Pilgrim Software's Fusion 8: Shifting Quality into High Gear, November 7-10 at the Innisbrook Resort, Palm Harbor, Florida

SUNDAY, November 7, 2010

6:00 AM - 6:30 PM

Getting the Most out of your Fusion 8 Experience!
Fusion first timers and returnees alike can learn how to optimize their Fusion experience. With three simultaneous events occurring throughout the day, selecting a session is a challenge – especially for Fusion ‘first timers.” Hear from key Pilgrim personnel on strategies to absorb as much as possible before Fusion 8 closes.

MONDAY, November 8, 2010

10:15 AM - 12:00 PM

PILGRIM ROADMAP
Pilgrim Product Roadmap and Strategy 2011
Pilgrim’s Chief Technology Officer Atulya Risal will share the Plan of Record for Q&MIS® and SmartSolve® for 2011, including an overview of all releases, enhanced functionality as well as release dates. Understand how you can participate in Pilgrim’s product future direction. The presentation also will unveil future products for Pilgrim’s SmartSolve Integrated Compliance Platform including sneak peeks for 2011 and vision and direction for Q&MIS and SmartSolve into next year and beyond.

1:20 PM - 2:15 PM

Best Practices Improvements in SmartSolve® 9
SmartSolve® 9 drives usability and functional enhancements across all SmartSolve solutions. Get your ticket to see demonstrations of the new capabilities added to SmartAudit™, SmartDoc™, SmartComplaints™ and SmartTrain™ and the features you have been asking for your System Administrators. This is a “Must See” to show how SmartSolve 9 continues to enhance the end-user’s experience navigating and working through your quality business processes.

2:20 PM - 3:15 PM

SmartDesigner™ - An Inside Look at Pilgrim’s Newest Business Applications
Learn how, by using SmartDesigner™, you can empower yourself to create and address an unlimited number of automated tracking processes. In this session, see how using SmartDesigner, a new form can quickly be created on the fly to meet additional quality and compliance operational processes, and hear about other handy capabilities from Pilgrim that will drive your efficiencies and ensure your quality and compliance.
Note: A special SmartDesigner™ bootcamp will be held November 11-12 at Pilgrim’s Tampa Learning Center. Contact Nancy DeFilippis for details.

3:30 PM - 4:30 PM

Hall 1
Digital Transformation for Paper-Based Documents (Adlib / Pilgrim)
In today’s economic times, companies need to look at improving productivity and reducing costs associated with handling, searching, and storage of paper documents. Efficiently capturing, classifying, distributing and storing paper forms and documents can be a labor-intensive process often prone to error and open to data security risks. In addition, there is a high risk of paper forms and documents being lost or destroyed. In this session, learn how integration between Pilgrim’s SmartSolve® and Adlib Express allows you to automate the intake of paper forms and documents from scanners and fax machines and load it directly into Pilgrim’s solution with the correct data captured into a Smart Solve record. Discover how, with this automation, as business grows, their costs don’t.

Hall 2
Quick!!! How do I find an MSDS?
Where are the binders? Most companies have their Material Safety Data Sheets (MSDS) stored in binders in “strategic” locations within their company or have contracted with an outside storage source. Listen to how Anderson Packaging, with its present initiative, Hazardous Communication – It’s the Employee’s Right To Know, is stepping up to use SmartDoc™ as a vehicle to make MSDS more accessible to the employee and to exceed OSHA’s Hazardous Communication directive.

Hall 3
Getting Prepared to Move to SmartSolve® Version 9
Miss the webinar? Thinking of upgrading but don’t know what SmartSolve® 9 functionality is all about? Attend this workshop to take a tour of the new features and benefits in this latest SmartSolve release. In addition, learn about the upgrade path and platform certification. Live demo included. This is a must session for those considering an upgrade to SmartSolve 9!
***Encore presentation on Wednesday at 10:30am in Hall 1

4:45 PM - 6:00 PM

Hall 1
FDA Regulated SIG Group

Hall 2
Manufacturing SIG Group

Hall 3
Blood SIG Group

TUESDAY, November 9, 2010

7:30 AM - 9:00 AM

Continental Breakfast / Laboratory Users Roundtable Discussion
Clinical and medical laboratories need to sustain a commitment to quality and demonstrate a certifiable level of compliance. Join your laboratory industry colleagues in this informal roundtable discussion to share how your organization uses Pilgrim’s solutions to enable you to sustain compliance and ensure ongoing viability and performance. During this forum, you will:

Meet and share contact info between laboratory-based users of SmartSolve®
Discuss current modules implemented and used within laboratories
Discuss key learning points during SmartSolve® module implementations and usage after go-live
Discuss the benefits that have been realized since implementation
Discuss how to quantify improvements through using SmartSolve® modules (cost, time, quality impact)
Discuss approaches to testing and validation
Discuss hurdles/barriers that different companies face and how they are tackling them

8:00 AM - 8:55 AM

Creating New Business Apps (Pt. 1)
During these turbulent economic times, companies are being forced to tighten their belts and drive existing resources to do more with their operating infrastructure. With SmartDesigner™, now’s the time for you to reflect on what more can you automate within your organization to get more value out of your SmartSolve solution while increasing your process efficiency. In this first session, you will understand what different configuration tools are available to allow business analysts to configure and route new forms and associate them with workflow processes. Learn about building new applications through sample demonstrations such as invoicing tracking, initiating supplier evaluations, capturing and reporting OSHA incidents and more.
Note: A special SmartDesigner™ bootcamp will be held November 11-12 at Pilgrim’s Tampa Learning Center. Contact Nancy DeFilippis for details.

9:00 AM - 10:00 AM

Hall 1
Good Governance for Supply Chain Vendor Compliance
As a result of the growing complexity and awareness of the global supply chain management process, companies need to sit up and pay attention to their supplier quality programs. Through this engaging session you will hear how global organizations can efficiently and effectively manage their value-chain processes as global regulatory oversight continues to expand.

Hall 2
The Changing Face of Quality in a Manufacturing Environment
This presentation explores the changing role of Quality in a manufacturing environment, addressing issues of inspection methods and techniques, supplier control, and internal process views. Discover how these roles have changed as businesses expand more globally, with a look at where the Quality function is going in the future.

Hall 3
Reduce Document Preparation Time with Collaborative Document Review
Producing a quality document is a collaborative process which takes time and commitment. By making the process efficient and transparent, companies can reduce document preparation time by 65% and thus provide significant savings.

10:25 AM - 11:30 AM

Hall 1
Moving Beyond Compliance: Reinvention of Enterprise Risk Management
To deliver sustainable risk and compliance practices, companies need to integrate regulatory compliance and quality management into their Enterprise Risk Management vision. Quality and regulatory management, as part of operational risk, is the foundation for a successful Enterprise Risk Management strategy. Companies are best advised to take a full lifecycle approach to understand managing product and quality compliance as an overall health check for the company and its stakeholders’ future success.

Hall 2
How Cubic Defense Used SmartSolve® V9 Platform and SmartDesigner™ to Automate Production Traveler System
Pilgrim’s Consulting and Engineering departments created a ‘paperless’ traveler for Cubic Defense using SmartSolve. This traveler includes all the needed workflow logic with minimal impact to the end user. The traveler is now in use and has saved Cubic many man hours of documenting data by hand, scanning paper and importing into a database for retrieval at a later date. Data retrieval is now readily accessible as it is located in one central location.

Hall 3
Making SmartSolve® Just for You - Personalizing SmartPortal™
Would you like to personalize SmartSolve® to enhance and ease your user experience? Yes, the latest version of SmartSolve allows you to personalize the portal, query, and other features so that you can view information that is relevant to you without being overwhelmed by non-relevant data at any given time. Learn how to personalize SmartSolve so that you can work more efficiently and effectively.
***Encore presentation on Wednesday at 10:30am in Hall 2

11:35 AM - 12:30 PM

Hall 1
Accept Reality and Take Control - Manage Change across your Enterprise
Managing change can pose a serious challenge due to insufficient support systems for helping organizations make informed decisions and quickly implement such changes. Change Management software can not only help you solve problems today and help you detect problems in the future, but can be a powerful tool for performance monitoring and continuous improvement in the organization.

Hall 2
Supplier Quality in Distribution & Logistics
It is critical to unite Good Distribution Practices (GDP) with other GXP systems to maintain the quality and integrity of products and materials throughout the distribution chain. Discover how GMPs apply to packaging, labeling, storage, distribution, transportation, documentation and record-keeping, and learn which critical controls are appropriate through the requirements and implementation of Good Distribution Practices and the linkages to cGMP, ISO and QSRs.

Hall 3
Automating Risk Management across your Enterprise – Re-engineering Approach to Risk and Compliance
With the complexity of current businesses, increasing risk and regulatory profiles, and the nature of extended and global business, companies need to re-engineer their approach to risk and compliance. Learn how to use Pilgrim’s SmartSolve® solution to manage and sustain risk and compliance practices as part of your company’s overall Enterprise Risk Management. This session will address the identification, evaluation, controls, management and visibility of operational, regulatory compliance and quality risk.

1:30 PM - 2:25 PM

Hall 1
Paving the Way to Life Sciences Regulatory Reporting
Compliant with the reporting requirements of major regulatory agencies, Pilgrim’s medical and adverse event software solution facilitates the entry and assessment of complaints received, preparing the complaint for regulatory reporting - either electronically or via traditional reporting methods. Attend this presentation to learn how to implement automatic easy medical device reporting for (eMDRs) of low- and high-volume submissions to the FDA (MedWatch), as well as EMEA (EU MEDDEV), Canada (TPP), Japan (ARR) and Australia (TGA).

Hall 2
Making Pilgrim Data Accessible through SharePoint
Today’s companies are relying more on knowledge collaboration portals to readily provide access to information for their employees across the enterprise. Through easy-to-use portals, like Microsoft Sharepoint, companies can also share information from their SmartSolve® solution. Come to this session to learn more about integrating SmartSolve and Sharepoint to make SmartSolve documents and content easily available to view within your organization’s collaborative portal.

Hall 3
Optimizing Supplier Quality - Leveraging SmartInspect™
Businesses rely on inspections to maintain their efficiencies. Even a minor breakdown in the supply chain or production, or a slight deviation from quality performance, can cost an organization valuable time and reduce profitability. In this session, inspect Pilgrim’s SmartInspect™ – SmartSolve®’s functionality for receiving, in-process and final inspections. SmartInspect will provide a complete workflow for characteristics used in your inspection criteria to prevent nonconforming products from entering into your production or distribution.
***Encore presentation on Wednesday at 10:30am in Hall 3

2:30 PM - 3:25 PM

Hall 1
Automating Validation throughout the Validation Lifecycle

Hall 2
Implementing An E-Quality System Using Saas (In Less Than 60 Days)
Paper-based systems challenge the ability to remain compliant within regulated industries. This presentation will address the rapid implementation of an easy-to-use SaaS model, the challenges and disadvantages of such a system versus traditional hosted systems, and the barriers to a rapid implementation.

Hall 3
The Latest SmartSolve® Technology Advancements
Attend this session to learn about the latest technology Pilgrim has adapted to give you a true state-of-the-art technical solution. We’re utilizing the latest and greatest technology like Ajax, .net 4.0, table partition, and many more new advancements to enhance the end-user experience and IT administration functions. While attending Fusion 8, this session is the perfect jumping off place to learn the latest technology trend and its usage in SmartSolve.

3:45 PM - 4:45 PM

Creating New Business Apps (Pt. 2): Introducing Pilgrim's New Revolutionary Workflow Engine
Automating new business processes can be a challenge in user adoption. With Pilgrim’s new revolutionary workflow engine, users no longer need to rely upon procedures and work instructions to guide them through any process. Pilgrim’s workflow transforms each workflow step and task into an easy single view of what needs to be performed, where you are in the process, guidance on what are the next steps, and all information easily available from relative tasks such as performed by other users to a complete history of the workflow process itself. In this session, learn how your organization can easily build new workflow processes through a visual user interface including easily defining source input/output for each workflow step, creating tasks, defining rules, assigning forms, and triggering actions such as other workflows, notifications or updating information. Come see this new revolution where the form truly follows the process.
Note: A special SmartDesigner™ bootcamp will be held November 11-12 at Pilgrim’s Tampa Learning Center. Contact Nancy DeFilippis for details.

WEDNESDAY, November 10, 2010

7:30 AM - 8:30 AM

Continental Breakfast / Regulatory Audits & Warning Letters Roundtable Discussion

8:30 AM - 9:25 AM

Hall 1
Using Patient Registries for Improved Comparative Effectiveness
Tracking devices for traceability is a requirement under 21 CFR Part 821/878, however, companies today can go beyond and leverage it as a full patient registry. This session will reveal how, with an automated and integrated Patient Device Registry, companies can streamline their overall data processing and verification, reducing errors in data duplication and improving the overall workforce efficiency and performance for maintaining patient device records. The bottom line – improve marketing and sales effectiveness and build product brand and physician loyalty.

Hall 2
Generating Business User-centric Reports for Q&MIS® – SmartInsight™
SmartInsight™ extends the built-in reporting functionality of Pilgrim’s Q&MIS® platform by allowing system administrators and business analyst users to easily create professional, custom log reports that they can save and reuse. In this workshop you will learn how to gain visibility into all your compliance and quality management data by developing, formatting, and controlling the content, and publishing the reports to the right users.

Hall 3
Technical Optimization & Tuning SmartSolve® for Best Performance
Cars, appliances, computers and more, all require some type of routine maintenance to keep them performing at adequate levels. SmartSolve® is no different. This session will look at tools and techniques used to maintain and even improve the performance of SmartSolve across your enterprise.

9:30 AM - 10:25 AM

Hall 1
Visualizing Your Risk & Compliance Data with SmartPulse™
Leading manufacturing companies need access to vital quality data to attain a 360° view of their quality and compliance pulse across the organization. Reports alone are not sufficient for measurement, analytics, and faster response to decision-making processes. SmartPulse™ provides unique tools for decision makers to explore large quantities of data through a dynamic view of business conditions. Learn how you can keep a “pulse point” on your quality and compliance KPIs through performance measurement.

Hall 2
Understanding Rights and Rights Groups in SmartSolve®
Back by popular demand! Pilgrim’s SmartSolve® System comes with many different types of Rights which can be utilized by administrators, supervisors, record owners, approvers and basic end-users. The objective of this workshop is to help Pilgrim customers gain more insight into the functionality available within of some of these Rights, as well as determine how to utilize these groups more effectively within the Rights Groups assigned to end-users.

Hall 3
Now is the Time: Making the Move from Q&MIS® to SmartSolve®
With Pilgrim’s current and continuing investment into SmartSolve®, many customers are asking important questions such as, “How can I move from Q&MIS® to SmartSolve?” “Can I retain parts of Q&MIS and still connect to pieces of the SmartSolve Suite?” This session will provide recommendations on how to migrate from Q&MIS to SmartSolve, and the current and future integration between these platforms.

10:30 AM - 11:25 AM

Hall 1
Getting Prepared to Move to SmartSolve® Version 9
Miss the webinar? Thinking of upgrading but don’t know what SmartSolve® 9 functionality is all about? Attend this workshop to take a tour of the new features and benefits in this latest SmartSolve release. In addition, learn about the upgrade path and platform certification. Live demo included. This is a must session for those considering an upgrade to SmartSolve 9!
***Encore presentation

Hall 2
Making SmartSolve® Just for You - Personalizing SmartPortal™
Would you like to personalize SmartSolve® to enhance and ease your user experience? Yes, the latest version of SmartSolve allows you to personalize the portal, query, and other features so that you can view information that is relevant to you without being overwhelmed by non-relevant data at any given time. Learn how to personalize SmartSolve so that you can work more efficiently and effectively.
***Encore presentation