European User Conference Munich | 7 April - 10 April ...d284f45nftegze.cloudfront.net/trackwise/abstracts EMEA.pdf · 3 EMEA User Conference | Munich 7 - 10 April Message from the

Sparta Connection 2014European User ConferenceMunich | 7 April - 10 April

SPARTAconnection

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Sparta Connection 2014

Please find the event agenda, workshop descriptions and pertinent details for your convenience.

If you require any assistance, please contact an event representative at the Sparta Connection information desk, located in the Foyer Erdgeschoss, or call:

Alicia Brown1.646.287.6605

Michele Stoddard1.732.496.9863

* Please remember to wear your Sparta Connection badge at all times.

Welcome

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EMEA User Conference | Munich | 7 - 10 April

Message from the CEO

It is our pleasure to welcome you to Munich for Sparta Connection 2014 – our 6th Annual European User Conference.

This year we celebrate twenty years of quality management innovation. In that time, the world of quality management has experienced a tremendous amount of change. This change will continue and occur at an ever faster rate as manufacturing operations and regulatory requirements become increasingly more global and complex and as technology innovation changes quality management practices. Today, more than ever, effective quality management is not only a strategic imperative for all manufacturing companies but also a means of competitive differentiation.

We are excited to bring inspired quality management professionals together to share best practices and examine current and future trends. We are pleased to share with you our new innovative quality management solutions and provide a glimpse into future solutions. At this event, you will see first-hand how predictive analytics will enable proactive quality management and how mobile solutions are enabling greater effectiveness and efficiency. Moreover, you will see how our new cloud solution, Stratas, is extending quality management and control into the supply chain.

On behalf of Sparta Systems, I’d like to thank each of you for your loyalty, time and dedication, not only this week, but throughout the year.

Regards,

Eileen MartinsonChief Executive OfficerSparta Systems, Inc.

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Agenda

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Monday, 7 April

Pre-Conference Training Fischer

Registration Westin Lobby/ Sheraton Foyer Erdgeschoss

Welcome & Kickoff Christian Rockwell, Vice President, Global Marketing, Sparta Systems Cuvillies

CEO Keynote Eileen Martinson, Chief Executive Officer, Sparta Systems Cuvillies

R&D Update Bruce Kratz, Vice President, Products, Sparta Systems Cuvillies

Cocktail & Welcome Reception Sheraton Biergarten Sponsored by TAKE Solutions

BreakfastWestin

RegistrationSheraton Foyer Erdgeschoss

Product Roadmap & Showcase Product Management, Sparta SystemsCuvillies

Quality Presentation Jim Attardi, President, Technical Resource DynamicsCuvillies

8:00 – 16:00

12:00 – 17:00

16:30 – 16:40

16:40 – 17:00

17:00 – 17:30

18:30 – 20:30

7:00 – 8:45

7:00 – 9:00

9:00 – 9:45

9:45 – 10:15

Tuesday, 8 April

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Tuesday, 8 April

BreakFoyer Erdgeschoss Sponsored by HighPoint Solutions

Workshop Session 1

Effner I, II & Cuvillies Effner I, II & Cuvillies Effner I, II & Cuvillies

Implementing Stratas: Extending the Quality System

Beyond the Four Walls

The Sparta Technical Advisory Offering

Case Study: Managing User

Adoption within an Organization

Workshop Session 2


Extending Your EQMS into Regulatory

Affairs with Product Registration Tracking

Recalls - The best recall is the one you

never have to do

EQMS and Regulatory

Intersection - What are the keys unlocking value

and meeting requirements

Lunch Outdoor Foyer Erdgeschoss Sponsored by INCONSULT

Workshop Session 3


Supply Chain Visibility - What impact does an

EQMS have on your Supply Chain

Getting the most out of your Sparta

Support

European Regulatory Changes and the

Impact on US Medical Device Manufacturers

10:15 - 10:45

10:45 – 11:45

12:00 – 13:00

13:00 – 14:00

14:00 – 15:00

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BreakfastWestin

Keynote Speaker Dr. Nigel Croft, Chairman, TCA GlobalCuvillies

Quality in the High-Tech and Discrete Manufacturing Industry David Brown, Director, Quality Management, Emhart Glass Cuvillies

Break Foyer Erdgeschoss Sponsored by HighPoint Solutions

7:00 – 8:45

9:00 – 10:00

10:00 - 10:30

10:30 - 11:00

Wednesday, 9 April

Tuesday, 8 April


Workshop Session 4


TrackWise and Vault QualityDocs: Integrating Quality

Processes and Documents

The Future of TrackWise: 9.0 and

Beyond

Case Study: The Benefits of

Regulatory Tracking in TrackWise

Table Topics Networking Outdoor Foyer Erdgeschoss

Free Evening

15:00 – 15:30

15:30 – 16:30

16:45 – 17:45

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Workshop Session V


Changing the Boundaries on

Conducting Audits with TrackWise Audit

Execution Package

Discovering Hidden Insights: Advanced

Self Services Business Intelligence

Case Study: Utilizing the Customer Success Program to Enhance Your Business Insight

Lunch Outdoor Foyer Erdgeschoss Sponsored by INCONSULT

Workshop Session 6


Advancing TrackWise Analytics: Predictive

Analytics and Unstructured Text

Analysis

Upgrading Made Easy

Case Study: Planning for Global

Implementation: Configuration Strategies for

Organizing Information within

TrackWise

Workshop Session 7


TrackWise Analytics Applied in Practice

Case Study: Handling Product Corrections

and Removals within TrackWise

Accelerating TrackWise

Deployment with Sparta’s Quick

Implementation Packages

11:00 – 12:00

12:00 – 13:00

13:00 – 14:00

14:15 – 15:15

Wednesday, 9 April

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Breakfast-to-go Westin

Post-Conference Training Sheraton Fischer

7:00 – 9:00

9:00 - 12:00

Thursday, 10 April

Wednesday, 9 April


Customer Presentation Sandoz or BiogenCuvillies

Closing Cuvillies

Tour Bavarian National Museum

Farewell EventBNM RestaurantSponsored by Process Stream

*Lobby departure time 17:30

15:15 – 15:45

15:45 – 16:15

16:15 - 16:45

18:00 – 19:00

19:00 – 23:00


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Workshops

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Speaker Title CompanyBarbara Bruno RA Database Operations Novartis V&DBen Shectman Director, User Experience Sparta SystemsBrian Brzezinski Team Lead Sparta SystemsCeline Coantic Quality Software Project Leader bioMerieux Dave Hartmann Product Manager Sparta SystemsDavid Brown Director, Quality Management Emhart GlassGal Barnea Operational Manager, EMEA Sparta SystemsJames Attardi President TRDJamie Chumas Program Manager Sparta Systems Jay Smith Director, Product Management Sparta Systems Joby George Technical Product Manager Sparta Systems Julia Winterhalder Customer Engagement Manager Sparta SystemsJustin Matthews Global Operations Manager Sparta SystemsKarin Thrane Quality Application Manager Coloplast Kelly Kuchinski Industry Solution Director Sparta SystemsKR Karu Industry Solution Director Sparta Systems Marie-Pierre L. Quality Software Project Leader bioMerieuxMohan Ponnudurai Industry Solution Director Sparta SystemsNancy Singer Founder Compliance-AllianceOrit Magyar Head of Quality Process Application Coloplast Peter Arvidsson Systems Owner, TrackWise Getinge Prathiksha Oghra Global Head of Technology Management Biogen Robert Weiss Customer Engagement Manager Sparta SystemsSagie Twig Solutions Consultant Sparta SystemsShay Van Creveld Customer Engagement Manager Sparta SystemsTanja Brenek Global Process Manager ColoplastTim Jones Application Manager Novartis AG Tom Rac Global Manager, Technical Advisory Sparta Systems

Workshop Speakers

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Tuesday, 7 April | Session 1

Workshop 1 - CuvilliesImplementing Stratas: Extending the Quality System Beyond the Four WallsSparta

Listen as we discuss how to extend supplier quality management from a business process perspective. We will also review a guided tutorial on the new innovative Stratas solution.

Workshop 3 - Effner IICase Study: Managing User Adoption within an OrganizationBioMerieux

Obtaining organizational readiness, user adoption and change management are key elements for any efficient software roll out. Listen as BioMerieux describe the tools they put in place to support TrackWise users to drive user adoption, proficiency and productivity.

Workshop 2 - Effner IThe Sparta Technical Advisory OfferingSparta

Hear the elements of what the Technical Advisory Offering is and how it can help your company with. (I.e. scalability, implementation effectiveness, whitespace analysis).

T

T

B

B = Business Workshop T = Technical Workshop

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Workshop 1 - CuvilliesExtending Your EQMS into Regulatory Affairs with Product Registration TrackingSparta

Managing product registrations with dozens of regulatory agencies, each with their own requirements, can be a challenge. Join us as we demonstrate how the TrackWise solution enables companies to track the full lifecycle of the product registration process so they can bring product to market with greater speed and efficiency while maintaining compliance with global regulatory bodies.

Workshop 3 - Effner IIEQMS and Regulatory Intersection - What Are the Keys Unlocking Value and Meeting RequirementsSparta

Regulations are changing and evolving at the same time the cost and margin pressures are increasing in all industries. The connection between quality and compliance has never been more critical. Learn how TrackWise addresses regulatory reporting challenges and delivers regulatory reporting solutions to meet key needs such as eMDR, eMDV, UDI.

Workshop 2 - Effner IRecalls - The Best Recall is the One You Never Have To DoSparta

In an effort to reduce costs, Brand Owners are outsourcing most of the manufacturing and packaging and relying on more global suppliers to reduce costs and stay competitive. But the complexity of this global vendor network provides little to no visibility into the procedures and processes used in developing finished goods. This increases the risk to the brand owner, the brand itself, and most importantly the consumer. Attend this session to discuss the levels of risk and the associated potential accelerating issue resolution costs. Learn where issues happen, how they can impact the company, and how EQMS can help companies reduced that risk through automated quality processes and real-time updates from outside vendors.

B

B

B


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Workshop 1 - CuvilliesSupply Chain Visibility - What Impact Does an EQMS Have on Your Supply Chain, and Why is it Important?Sparta

Listen as we outline how quality problems or inefficiencies along the supply chain can cost companies money and impact revenue. We will review how an EQMS can address these supply chain issues, which includes better management/correction of problems with an organization’s value delivery chain, better visibility into the supply chain challenges to prevent problems from happening, and better supplier quality management.

Workshop 3 - Effner IIEuropean Regulatory Changes and the Impact on US Medical Device ManufacturersTUV & Sparta

European medical device regulations are changing and the impact on the US Medical Device manufacturers is significant. Learn the consequences of the EC recommendations in the areas of audits and new scrutiny on clinical data and software controlled medical devices with respect to patient safety. Learn how to demystify these new requirements and tips on how medical device manufacturers can succeed in the European market.

Workshop 2 - Effner IGetting the Most Out of Your Sparta SupportSparta

Review the levels of TrackWise support that are available to you the user community and discuss best practices for leveraging this critical offering.

B

B

T


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Wednesday, 8 April | Session 4

Workshop 1 - CuvilliesTrackWise and Vault QualityDocs: Integrating Quality Processes and DocumentsSparta

Sparta Systems and Veeva Systems, Sparta’s preferred partner for enterprise content management, will discuss the vision for a jointly supported integration between TrackWise and Veeva’s Vault QualityDocs. We will explore the Vault QualityDocs solution and how the integration will work to provide value to customers in the area of change management.

Workshop 3 - Effner IICase Study: The Benefits of Regulatory Tracking in TrackWiseNovartis AG & Sparta

Join Novartis V&D as they discuss their ‘Registration Tracking System’ (or RTS) in TrackWise. Hear how this global regulatory affairs process tracks Novartis’ marketing authorization application lifecycle from dossier submission to approvals to renewals and is being used by over 100+ users located around the globe.

Workshop 2 - Effner IThe Future of TrackWise: 9.0 and BeyondSparta

This technical workshop will review how Perrigo has leveraged TrackWise Web Services to integrate their global change control process with a variety of other systems. They will demonstrate how web services helped provide a closed-loop process to contribute key assessment information such as products, licenses, sites of manufacture and more.

B/T

T

B


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Workshop 1 - Cuvillies, Effner I & Effner IIChanging the Boundaries on Conducting Audits with TrackWise Audit Execution Package, TrackWise Analytics and StratasSparta

Conducting service provider and supplier audits offers a critical view of their systems and compliance with operational and business procedures. Observations and findings from these audits can be used to build a foundation for risk management and help align audit resources and manage compliance risks. Learn how to build a solution to consolidate data collection from various disconnected systems for audits, observations, and CAPAs into TrackWise EQMS and streamline the supplier quality management.

Workshop 3 - Cuvillies, Effner I & Effner IICase Study: Utilizing the Customer Success Program to Enhance Your Business InsightColoplast & Sparta

Understanding how your quality management solution is being used across the various manufacturing locations, processes and job functions in your business and understanding how certain quality management process metrics within your business stack up against others in the industry using similar processes is invaluable information. Hear how Coloplast and Sparta Systems used the new Customer Success Program to evaluate and greatly enhance the business value of their TrackWise system. Learn the results of the assessment and their key takeaways.

Workshop 2 - Cuvillies, Effner I & Effner IIDiscovering Hidden Insights: Advanced Self-Service Business IntelligenceSparta

This interactive workshop will walk through the creation of advanced reports and charts using TrackWise Analytics. We will also take a sneak peek at some new types of innovative reports and visualizations coming soon to TrackWise Analytics including custom maps and cluster charts.

T

B

T


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Workshop 1 - Cuvillies, Effner I & Effner IIAdvancing TrackWise Analytics: Predictive Analytics and Unstructured Text AnalysisSparta

Introducing advanced capabilities coming to TrackWise Analytics. Learn how your company can harness existing data to predict the likelihood of an event occurring, such as a device failure or a recall. We will also explore various methods of performing analytics on unstructured text data from TrackWise systems to help determine trends and patterns.

Workshop 3 - Cuvillies, Effner I & Effner IIUpgrading Made EasySparta

Listen as we debunk the scary myths of upgrading your current TrackWise system and why you will want to upgrade! We will review Sparta’s packaged upgrade offerings available today and provide clear definition on whom and what is supported.

Workshop 2 - Cuvillies, Effner I & Effner IICase Study: The Business Side of an ERP IntegrationColoplast & Sparta

Hear how Coloplast successfully streamlined a nonconformance process by integrating their TrackWise and ERP systems. They will discuss the challenges they faced when assumptions were made during the integration and how to avoid them. They will also share their successes and lessons learned during the process and where they are now.

B/T

B

B


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Workshop 1 - Cuvillies, Effner I & Effner IITrackWise Analytics Applied in PracticeSparta

Join us for an overview and demonstration of TrackWise Analytics, Sparta’s advanced ad-hoc reporting and analytics solution. We will then take a look at a real example of how TrackWise Analytics is being leveraged to drive business outcomes at a pharmaceutical company. The discussion will include building the business justification, current usage and future plans, validation approach, and the value TrackWise Analytics has brought to the organization.

Workshop 3 - Cuvillies, Effner I & Effner IIAccelerating TrackWise Deployment with Sparta’s Quick Implementation PackagesSparta

Our solutions delivery methodology is designed to deliver holistic, enterprise quality management solutions based on aggressive timelines. Combining industry-standard system development lifecycle (SDLC) practices with rapid application prototyping (RAP) enables us to deliver solutions tailored to your company’s unique quality, compliance and regulatory needs. Listen as we discuss Sparta’s QIPs (Quick Implementation Packages) and how they can help accelerate deployment of key functionality for companies wishing to leverage our best practices approach.

Workshop 2 - Cuvillies, Effner I & Effner IICase Study: Handling Product Corrections and Removals within TrackWiseGetinge Infection Control AB & Sparta

In this workshop Getinge will discuss a new workflow they created to comply with FDA’s 21 CFR 806 and how the process handles all product corrections and removals potential, initiated and performed within their company. Hear the in-depth information on how and what the process covers.

B

B

T


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Access the TrackWise ExpertsDuring all breaks, please visit the exhibition area to meet members of Sparta Systems Product Management, Education, Support and Services teams.

Meet with the team and schedule one-on-one sessions. Access to our subject matter experts will provide insight on how to leverage and scale your TrackWise investment, how to maximize Sparta Systems’ support and services, and learn about new training offerings.

Sponsors


Platinum Sponsor

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Gold Sponsor

a-tune software AGJulius-Reiber-Strasse 15

64293 DarmstadtGermany

t: +49 6151 95131 0f: +49 6151 95131 29e: [email protected]

a-tune software AGyour partner forProcess and Workflow Management

We speak the language of our customers - in German, English, French, Biology, Chemistry and other...

The a-tune advantage

Data and process management for R&D (Biology, Chemistry and Life Science)

Worldwide projects from our offices in Germany, UK and the US

Process and workflow management for R&D

tick@lab - Lab Animal & Facility Manage-ment Software

make IT simple.

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Silver Sponsor

a-tune software AGJulius-Reiber-Strasse 15

64293 DarmstadtGermany

t: +49 6151 95131 0f: +49 6151 95131 29e: [email protected]

a-tune software AGyour partner forProcess and Workflow Management

We speak the language of our customers - in German, English, French, Biology, Chemistry and other...

The a-tune advantage

Data and process management for R&D (Biology, Chemistry and Life Science)

Worldwide projects from our offices in Germany, UK and the US

Process and workflow management for R&D

tick@lab - Lab Animal & Facility Manage-ment Software

make IT simple.

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Notes

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Notes

Corporate OfficeSparta Systems, Inc.2000 Waterview Drive, Suite 300Hamilton, NJ 08691(888) 261-5948(609) 807-5100 [email protected]

Europe OfficeSparta Systems Europe, Ltd.1 Hachoshlim St.Herzliya, Israel 46724+972 9 970 [email protected]

Asia Pacific OfficeSparta Systems, Inc.31, Rochester Drive, Level 24 Singapore 138637 +65 [email protected]

www.spartasystems.com