& FACILITIES PUERTO RICO INTERPHEX...the USGBC (2:30-3:00) in Booth # 3:30 PM Tour 1: Green...
Transcript of & 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!
4 register todaY at: www.interphex.com/cOnference connect with us: @InterPHeX 5
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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technicaL writing & criticaL thinKing
rM 203
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
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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.
8 register todaY at: www.interphex.com/cOnference connect with us: @InterPHeX 9
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
10 register todaY at: www.interphex.com/cOnference connect with us: @InterPHeX 11
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.
technicaL writing & criticaL thinKing
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
Register today at w
ww
.interPhexPuertorico.com/vanitY
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Connecting a W
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