard from customers and our plans for addressing customer needs into the future.

Break 10:00am - 10:30am

10:00am - 5:00pm

The Zone

Visit the new and expanded “Zone,” where Pilgrims, partners, analysts, and other thought leaders converge. Meet with some of the industry’s best of the best, along with Pilgrim industry and solution experts from Customer Support, Professional Services, Training, Development, Product Management & Regulatory Training, and Sales and Marketing.

10:30am - 5:00pm

Executive Track

Exclusive Executive Track geared toward executive management to hear and discuss thought-leading topics facing the industry today and in the future.

10:30am – 11:30am

Products & SolutionsThe Newest Features and Functionality in SmartSolve

What SmartSolve version are you currently running? When did you last upgrade? Attend this session to get a rundown of all the new SmartSolve features and functionality made available over the last several releases and find out why you should care.

Products & SolutionsSmartSolve Complaint Management and Case Intake Portal - A Customer Success Story

Join our Pilgrim Global Services team to review the key elements of a successful customer implementation and related use cases surrounding Pilgrim's SmartSolve Complaint Management solution.

Regulatory & ComplianceWhat's New with FDA Regulations?

Join Pilgrim's regulatory experts for an update on recent and upcoming FDA regulations that will impact you and your organization's people, products and processes.

Technical & AdministrationIntegrating SmartSolve with Other Enterprise Systems

Join this session to get an overview of SmartSolve integration solutions and capabilities, different integration approaches, and how to choose the right tools. In addition, we will review real-world examples and provide a live demo of SmartSolve integration capabilities.

Lunch 11:30am - 1:00pm

1:00pm – 2:00pm

Products & SolutionsBusiness Process Automation with SmartSolve Studio

This session will examine how requirements-driven development using Pilgrim's low-code platform can enhance your business processes.

Products & SolutionsSmartSolve CAPA Management - A Customer Success Story

Pilgrim's Global Services team will walk you through a successful customer implementation and provide related use cases surrounding SmartSolve CAPA Management.

Regulatory & ComplianceUpcoming European Regulatory Changes - EU MDR

Join Pilgrim's regulatory experts for an update on recent and upcoming European regulations that will impact you and your organization, such as EU MDR.

Technical & AdministrationConfiguring and Leveraging SmartSolve Dashboards (Things To Do Lists)

Join our Pilgrim Global Services team for an overview and discussion of best practices related to configuring and leveraging dashboards and saved searches in SmartSolve.

2:15pm – 3:15pm

Products & SolutionsQuality Intelligence, Executive Dashboards, and Data Discovery

Analyzing real time data across multiple quality processes has become critical in making intelligent business decisions. Join us in this session to learn how you can both leverage the new pre-built KPI dashboards and create personalized executive-level dashboards to monitor the quality health of your company.

Products & SolutionsSmartSolve Quality Intelligence - A Customer Success Story

Join our Pilgrim Global Services team to review a successful customer implementation and related use cases surrounding Pilgrim's Quality Intelligence solution.

Thought LeadershipWhy Is the World So Cloudy?

Come hear about the latest trends in Cloud computing and why those trends are important to you. You'll also get a glimpse into Pilgrim’s Next Generation Cloud concepts.

Technical & AdministrationSmartSolve Platform, Technology, and Administration - The Latest Updates

Take an inside look at the latest platform releases to uncover recent enhancements and new capabilities. In addition, in this session we will discuss the benefits of the quarterly release cycle and how to best plan for your upgrades.

Break - The Zone3:15pm - 4:00pm

4:00pm – 5:00pm

Products & SolutionsEnd-to-End Complaint Management and FDA Gateway Submissions

Complaint handling requirements for Life Sciences organizations are constantly evolving. Join this session to view a demonstration of Pilgrim's end-to-end Complaint Management process, and learn how SmartSolve can automate electronic submissions to the FDA.

Products & SolutionsSmartSolve Document and Training Management - A Customer Success Story

The Pilgrim Global Services team will present an inside look at a successful customer implementation and related use cases surrounding SmartSolve Document Management and Training Management.

Thought LeadershipPredictive Analytics is the Path to True Prevention

How do you find patterns in data around quality issues including product failures, recalls, injuries/deaths, where no one has thought to look? Join this session to learn how to uncover hidden insights that will leave your competition in the rearview mirror.

Technical & AdministrationFederated Single Sign On: Capabilities and Best Practices

What is FedSSO and how does SmartSolve address it? Find out what Pilgrim's experts have learned and the best practices adopted by executing various integrations with different Identity Providers in the quality space.

White Out Dinner Party6:00pm - 10:00pm

Breakfast7:00am - 8:00am

7:00am - 5:00pm

The Zone

Visit the new and expanded “Zone,” where Pilgrims, partners, analysts, and other thought leaders converge. Meet with some of the industry’s best of the best, along with Pilgrim industry and solution experts from Customer Support, Professional Services, Training, Development, Product Management & Regulatory Training, and Sales and Marketing.

8:00am - 9:00am

General Session

9:15am – 10:15am

Products & SolutionsAutomated Validation is Today's Reality

Explore Pilgrim's Automated Validation capability and discover how it differs from traditional automation, including a look at the concept of testing requirements versus design and how Pilgrim uses this automation in our Cloud. A live demonstration will illustrate how to quickly generate and execute PQ for the change with complete traceability and with rich evidence.

Products & SolutionsManaging OOS/OOT with SmartSolve

Learn how to track and manage all of your Out of Specification (OOS) and Out of Trend (OOT) quality records within your laboratories and discover how SmartSolve’s OOS/OOT workflow resolves problems quickly, minimizes risks, and provides excellent management oversight. We will also present a live demonstration of SmartSolve's closed-loop OOS workflow in action.

Regulatory & ComplianceISO 9001:2008 Compliance at Pilgrim Quality Solutions

Attend this session for a review of Pilgrim's Software Development Life Cycle (SDLC) that guides the development of new products and the enhancement and maintenance of existing products. Discover how our SDLC ensures that we consistently deliver software to our customers that conforms to established and contracted technical requirements.

Thought LeadershipData Security and The Cloud

Attend this presentation for a 5,000-foot view of security in the cloud. We will examine where we have been, where we are today, and where we are going with data protection practices and technologies.

Break - The Zone10:15am - 10:45am

10:45am – 11:45am

Products & SolutionsRisk Management and Your SmartSolve System

ISO 13485:2016 requires that manufacturers take a more risk-based approach to quality processes, and SmartSolve supports the new requirements with its tools and capabilities that allow you to leverage risk-based thinking while managing your quality events. Join this session to get an overview of how SmartSolve can help your organization reduce its overall quality risk.

Products & SolutionsEnd-to-end Supplier Quality Management

This session will review the Supplier Quality Management tools available in SmartSolve and the additional supplier evaluation and selection tools available for supporting on-going supplier management processes. Hear about supplier performance data such as audit records, incoming inspection data, nonconformance records, and CAPA responses, and Pilgrim's new Supplier Quality Portal.

Regulatory & ComplianceA Look Inside the Pilgrim Validation Pack

This overview will walk you through the documents included in a SmartSolve Validation Pack, as well as some additional ones that can assist you in your Pilgrim Quality Solutions validation project. We will look at the Getting Started Guide, Release Notes, Validation Matrix, and more.

Thought LeadershipRapid Implementation of New SmartSolve Quality Processes

Join our Pilgrim Global Services team to discuss best practices and Pilgrim's methodology for rapid implementation of the newest SmartSolve quality processes.

Lunch 11:45am - 1:00pm

1:00pm – 2:00pm

Products & SolutionsManaging Organizational Changes That Impact Your Documents

Good Change Management processes are critical to sustaining quality within your organization. Rarely does a change occur that does not impact some set of documentation. Join this session for an overview of SmartSolve Change Management and how it tightly integrates with SmartSolve Document Management.

Products & SolutionsPilgrim Cloud Overview

Learn what Pilgrim has in store to host your SmartSolve QMS in the cloud. Our Cloud experts will discuss how to remove common barriers so that your organization will require less IT infrastructure and your overall costs will be reduced.

Thought LeadershipIndustry 4.0: Why Quality Cares and How to Prepare

The impact of Industry 4.0 on our manufacturing, supply chains and quality management will be felt sooner than we think, and as quality professionals, we need to be planning for it now. Join this session to gain an understanding of Industry 4.0, its expected impact on our organizations' products and processes, and the role technology will play in reshaping the way we work.

Technical & AdministrationSmartSolve Roles, Rights, and User Maintenance

Join our Pilgrim Global Services team for an overview and discussion of best practices and tips and tricks for setting up and maintaining Roles, Rights, and Users in SmartSolve.

2:15pm – 3:15pm

Products & SolutionsNext Gen Document Management and Collaboration

Document Management is at the heart of your Quality Management System and Pilgrim continues to evolve this vital process with new technology and capabilities. Join this session to get a look at the latest version of SmartSolve Document Management and an overview of new functionality, including enhanced collaboration tools.

Products & SolutionsSmartSolve Change Management - A Customer Success Story

The Pilgrim Global Services team will share the ins and outs of a successful customer implementation and present related use cases surrounding SmartSolve Change Management.

Thought LeadershipThe Rise of Automation and Its Impact on Quality

Technology is driving the next industrial revolution and the way man, machine, and information interact is going to change. Join this session to review approaching technologies, their role in the Life Sciences industry, the impact they will have on the way we execute our processes, and their impact on Quality.

Technical & AdministrationAccelerating SmartSolve System Performance

In this session, we will introduce Pilgrim’s methodology for improving SmartSolve's system performance and fine tuning application deployment.

Break - The Zone3:15pm - 4:00pm

4:00pm – 5:00pm

Products & SolutionsThe Newest Features and Functionality in SmartSolve

What SmartSolve version are you currently running? When did you last upgrade? Attend this session to get a rundown of all the new SmartSolve features and functionality made available over the last several releases and find out why you should care.

Products & SolutionsLeverage Equipment and Calibration Management to Increase Efficiency

Out-of-service equipment costs significantly more than the cost to maintain it. Join this session to learn how to reduce waste and scrap by leveraging SmartSolve to manage your equipment and tools' accuracy and efficiency.

Thought LeadershipCombination Products: Today and Tomorrow's Quality and Regulatory Environment

Don't miss this session for a look at the current quality and compliance climate for combination products. We'll review combination products types and processes and the regulatory authority interactions that impact product development and distribution, as well as examine some of the challenges that accompany combination products and what the future holds for this innovative Life Sciences sector.

Technical & AdministrationGlobal SmartSolve and Support for Multiple Languages (Internationalization)

How can you maintain your competitive edge with a distributed team in the global environment? Take some time to learn about Pilgrim’s Internationalization capabilities and how those extend to your critical quality system and data.

Fusion 2018 Beach Party & Dinner5:30pm - 10:00pm

Breakfast7:00am - 8:00am

7:00am - 11:00am

The Zone

Visit the new and expanded “Zone,” where Pilgrims, partners, analysts, and other thought leaders converge. Meet with some of the industry’s best of the best, along with Pilgrim industry and solution experts from Customer Support, Professional Services, Training, Development, Product Management & Regulatory Training, and Sales and Marketing.

8:00am – 9:00am

Products & SolutionsNext Generation RIMS for Next Generation Quality

Join this session to learn how your company can start leveraging next-generation RIMs to improve the exchange of regulatory information, optimize RA project planning, support global submissions strategy, track products registrations, develop regulatory intelligence, reduce risks related to changes, simplify reporting, and provide insight into regulatory operations.

Products & SolutionsAutomated Validation is Today's Reality

Explore Pilgrim's Automated Validation capability and discover how it differs from traditional automation, including a look at the concept of testing requirements versus design and how Pilgrim uses this automation in our Cloud. A live demonstration will illustrate how to quickly generate and execute PQ for the change with complete traceability and with rich evidence.

Regulatory & ComplianceWhat's New with FDA Regulations?

Join Pilgrim's regulatory experts for an update on recent and upcoming FDA regulations that will impact you and your organization's people, products and processes.

Thought LeadershipIndustry 4.0: Why Quality Cares and How to Prepare

The impact of Industry 4.0 on our manufacturing, supply chains and quality management will be felt sooner than we think, and as quality professionals, we need to be planning for it now. Join this session to gain an understanding of Industry 4.0, its expected impact on our organizations' products and processes, and the role technology will play in reshaping the way we work.

9:15am – 10:15am

Products & SolutionsQuality Intelligence, Executive Dashboards, and Data Discovery

Analyzing real time data across multiple quality processes has become critical in making intelligent business decisions. Join us in this session to learn how you can both leverage the new pre-built KPI dashboards and create personalized executive-level dashboards to monitor the quality health of your company.

Products & SolutionsBusiness Process Automation with SmartSolve Studio

This session will examine how requirements-driven development using Pilgrim's low-code platform can enhance your business processes.

Regulatory & ComplianceUpcoming European Regulatory Changes - EU MDR

Join Pilgrim's regulatory experts for an update on recent and upcoming European regulations that will impact you and your organization, such as EU MDR.

Thought LeadershipExtending QMS Beyond the Four Walls of QA

The list of organizational quality stakeholders continues to grow as the value chain expands. Join this session to review key SmartSolve capabilities that enable a quality culture within your organization, moving quality from a departmental responsibility to an organizational responsibility.

Break - The Zone10:15am - 10:45am

10:45am – 11:45am

Products & SolutionsLet's Talk about Recall Management

Managing product removals and corrections is a complex process that touches many aspects of your extended value chain. In this session, we will discuss how Pilgrim views Recall Management and how we can help automate and control the end-to-end process.

Products & SolutionsThe Case for Inspection Management

Managing suppliers is key to minimizing risk and improving quality within the supply chain. This session will provide an overview of Inspection Management, the role it plays in Supplier Quality Management, and the new and evolving regulations it supports.

Regulatory & ComplianceBest Practices for FDA Audit Readiness

During this session, Pilgrim will facilitate a discussion on audit best practices, what you may encounter during your next visit from the FDA, and how you can stay one step ahead, including leveraging SmartSolve to mine important information.

Thought LeadershipData Quality Equals Quality Data

Data is part and parcel to life today. This session will demonstrate how you can prevent bad data or overlooked information from misguiding your journey to quality excellence.

Lunch 11:45am - 1:00pm