& facilities puerto rico interphex...the usgbc (2:30-3:00) in booth # 3:30 pm tour 1: green...

INTERPHEX Puerto r ico

CONFERENCE PROGRAM

OctOber 4-5, 2012Puerto rico convention center • san juan, Puerto rico

www.interPhexPuertorico.com/vanitYhere

MORE INdustRIEs thAN YOu KNEw 4 shOws. ONE EVENt!

P U E R T O R I C O P U E R T O R I C O& FACILITIES

2 register todaY at: www.interphex.com/cOnference connect with us: @InterPHeX 3

ricardo acosta, Director | Global Logistics IT Merck

vanessa alvarado guevara, HR Training and Organizational Development Senior Manager | CooperVision

victor Batista, General Manager | Pfizer Carolina

josé a. caraballo, Director of Validation | Amgen

Lourdes m. de cárdenas Ph.d., Vice-President of Operations, Latin America | Stryker Global Quality and Operations

nelson a. Flores jr., Director of Special Events, Puerto Rico Manufacturers Association

manuel garcia, IT Quality Assurance Director | MMM Holdings, Inc.

Fernando gonzalez, Vice President | ISPE Puerto Rico Chapter

ricky gutierrez, President | ISPE Puerto Rico Chapter

eugenio a. Longo, Executive Director, BioCED Corporation

ivan Lugo, Executive Director | INDUNIV Research Consortium

norma Mejia, President | PRTEC.

Francisco martinez, Office and Business Developer Manager | Fluor

nelson Perea, Executive Director, PRTEC

juan Perez, President & Principal Consultant | Quality Computer System Validations, Inc.

carlos soto, Plant Manager | NP Caribe

carlos tollinche, Director Scientific Affairs | INDUNIV Research Consortium

ricardo clinton, Manufacturing Manager | Roche Diagnostics

nestor contreras, IT Operations Leader | BD – Information Technology

rey cordova, Quality Control Manager | Bulk, Lilly del Caribe, Inc.

david diaz, Vice President | Operations, ISO Group

Luis martinez, IT Manager | Integra Life Science

justo o. moreno, Executive Director | Information Systems, Amgen Manufacturing Ltd

INTERPHEX Puerto Rico brings together four shows under one roof.Join thousands of industry colleagues for two days of education, sourcing and networking.

conference advisory Boardexhibit hall hours:Thursday, October 4 - 1:00 PM - 8:00 PMFriday, October 5 - 1:00 PM - 7:00 PM

create Your Personal agenda “my interPhex show Planner”As you read through the conference brochure take note of sessions you don’t want to miss. You can add them to your personal agenda at www.interphexpuertorico.com/myagenda. You will also be able to:• Preview the floorplan• Search Exhibitors by show, company name, and product

category• Preview Exhibitor announcements regarding new

equipment, products or services they’re bringing to the show

• Request appointments with specific exhibitors• Add Conference Sessions that you plan on attending• Take note of special events you don’t want to miss

table of contentsConference Advisory Board.............4

P U E R T O R I C O

The Caribbean’s premier event covering the full spectrum of pharmaceutical and biotechnology manufacturing.

The island’s most trusted source for innovation and collaborative opportunities in the field of high-tech precision medical device manufacturing.

P U E R T O R I C O& FACILITIES

Puerto Rico’s meeting place, most trusted platform and source for products and technical information that drive sustainability through cost efficiency and energy saving Green Buildings for Commercial, Industrial, Residential, and Institutional Facilities.

Produced by the Multi Sectorial Alliance, is a comprehensive showcase of supply chain, logistics and distribution technologies and solutions.

Exhibit HallSee a complete list of exhibitors for each show at www.INTERPHEXPUERTORICO.com/exhibitors.

Conference AccreditationAll of the sessions will be accredited by the CIAPR for CEU credits. Each contact hour means 0.1 CEU.

Register Early and SaveBy registering early you can save up to $100. See the back page of this brochure for more details. Register online at: www.interPhexPuertorico.com/conference

neWhours!


tracKPharma/Bio tracK

rm 202amedicaL device tracK

rM 202bBuiLdings & FaciLities

rM 202c

technicaL writing & criticaL thinKing

rM 203

Latin america suPPLY chain

9:00 AM

Applying Technical Writing Principles and Critical Thinking

to Regulated Documents

10:00 AM - 11:00 AM

Product Development Panel Product Development PanelLooking Ahead: The Future of

the Puerto Rico Energy Industry

For details visit www.LASupplyChain.com

11:15 AM - 12:15 PM

Plenary Session Greening Hospitality Properties

12:15 PM - 1:15 PM

Lunch

1:15 PM - 2:15 PM

Quality Panel Quality Panel Assessing and Mitigating Risks

in Green Building Projects

2:30 PM - 3:30 PM

Facility Panel Manufacturing Panel

The Transformative Mission of the USGBC (2:30-3:00)

in Booth #

3:30 PM Tour 1: Green Hospitality, the Sheraton Convention Center

Hotel and CasinoPuerto Rico Concention Center

Lobby3:45 PM - 4:45 PM

Manufacturing Panel

4:45 PM - 6:00 PM

EPA/LEED Awards and Cocktail Reception

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Latin america suPPLY chain

suB-tracKProduct development

rm 202aFacility

rm 202bProduct development

rm 201b

For details visit www.LASupplyChain.com

9:00 AM - 10:00 AM

Verification of PAT Enabled Control Systems

Process Design Initiatives to Reduce Cost of Goods

Combination Product Development

EPA Sustainability Tools for Puerto Rico

Applying Technical Writing Principles and Critical Thinking

to Regulated Documents

10:15 AM - 11:15 AM

Integrating Pharmaceutical Development into Design Control for Convergent Medical Products

Challenging the Manufacturing Paradigm of Biomanufacturing

Drug-Device Combination Product Development - INDs for

Device Companies

Retro-Commissioning for Existing Facilities

11:30 AM - 12:30 PM

Effective Qualification and Delivery of All Things

Pharmaceutical

Using Enabling Technologies and Methods to Develop and

Manufacture Biopharmaceuticals

Process Development in the Medical Device Industry

Greening Existing Buildings Case Studies in Puerto Rico

12:30 PM - 1:30 PM

Lunch

SUB-TRACKQuality

rm 202amanufacturing

rm 202bQuality

rm 201bmanufacturing

rm 201aBuildings & Facilities

rm 202c

1:30 PM - 2:30 PM

Proven Processes and Metrics to Optimize Operational Excellence

Quality Metrics as a Tool for Management Responsibility

Using OEE to Improve Production

Renewable Energy Solutions

2:45 PM - 3:45 PM Practical Applications of

Statistical Methods Under 2011 FDA Process Validation Guidance

Incorporating PAT Methods into Production Recipes for Real

Time Release

CAPA System for Medical Devices Leaning Batch Record

Documentation & Work Flow Before Implementing EBR

The Transformative Mission of the USGBC (2:45 - 3:15)

In Booth #

3:30 PM Tour 2: The State Historical Preservation Office (SHPO)

Puerto Rico Concention Center Lobby4:00 PM -

5:00 PMA CMO Approach to The 2011

FDA Process Validation GuidanceAutomated Lifecycle Approach to

Validation Process

Effective Cleaning Procedures for Medical Devices Using

Laboratory Studies


medicaL deviceProduct development

combination Product development

Friday, October 5, 9:00am – 10:00amVenky Gopalaswamy Ph.D., Vice President, Johnson & Johnson

Define Combination products and their uses Explain differences/ similarities in developing combination products vs. medical devices.Share ideas on how to successfully develop, manufacture and commercialize a combination product.

drug-device combination Product development - inds for device companies

Friday, October 5, 10:15am – 11:15amDavid Armbruster,Global Program Manager, Synthes Biomaterials

The importance of understanding IND submission requirements early in the development processThe need to leverage external consultants to supplement internal capabilities for critical tasksThe importance of understanding market value relative to development costs including clinical trials

Process development in the medical device industry

Friday, October 5, 11:30am – 12:30pmEric F. Davila, Sr. Engineering Manager, Medtronic

Product trends influencing process development.Technology trends influencing process development.Industry and global challenges influencing the medical device industry.

QualityQuality metrics as a tool for management responsibility

Friday, October 5, 1:30pm – 2:30pmElizabeth Staub, Vice President Regulatory Affairs & Quality Assurance, Stryker

The role of metrics in the Quality System and Management Review.Kinds of metrics - quality and compliance, process and result.Forums, formats, and goal setting to drive improvement

caPa system for medical devices

Friday, October 5, 2:45pm – 3:45pm Robert Sestrick, Design Controls Manager -Global Quality, GE Healthcare

Understand the use of CAPA in a Quality Management SystemUnderstand the fundamentals of the CAPA processDevelop an understanding of a compliant CAPA system to 21 CFR 820

effective cleaning Procedures for medical devices using Laboratory studies

Friday, October 5, 4:00pm – 5:00pmElizabeth Rivera, Technical Service Specialist, STERIS

Critical factors affecting the cleaning of medical devicesLaboratory evaluation: why and howCleanliness criteria based upon sampling method and pre-established limits

manufacturingusing oee to improve Production

Friday, October 5, 1:30pm – 2:30pmAdrian Pask, Management Analyst, Vorne Industries

The critical role of consultants in project planning and to supplement internal capabilities.

Leaning Batch record documentation & work Flow Before implementing eBr

Friday, October 5, 2:45pm – 3:45pmChuck Krumwiede, Vice President, Malcom Associates

Importance of leaning the documentation and work flow before implementing EBRValidate and invalidate system user requirements specifications (URS)Understanding process/documentation requirements before developing the URS

Pharma/BioProduct development

verification of Pat enabled control systems

Friday, October 5, 9:00am – 10:00amManuel Hormaza, President, IBS Caribe, Inc.

having trouble deciding which conference track to attend?Pharma/BioProduct DevelopmentFormulation scientist and engineers, quality assurance and CSV engineers, technology transfer technicians will also benefit from this track. Additionally professionals involved in the commissioning and qualification of pharmaceutical equipment, instruments and facilities will find this informative and enlightening.

QualityRecommended for quality directors, plant managers, manufacturing managers and vice presidents of operations who are responsible for operational excellence, quality control and assurance, regulatory affairs and process validation. Team members currently involved in quality initiatives will benefit as well.

FacilityKey for operations and quality managers and department heads responsible for strategic capacity and facility planning for the next generation of products, including biosimilars. Process science and development engineers, facility engineers and project managers and those involved with project that aim to achieve facility flexibility will gain valuable knowledge.

ManufacturingCritical for manufacturing managers and directors in the pharmaceutical, biotech, medical device and other regulated manufacturing companies with responsibilities in the following areas: manufacturing quality, R&D, scale up, PAT, operational excellence, validation and IT.

medicaL deviceProduct DevelopmentInstrumental for project managers, scientist, engineers and regulatory professionals responsible for the development of drug-device

combination products. In addition, managers whose responsibilities include product development strategy for medical devices will gain valuable knowledge.

QualityTargeted to positions and disciplines in quality assurance and quality control as well as professionals involved in product release testing. Key for engineering, manufacturing and validation personnel responsible for the manufacturing or continuous improvement of medical devices.

ManufacturingUseful for managers, directors and above who are responsible for quality, operations, project management and IT. Operational excellence, continuous improvement, maintenance, engineering and operations managers or directors and those interested in improving manufacturing or packaging performance will benefit from this track.

BuiLdings & FaciLitiesBuilding owners and operators, contractors, designers and risk managers who are looking for orientation on implementing the latest and most cost effective green building design, construction and operations strategies at their properties and how to manage the inherent risk to green buildings. In addition, financial offers interested in learning about the business case for transforming their existing facility into an energy efficient, ecologically effective “green building”.

TECHNICAL WRITING & CRITICAL THINKINGProfessionals from quality, technical services, EHS, engineering and production areas who create, review or approve technical documents.


Learn to apply new standards to PAT Qualification ProjectsSupport implement RTRT strategyLearn the European approach to PAT Model submission requirements

integrating Pharmaceutical development into design control for convergent medical Products

Friday, October 5, 10:15am – 11:15amRoy R. Fennimore Jr., Research Fellow, Product & Process Scientific Solutions- A J&J Company

What can be leveraged from Technology Transfer (TT) Processes and BenchmarkingHow to Integrate Pharmaceutical Development Practices into a Design Control SystemWhat are the key deliverables and take-aways for Technology Transfer Guidelines

effective Qualification and delivery of all things Pharmaceutical

Friday, October 5, 11:30am – 12:30pmBlaik Jensen, Associate Quality Engineering Consultant, Eli Lilly and Company

List the source documents that feed the User RequirementsDescribe how using commissioning to reduce the qualification riskState the differences between delivering a Development Facility and a Manufacturing Facility

QualityProven Processes and metrics to optimize operational excellence

Friday, October 5, 1:30pm – 2:30pmShane Yount, Principal / Author, Competitive Solutions, Inc.Ed Dubeau, Director and Team Leader of Manufacturing for Consumer Healthcare Operations, Pfizer

Learn to establish expectations and auditing procedures to drive measurable resultsLearn to execute an action plan that directly impacts each echelon of the organization

Practical applications of statistical methods under 2011 Fda Process validation guidance

Friday, October 5, 2:45pm – 3:45pmAbe Germansderfer, Associate Director, QCTS and Statistics, Gilead Sciences

Setting Process Validation Acceptance Criteria with Statistical Tolerance IntervalsAdopting Acceptance Sampling Plans to Determine Validation Sampling Requirements

a cmo approach to the 2011 Fda Process validation guidance

Friday, October 5, 4:00pm – 5:00pmSandra Lueken, Director of Quality, Baxter Pharmaceutical Solutions LLC

Implement an integrated team approach to process validation.Understand the CMO’s role in the product lifecycle and responsibilities.View a case study and example of knowledge management over a product lifecycle history.

FacilityProcess design initiatives to reduce cost of goods

Friday, October 5, 9:00am – 10:00amHector T. Davila, Director Process/Specialty Engineering, Fluor, Inc.

Review Key contributors to Cost of Goods on a ManufacturingReview Process Alternatives to COGS reductionStimulate participants to find innovative methods of production with COGS in mind

challenging the manufacturing Paradigm of Biomanufacturing

Friday, October 5, 10:15am – 11:15amJeff Odum ,Director of Operations, IPS – Integrated Project Services

Discussions on the drivers to achieve flexibility while meeting regulatory requirements.

using enabling technologies and methods to develop and manufacture Biopharmaceuticals

Friday, October 5, 11:30am – 12:30pmMark Witcher, Principal Consultant, IPS – Integrated Project Services

Why poor performance of the biopharmaceutical industry requires new approaches and facilitiesHow enabling technologies and regulatory approaches can be used to launch productHow advanced designs in manufacturing facilities can greatly improve the performance

manufacturingProven Processes and metrics to optimize operational excellence

Friday, October 5, 1:30pm – 2:30pmEd Dubeau, Director and Team Leader of Manufacturing for Consumer Healthcare Operations, PfizerShane Yount, Principal / Author, Competitive Solutions, Inc.

Learn to establish expectations and auditing procedures to drive measurable resultsLearn to execute an action plan that directly impacts each echelon of the organization

incorporating Pat methods into Production recipes for real time release

Friday, October 5, 2:45pm – 3:45pmChristopher Amstutz, Director Life Sciences Industry Consulting, Emerson Process Management

Considerations when integrating PAT methods into shop floor recipesMethods of integrating PAT methods into shop floor recipesWhat’s needed when batch reporting shop floor recipes with integrated PAT methods

automated Lifecycle approach to validation Process

Friday, October 5, 4:00pm – 5:00pmSiva Samy, Chief Product Strategist, ValGenesis, Inc

Indentify the painpoints associated with the paper based manual validation processValidating the benefits of an automated approach to validation lifecycle processDiscuss how an electronic validation approach enables the closed-loop quality process

BuiLdings & FaciLities

Looking ahead: the Future of the Puerto rico energy industry

Thursday, October 4, 10:00am – 11:00amModerator: Maria Judith Oquendo, President, Puerto Rico Energy Cluster, Inc.

Panel Members: Dr. Javier Quintana, PE, Dean of School of Engineering, Universidad Interamericana de Puerto Rico; Engineer Arturo Galletti, Vice President,CSA Architects and Engineers, LLP; Engineer Wilfredo Walters, Vice President, Empresas Intec, Engineer Gaspar Bonet

greening hospitality Properties

Thursday, October 4, 11:15am – 12:15pmJose Juan Terrasa, PR Tourism; Dr. Fernando Abruna, FAIA

The aim of this presentation is to review the Puerto Rico Tourism Operations Guidelines for Eco-Tourisim Hospitality destinations. The guide includes sections on design and development, greening existing Hotel destination operations, and an overview of how the guidelines enable hotel owners to apply for the 2011 Puerto Rico Building and Operations Code “permiso verde”.

assessing and mitigating risks in green Building Projects

Thursday, October 4, 1:15pm – 2:15pmGuillermo Luis, Marsh Saldana; Vincent Pieri, AIA LEED AP

While the benefits to the environment and community, owner, contractor and designer are undisputed, there can be significant challenges with identifying specific risk exposures inherent in sustainable building design, construction, and facility operations. This presentation enables participants to address risk exposure by outlining key green building risks and risks management strategies with a focus on contractual and insurance related issues from the perspective of owners, contractors, and risk managers. Case studies and best practices for minimizing green building risks will also be shared

the transformative mission of the usgBc

Thursday, October 4, 2:30pm – 3:00pmAn exhibit floor presentation by the USGBC U.S. Caribbean Chapter

The presentation is an overview of the USGBC, their transformative vision and mission, the LEED, green building rating system, how the USGBC U.S. Caribbean Chapter is executing the mission of market transformation in Puerto Rico and the Caribbean region, and how you can get involved.

green Building tour 1

Thursday, October 4, 3:30pm

Green Hospitality, the Sheraton Convention center Hotel and Casino is the first major LEED building in Puerto Rico and the first LEED certified Sheraton hotel in the world.

ePa Presentation

Thursday, October 5, 9:00am – 10:00am


retro-commissioning for existing Facilities

Friday, October 5, 10:15am – 11:15am Cesar Echevarria, Commissioning Agents, Inc.

Commissioning is an essential tool for optimizing energy performance. The process ensures that all building systems perform interactively according to the design intent and the owner’s operational needs. The commissioning process can be applied to existing buildings that have never been commissioned to restore and maintain optimal energy performance.

greening existing Buildings case studies in Puerto rico

Friday, October 5, 11:30am – 12:30pmEnrique Vila Biaggi, PE Professional Office Park; Marel Del Toro, Cuartel Ballaja

The case studies presented by building owners and facilities managers in Puerto Rico who have experienced the transformational potential, and practicality of greening their existing facilities. Their stories make the business case for greening existing buildings in Puerto Rico, and the benefits derived from doing so using the LEED green building rating system.

the transformative mission of the usgBc

Friday, October 5, 2:45pm – 3:15pm An exhibit floor presentation by the USGBC U.S. Caribbean chapter

The presentation is an overview of the USGBC, their transformative vision and mission, the LEED, green building rating system, how the USGBC U.S. Caribbean Chapter is executing the mission of market transformation in Puerto Rico and the Caribbean region, and how you can get involved.

green Building tour 2

Thursday, October 5, 3:30pm

The State Historical Preservation Office (SHPO) in Old San Juan is beginning the LEED-EB O+M certification process for the Cuartel Ballaja, their 155 year old headquarters in Old San Juan. The Cuartel Ballaja was the last Spanish Army barracks built in the Western Hemisphere, and is a beautiful example of Spanish colonial architecture. The renovations included a new HVAC system and controls, lighting retrofit, a 150 KVA Photovoltaic Array, and a 25,000 sf vegetated “green roof”. Learn how the project elegantly integrates the latest sustainable design technologies and historic preservation.


applying technical writing Principles and critical thinking to compliance documentation

Thursday and Friday, October 4-5, 9:00am – 5:00pmEliezer Ramos, Consultant and Instructor at BioPharma Training ServicesRoberto A. Pomales, Consultant and Instructor at BioPharma Training ServicesRosaura Ortiz, Consultant and Instructor at BioPharma Training Services

Know how the technical writing process support the reduction of audit findings and observations, recurring problems and cycle timesLearn how to improve the critical thinking through the use of problem solving and root cause analysis toolsApply technical writing principles to create effective written documents

MYS Blurb about add these sessions to your agenda

special eventsBuildings & Facilities mainstageBuildings & Facilities Show FloorThursday and Friday, October 4-5, 1:00pm – 6:00pm

Various events and presentations by influential industry groups and organizations will take place at the brand new Buildings & Facilities mainstage. See a detailed event listing online at: www.interphex.com/events

one-on-one meeting centerShow Floor Thursday and Friday, October 4-5

Opportunity for you and your team to meet one-on-one with exhibitors in a private meeting area

ePa/Leed awards and receptionBuildings & Facilities MainstageThursday, October 4, 4:30pm – 6:00pm

opening night receptionThursday, October 4, 7:30pm – 9:00pm

Open to all badge holders

networking hourShow FloorFriday, October 5, 6:00pm – 7:00pm

Open to all badge holders

industry association meetingsWe have built close partnerships with various groups, associations, clusters and alliances that will be holding meetings at INTERPHEX Puerto Rico. Meetings are by invitation only. Please contact your group for meeting details.

•PRMA•PRTEC•EnergyCluster

•PuertoRicoProductsAssociation•USGBCCaribbeanChapter•JonesLangLaSalle

Register Early and Save!

Early Bird Onsite Before 9/4 After 9/4

Exhibit Hall Pass................................................................... FREE

$50*

*10/4-10/5Full Conference Pass.............................................................

$495

$595One Day Conference Pass.....................................................

$295

$395Governm

ent / Academia Full Conference Pass...................... $245

$245

*Must show

Govt. ID badge

Buildings & Facilities Conference Pass Only Full Pass............................................................................ $295

$395

One Day Pass.................................................................... $195

$295 Technical W

riting & Critical Thinking Workshop Only

Full Pass............................................................................ $295

$395 Student Full Conference Pass............................................... $50

$50

*Must show

student ID badge

Groups (4 or more) Full Conference Pass............................. *Call for pricing

*Call Alycia Grenesko at 203-840-5897

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