March 4-5, 2010 Puerto Rico Convention Center San Juan, Puerto Rico
Education Information
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View Sub-Track: Sessions on Quality | |||||||||||||
| 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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Jackelyn Rodriguez - President, Monarch Quality Systems Solutions | |||||||||||||
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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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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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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 | |||||||||||||
| 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 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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