March 4-5, 2010 Puerto Rico Convention Center San Juan, Puerto Rico
Education Information
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| Conference Program | |||||||||||||
| Thursday, March 04, 2010 | |||||||||||||
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Sponsored by ISPE: A real case study that summarizes the benefits gained from the application of Risk Based Commissioning and Qualification strategy and ISPE GAMP5 guidelines in a Laboratory Expansion Project. The Scienza Labs Expansion Project in Dorado, Puerto Rico is a successful story that portraits the benefits of integrating the Risk Management Strategies and GAMP applications. Key successful factors in leveraging best practices and applying ASTM E2500, and GAMP5 in a Laboratory project versus the traditional approach.  Speaker: Myrna Orama - Regulatory Compliance Specialist, Pharma-Bio Serv, Inc Nelida Plaza - Vice President of Operations, Pharma-Bio Serv, Inc. | |||||||||||||
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The scope of our presentation will cover the general experiences of Medtronic Cardiac Rhythm Disease Management over the past few years in meeting dual agency requirements for new steroid eluting leads. We will discuss the following topics: Pre-approval Activities: 1. Request for Designation (RFD) to the FDA. 2. Development of pharma compliant analytical methodology 3. Development of pharma compliant drug dose manufacturing technology 4. In-Vitro In-Vivo correlation studies for controlled release products 5. Shelf-life stability studies 6. Upgrades to quality system 7. Pre Approval Inspection (PAI) Post-approval Activities: 1. Manufacturing Readiness 2. Batch records, yield calculations 3. Finished lot testing and retains 4. Lot disposition 5. Annual stability studies 6. Annual product reporting Speaker: Ruben Camacho - Sr. Manufacturing Manager, Medtronic Wilfredo Ruiz-Caban - Sr. Manufacturing Director, Medtronic John Walker - Senior Engineering Manager, Medtronic | |||||||||||||
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Sponsored by ISPE: As new technologies continue emerging in protein expression systems, the ultimate goal of recombinant fermentation processes is achieve high yields and direct processing scalability. Cost-effective production of bio-industrial applications supported by optimized purification procedures must be aligned with the upstream to equalize production capacity. Biotechnology Sessions Sponsored by:  Bacterial hosts are used to express proteins in the form of insoluble inclusion bodies. This lecture expands on the technologies available used to isolate inclusion bodies from bacterial lysates. The effectiveness of this process step sets the start of the downstream steps to follow in the purification train. Real case studies will be detailed based on process development trials conducted to characterize and scale-up this type of application. Process economics considerations will be presented synchronize the technical and the business aspects. Speaker: Gabriel Olmo - Technical & Territory Manager, Pall Biopharm | |||||||||||||
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Greyssi Johanna Campos - Sr Technology Analyst, Wyeth Pharmaceuticals | |||||||||||||
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Jackelyn Rodriguez - President, Monarch Quality Systems Solutions | |||||||||||||
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Scott Sommer, PE, CAP - Automation Manager, Jacobs Engineering Group | |||||||||||||
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Sponsored by ISPE: PAT includes Design, Analysis, Monitoring and Control. The latter is most important for Continuous Quality Verification and Realtime Release, however many manufacturers have difficulty on how to approach this. In this presentation, IBS &ABB will jointly discuss the following strategy to attain Continuous Quality Verification & Realtime Release (CVQ & RTR). a. An overview of regulatory guidelines that describe and stimulate CVQ &RTR. b. The Quality by Design (QbD) steps that enables PAT. c. PAT Data management characteristics d. A case study or demo of PAT Data Management for CVQ & RTR. e. Standards for the Qualification of PAT Control Analyzers. A model will be developed using tools that can provide outputs to the control system to adjus: process parameters in order to obtain the desired results of the CQAs (Critical Quality Attributes) that are being monitored real-timed by on-line instruments and analyzers. With the correct tools, the user can provide the operator with a visualization of where helshe needs to be operating the process within a safe state, defined by your design space of the process. The results allow you to optimize the process to increase yield, increase throughput, reduce costs, and the ultimate goal -to act as a basis for real-time product release (RTPR). This must be accomplished using closely integrated software that is FDA compliant. | |||||||||||||
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manufacturing, or testing medical device products – will provide attendees with a better understanding of the logistical aspects and regulatory requirements associated with the production of medical devices. Lunch will be provided and the presentations will include ample question and answer time. The biocompatibility presentation will cover the principles and guidelines of biocompatibility testing for medical device development. Topics will include risk assessment, materials classification and characterization, ISO 10993 tests for consideration, and test article handling, preparation, and extraction parameters. Speaker: Bill Bradbury - Consultant, WuXi AppTech, Inc. | |||||||||||||
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Biotechnology Sessions Sponsored by: Most pharmaceutical and biotech companies experience some corrosion and rouging of their stainless steel surfaces. Rouge can often be found in high purity water and steam systems as well as process equipment exposed to corrosive environments. There are several factors that can contribute to rouge formation including presence of halides, oxidizing chemistries, extreme pH's, high temperatures, dissimilar metallurgy or defects, improper welding, and inadequate passivation. This presentation will be divided into two parts: Part I will cover the different types of rouge, its formation, and industry practices for derouging and passivating stainless steel, this part will also provide some laboratory generated data (including XPS and Cr/Fe) demonstrating the characteristics and performance of derouging solutions. Part II will focus on presenting case studies including recommendations and procedures at different facilities. Paul Lopolito - Technical Services Specialist, STERIS Corporation | |||||||||||||
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Sponsored by MTLI: For Corrective Action processes to be effective, manufacturers need to look at the process beyond the basic regulatory requirements and recognize the business benefits , not simply compliance. The basic principle requires that we establish the means to self detect and self correct. Is your company struggling with too many CAPAs, an inability to get to root cause, aging CAPAs, CAPA extensions or, failed effectiveness checks?  This session will provide information to avoid these common problems and will give you a new outlook on you Corrective Action process. Examples of best practices will be discussed during the presentation. Speaker: Jim Shore, Boston Scientific | |||||||||||||
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Speaker: David Diaz - Vice President, Operations, ISO Group | |||||||||||||
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To determine the industry’s adoption of the Total Product Life Cycle (TPLC) approach advocated CDRH, Axendia in cooperation with Cambashi and FDANews recently conducted a major research project on this subject. A total of 212 industry insiders from a wide range of medical device and diagnostic companies participated in this research. This session will cover key findings analysis and recommendations from this research study. Attendees will discover: • The current state of product lifecycle management medical device industry • How industry leaders are meeting today’s global challenges • What benefits companies can gain by taking Product Lifecycle approach • Strategies, best practices and information systems to enable this transformation Speaker: Daniel Matlis - President, Axendia | |||||||||||||
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Jackelyn Rodriguez - President, Monarch Quality Systems Solutions | |||||||||||||
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Biotechnology Sessions Sponsored by: Since it’s discovery 25 years ago PCR technology has been widely applied to several different applications ranging from food testing to biodefense. It is gradually making inroads into the pharmaceutical sector. But the big question is: “will the pharmaceutical industry broadly adopt PCR to replace traditional microbiology testing to get faster results?” Presentation will review common concerns and questions with adoption of PCR methods. It will also discuss case study to evaluate the suitability of nucleic acid based systems for pharmaceutical applications. Data will be presented on sensitivity, specificity and accuracy for use in routine pharmaceutical testing with case studies. Speaker: Maitry Ganatra , Pall Life Sciences | |||||||||||||
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Sponsored by ISPE: The new technologies to be covered in the presentation focus on tools to comply with parts: 11, 820, 211, and 600 which covers pharma as well as medical devices, but will better serve industries that need to comply with new regulations since their use will save money on implementation of new regulatory and compliance requirements which are being impacted by the changes. This topic should have special interest for those companies who have to comply with new regulations and those who would like to improve their efficiency and lower the cost of keeping their operations in compliance This seminar will cover the application of coming technologies that will be available for the regulated industry to be in compliance with the 2009 current Good Manufacturing requirements. The new technologies will manage the regulatory aspects, providing a cross link in the documentation control necessary to be in compliance with the new 21 CFR part 11, 820, 211 and 600. New software applications can integrate all relevant requirements and activities necessary to manage in secure databases all different regulatory aspects from the planning, scheduling, implementation, execution and final electronic approval of the documentation in different areas. Several of these areas can be studied and evaluated in an interactive workshop using new technology software database applications that will be released soon: 1. Compliance Level: 21 CFR Part 11, 211, 820 & 600 2. Master Formulas & Manufacturing Instructions 3. Standard Operating Procedures 4. Design Specifications 5. Training Records 6. FDA Submissions 7. Annual Product Review 8. Laboratory of In-Process/Finished Products 9. Laboratory of Raw Materials 10. Laboratory Packaging Components 11. Laboratory Microbiology & Sampling 12. Laboratory of Stability 13. Experimental Projects and Pilot Lots 14. Validation Protocols 15. Media Fills 16. Calibrations and ISO 13485 compliance 17. Re-processing and Non-Conformance 18. CAPA’s, Deviations and Investigations 19. Complaints 20. Returned Goods 21. Recalls 22. QA Audits and Quality Assessments 23. Change Control 24. Retained Samples 25. Advanced Statistics 26. Advanced Custom Reports 27. Manufacturing Scheduling 28. Engineering & Preventive Maintenance 29. P&ID’s Manager 30. Work Orders Manager Speaker: Ramon Cayuela Melendez - Vice President, Computer Integration of Quality Assurance | |||||||||||||
| Friday, March 05, 2010 | |||||||||||||
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The first presentation, “An FDA Compliance Approach to the Detection, Correction and Prevention of Human Errors in Pharmaceutical and Medical Device Operations,” will provide attendees with an understanding of the regulatory rationale behind the investigation process related to human factors. Emphasis will be given to the detection, correction and prevention of human errors during pharmaceutical and medical device manufacturing operations. The second presentation, “From Training to Human Reliability," will discuss the factors that facilitated the successful implementation of a human reliability function within a facility. By rediscovering human nature and controlling variables associated with optimizing human performance, a reduction of more than 50% of the quality events related to human actions has been achieved. Success factors will be discussed. Speaker: Ginette Collazo, PhD. - Industrial/Organizational Psychologist, Ginette M. Collazo, Inc. Johnny Guerra - Industry Consultant/President, Guerra Consulting Group, Inc. | |||||||||||||
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Sponsored by ISPE: Losses associated with poor operation and maintenance cost industry every year. However, the decision to make needed improvements is sometimes based not only on the ability to quantify the value of savings but on the potential impact on the "Validated State" of a system. Improved Operations and Maintenance Programs offer an opportunity to lower costs and increase profits by using existing systems and equipment more effectively. Risk based approaches can enable the use of such existing systems and equipment by lowering implementation costs and avoiding excessive and sometimes unnecessary validation costs. Speaker: Cesar Echevarria - Director of Opertaions , Commissioning Agents | |||||||||||||
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Sponsored by ISPE: The seminar focuses on how to perform an efficient Energy Audit to achieve a good result identifying Energy Conservation Opportunities (ECOs) and to learn how to quantify this Project Savings using simple calculations. Some examples and Case Studies of Energy Conservation projects will be presented as part of the presentation: Systems Evaluations, Lighting, Electrical System, Boilers, HVAC, Compressed Air, Electric Bill Analysis, Preventive Maintenance, etc. Speaker: Ramon Y Pagan - President, PCG Corporation | |||||||||||||
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Speaker: Aileen Barreto - Operations Directoy, LifeScan Products LLC | |||||||||||||
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Sponsored by MTLI: The session participants will learn how to use Process Failure Modes and Effects Analysis (FMEA) to improve the manufacturing process. They will learn how using a pFMEA can identify the critical control points necessary for effective process validation. They will also learn how the pFMEA can assist in continuous improvement of the manufacturing process. In addition to learning about pFMEA, the participate will also learn how the Risk Management process interacts with the other Quality System elements. Speaker: Tracey Holevas - QA Manager - Risk Management, Global Quality Assurance, GE Healthcare | |||||||||||||
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Process monitoring is essential to safeguard product quality, but also for the safety of production operations and the fulfillment of environmental responsibilities. The application of process analytical technology (PAT) brings critical process monitoring to an additional level of control by allowing real-time assessment of product quality attributes, shortening the response time by allowing in-process compensation in parametric trends that enhance product consistency. Moreover, the introduction of PAT tools provides the capability of enhancing the productivity and competitiveness of the pharmaceutical industry by providing data that allows for process fine tuning within the boundaries of the defined design space. The integration of data derived from automated systems and PAT instrumentation provides advantage far beyond the day to day control and monitoring of the process, nurturing the agenda for continuous improvement of processes and enhancing operational efficiency. This real life case study will showcase how data derived from PAT and process automation systems allowed modeling of the manufacturing process at the laboratory level and the eventual implementation of productivity improvements. The focus of the presentation will be in the integration of PAT, Process Control, and IT tools, and how an organization can leverage this information to foster continuous improvement. Speaker: Anthony Potter - Automation Engineer, Lilly del Caribe, Inc. Zainette Ramos - In-Process Analytical Controls (IPAC) Lead Chemist, Lilly del Caribe, Inc. | |||||||||||||
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In a typical initiative to improve overall equipment effectiveness, the starting point is to establish ideal production rates. Ideal capacity, based on planned production, represents 100%. Overall equipment effectiveness (OEE) is the measurement of the final result. It is the cumulative result of the elements that can detract from “perfect production”: availability, performance and quality. Speaker: John Oskin - Executive Vice President, Informance International Hector Rodriguez - Director of Engineering, Lifescan | |||||||||||||
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Scott Beckett - VP Sales & Marketing, EnviroTower | |||||||||||||
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Bob Mehta - Principal Consultant, GMP ISO Expert Services | |||||||||||||
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For many years, flexible manufacturing strategies have been in place for tablet compression and packaging operations. While parallel strategies aren’t being fully utilized yet for production scale coating, several useful concepts are already being widely used on R&D and pilot scale tablet coating projects. This seminar will discuss how proven coating technologies on R&D and pilot scales can be adapted for use at the production scale to achieve manufacturing flexibility and enhanced utilization. Speaker: Edward S. Novit - Coating Product Manager, Thomas Engineering | |||||||||||||
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Sponsored by ISPE: The audience will learn the value proposition in using contract labor to perform proprietary maintenance and support manufacturing operations under cGMP conditions. This case study will illustrate how a flexible work force concept can result in improved productivity and reduce the labor portion of the fixed cost. Presenters will provide their experience and views from the executive suite to the operating floor. For businesses that are experiencing pressure from the corporate headquarters to reduce costs while maintaining vacillating production schedules, this presentation outlines the strategy employed by Fortune 100 companies – to focus on core competencies and outsource non-core task and disciplines. Learn how to analyze the workforce to determine the “low hanging fruit ‘. Participants will take away the critical items to consider when evaluating maintenance contractors. Understand what NOT to do when designing your contracting strategy. The strategies and programs presented on this case study are applicable in a Pharmaceutical, Biotech and Medical Device manufacturing environment. Speaker: Edward W. Foster - CMPR VP, The Mundy Companies Mike Mills - Business Development Manager, The Mundy Companies Colin Orgill - Site Manager, BASF Joe Rettinger - Founder CEO Soliance, Soliance John M. Rocco - Executive VP, Mundy PharmaTech | |||||||||||||
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This actual case study will present the strategic approach followed to transform and renew the organization using LSS principles and mindset & capabilities building. Taking theoretical concepts to a next level with the “Carolina PRo” challenge. Activities that can become best practices examples not only at one company but to the whole pharmaceutical industry. In addition, what elements are needed for a successful deployment and the lessons learned during the continuous journey for improvement. The case study also demonstrates the benefits of people engagement for sustainable results. Speaker: Dorcas Y. Lopez - Strategy & OE Associate Director, Pfizer Jennise Neris - Technology Manager, Pfizer | |||||||||||||
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Sponsored by the USGBC : The USGBC U.S. Caribbean Chapter presented the project as a work in progress, but they just received word from the USGBC that the project was awarded LEED certification. This is significant, in that it is the first pharmaceutical manufacturing facility to attain LEED certification, and the first LEED-EB project in Puerto Rico, and the second LEED certified project in Puerto Rico! The presentation would go over the actual internal process steps to certification along with what to expect after the team submits the project to the GBCI for review, and lessons learned, so that facility teams can start-out on the right track for their certification efforts.  Session Sponsor::  USGBC U.S. Caribbean Chapter can also go over the new LEED-DC and LEED O+M 2009 rating systems so that everyone can familiarize themselves with the latest in LEED. Speaker: Jose Maeso - Executive Director, Pieri Architects Vincent Pieri, AIA LEED AP - Principal, Pieri & Accociates Architects, PSC | |||||||||||||
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