Congress enacted the Drug Quality and Security Act of 2013 (DQSA), formerly referred to as the HR 3204 bill, in November 2013 and it starts to take effect in a significant way in January 2015. You should be planning to attend the 1st annual Serialized Track-and-Trace Seminar on 12th March, 2014. It’s a virtual seminar that allows you to attend the sessions from the comfort of your own home or office, yet you still have access to all the content and experts that you would expect from a live event. It’s a truly unique and valuable opportunity for those focused on these latest changes in legislation for the Pharma industry.

With this latest passing of legislation, it's more critical than ever for you to gain a true understanding of the implications to your business understanding the timeframes for compliance and working through the intersection of the law with SAP based solutions.

Listen to the industry experts providing for an information-packed seminar. Presenters will explore DQSA and what it means to the Pharmaceutical Supply Chain players. Hear what solutions SAP and partners are providing to distributors and manufacturers to successfully implement serialized track-and-trace technology to further secure the safety and security of the healthcare supply chain.

This seminar also offers a unique opportunity to hear from leading solution providers and solution implementors.

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This year’s seminar topics are split in to 2 tracks:

TRACK 1: An executive focus: Understanding the business impact and overall solutions available to you

• What does the Drug Quality and Security Act of 2013 (DQSA), formerly referred to as HR 3204, mean to you?
• What strategies and solutions should you be considering for Supply Chain efficiencies and regulatory compliance?
• Solutions to help with Supply Chain efficiencies for serialized items
• Implementation considerations for global serialization

TRACK 2: A Solution focus: This track focuses on serialized Track and Trace solutions provided by SAP and Inxites

• On overview of SAP's Track and Trace Solution with a focus on SAP EM
• Looking in depth at SAP OER and SAP AII
• Extending SAP's Serialized Track and Trace solution with Verifier Suite
• A detailed look at SAP Global Batch Traceability

Presented by Q Data USA

Supported by TBMG, Inxites, SAP, Pharma Logic Solutions and Auto-ID Consulting LLC

Agenda

Download Seminar Flyer | Abstracts

Track 1 – Executive Focus

Session

Time (PST)

Session Title Speaker 1

8am
to
9am

What does the Drug Quality and Security Act of 2013 (DQSA), formerly referred to as HR 3204 mean to you? On November 27, 2013 H.R. 3204 was signed into US Federal law as the Drug Quality and Security Act of 2013 (DQSA). Among other things, the new law will impact the way prescription drug trades are documented in the United States and preempt state laws for drug traceability, including California’s e-pedigree law. This one hour session outlines the requirements of the DQSA, Title II, referred to as the Drug Supply Chain Security Act (DSCSA). Bill Fletcher 2

9:30am
to
10:30am

What strategies and solutions should you be considering for Supply Chain efficiencies and regulatory compliance? Many countries around the world either have existing or pending laws and regulations to track the movement of prescription drugs in an effort to improve the integrity of their drug supply chain. Life sciences companies are preparing new systems to comply with serialization and traceability. This one hour session will outline the requirements and suggest methods to comply and to gain efficiencies and benefits from traceability. Bill Fletcher 3

12pm
to
1pm

Solutions to help with Supply Chain efficiencies for serialized items SAP has been actively leading the drive towards providing comprehensive serialization solutions dating back to 1999 when they were the first software company to join and collaborate with industry visionaries at MIT’s Auto-ID Center.In recent years, as counterfeit detection and supply chain integrity have climbed to the top of the agenda, SAP is once again leading the way in integrating serialization for track & trace with traditional “back end” ERP processes, evidenced by the fact that the majority of the world’s major pharmaceutical companies are deploying or planning to deploy SAP Auto-ID Infrastructure (AII) and SAP Object Event Repository (OER).This session will outline the business drivers for serialization and cover the SAP solution functionality and the standards that they support. It will also touch on Batch traceability in addition to serial number traceability. Stephen Cloughley and Kevin Wilson 4

1:30pm
to
2:30pm

Implementation considerations for global serialization Implementation of a serialization solution requires a holistic approach and broad view on how the data will be provisioned, captured, managed and disseminated. A phased-based, multidisciplinary and cross functional approach is required to deliver successful results. Building in adaptability and extensibility is key to meeting evolving requirements.This one hour session will explore the many challenges facing serialization projects and key issues and approaches to consider. James Tucker

2:30pm
to
3:00pm

Wrap-Up / open forum – What are your next steps? In this quick wrap-up session we will pull together any open questions and also give an outline of a typical road-map that TBMG follows towards helping interested companies make an informed decision around if and how to implement a serialization solution. Martin Rowan

Track 2 System Focus

Session

Time (PST)

Session Title Speaker 1

8am
to
9am

An overview of SAP’s Track and Trace Solution with a focus on SAP EM SAP’s Track and Trace solution comprises of the following components:SAP Object Event Repository (OER), SAP Auto-ID Infrastructure (AII), SAP Event Management (EM), SAP Global Batch Traceability (GBT). In this session we will cover an overview of each of the components and do a deep dive in to SAP Event Management functionality showing how it can be applied to your business process. We will also dive in to a demo system to show some hands on views of SAP Event Management screens Kevin Wilson 2

9:30am
to
10:30am

Looking in depth at SAP OER and SAP AII These are the 2 main SAP modules providing Track and Trace functionality for serialized items. In this session we will run through the standards that are applicable when talking serialization and in particular Pharma speak. We will also cover the needed architecture together with the scope and functionality covered by each module. After attending this session you’ll have a clear understanding as to what the intended use and scope is for SAP OER and AII. Kevin Wilson 3

12pm
to
1pm

Extending SAP’s Serialized Track and Trace solution with Verifier Suite A serialization project has many nuances to it making it an extremely tricky and complex implementation to handle. In this session we will highlight these complexities and share details on common roadblocks that are encountered. We will also introduce the Verifier Suite of components, developed by Inxites and certified by SAP, that helps bridge the gap for Pharma companies between what is required to gain supply chain efficiencies in your serialized process and what is provided standard within SAP. A typical serialization project approach will be outlined showing what components are needed to be addressed. Guido Rijcken 4

1:30pm
to
2:30pm

A detailed look at SAP Global Batch Traceability The need is out there to be able to understand the reach of a bad batch that is discovered in your supply chain. How can we quickly search the batch genealogy top-down and bottom-up? Can we take those results and see the distribution record and report it to authorities? Can we use that information to affect a targeted recall and limit our exposure?In this session we’ll take an in-depth look at SAP’s solution that covers these questions. You’ll get a detailed look in to what SAP GBT is and what is needed to implement the solution. Stephen Cloughley and Kevin Wilson

2:30pm
to
3:00pm

Wrap-Up / open forum – What are your next steps? In this quick wrap-up session we will pull together any open questions and also give an outline of a typical road-map that Q Data follows towards helping interested companies make an informed decision around if and how to implement a serialization solution. Kevin Wilson

Register today by filling in the form at the bottom of this page – It’s FREE to attend!

Speaker Bios

Download Seminar Flyer | Abstracts

Bill Fletcher Managing Partner
PHARMA LOGIC SOLUTIONS, LLC
Email: bfletcher@pharma-logic.com Mr. William (Bill) Fletcher’s background spans over 30 years in pharmaceutical, enterprise software and healthcare systems. In December 2013, he completed his 21st commercial serialization and traceability project for global life sciences companies, including design, strategy and requirements. He has been recently helping companies implement projects to comply with serialization and tracking regulations around the world, including the recent US Federal Drug Quality and Security Act of 2013 (DQSA), China, EU, Turkey, South Korea, Brazil and others. Mr. Fletcher has received various industry certifications, including SAP Auto identification infrastructure (Aii) version 7.1 and the GS1 Certified Professional (certifying a detailed understanding of barcoding and serialization standards).
Download Bill’s full bio here. Stephen Cloughley Senior Director
SAP Labs LLC
Email: stephen.cloughley@sap.com Mr. Cloughley is a Senior Director at SAP Labs LLC, responsible for Supply Network Traceability. Stephen has responsibility for SAP’s supply network traceability solution as part of its sustainability program, which has SAP Event Management as a key technical component.He came to SAP through the acquisition in 2005 of Lighthammer, where he was part of the leadership team responsible for business development. Prior to Lighthammer, Stephen was President and CEO of Base Ten Systems, Inc., a leader in Manufacturing Execution Systems (MES) for the FDA-regulated industries. Stephen is a chemical engineer from University College Dublin and has over 20 years’ experience in the software industry in Europe, South Africa and the United States. Kevin Wilson ES+ Practice Lead and SAP Solution Engineer
Q Data USA, Inc.
Email: kwilson@qdatausa.comMr. Wilson has more than 24 years’ experience in business analysis, solution architecture, project management, solution development & implementation. 18 years of SAP experience covering supply chain, retail, utilities & manufacturing, amongst others. Business case and value engineering expertise covering multiple, integrated SAP solutions with a strategic focus on Supply Chain Management. Author and thought leader in SAP supply chain execution processes. Download Kevin’s full bio here. James Tucker SAP Serialization and Traceability Expert
Auto-ID Consulting LLC
Email: jt@aieguru.com Mr. Tucker has been referred to as the AIE Guru for his expertise with SAP serialization and traceability solutions, He has seen serialization evolve from its roots in early RFID pilots to today leading global full life cycle implementations leveraging the latest in SAP solutions and best practices.Over the past several years, Mr. Tucker has led major pharmaceutical clients from initial strategic planning through blueprinting and onwards to production implementations. Through this experience, James provides a holistic view to the challenges faced when implementing a serialization program. His broad background in IT strategy and operations, client delivery as well as developing solutions leveraging emerging technologies enables him to provide a cross functional understanding of the obstacles faced when trying to adapt to an ever changing landscape of regulations and requirements. Martin Rowan Managing Partner
The Business Maturity Group
Email: mrowan@tbmginc.com Mr. Rowan’s primary focus is to facilitate solutions that help companies optimize their Integrated Supply Chains to achieve a level of Business Maturity and increase profitability. He is actively involved with local and international ERP markets and has been for over 20 years. His experience covers a wide variety of industries across multiple countries. Some clients he has represented across the globe are BMW, Toyota, General Motors, Mittal Steel, Sanyo, Insight and Asics. Martin holds a Bachelor’s Degree in Engineering and a Master’s degree in Commerce. Guido Rijcken Managing Director
Inxites Americas, Inc.
Email: guido.rijcken@InXites.be Mr. Rijcken is one of the “early days serialization” consultants and has been involved in many serialization projects in many different industries. He has 30 years of ICT/ERP experience focusing on Functional Consultancy, Project Management, Solution architecture, Shop Floor Integration and Execution for Mass Serialization projects.

Download Seminar Flyer | Abstracts