Final Program - Omtec

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Final ProgramAddresses, Educational Sessions/WorkshopsWorkshop: Measurement, Analysis & ChangeControl: The Process Approach to Handling Nonconformances,Feedback, Changes and PossibleHigh-risk ScenariosThursday, June 179:30 a.m. – 12:00 p.m.This session will start by addressing the processes in yourQuality Management System that are used to capture internalas well as external non-conformances and feedback, e.g.complaints, audit findings, adverse events, product failures,process aberrations, etc. Then we will discuss the various waysto handle these results in terms of ensuing changes that couldoccur. Because of this positive and negative feedback, changecontrol must be an integral part of any Quality ManagementSystem. This session is scenario-driven with real life examples,and attendee interaction is the basis for learning what is beingdone when these types of resulting issues are realized.We will address these specific points:• y Installing and implementing a Quality Review Boardas a conduit for further actions• y Using and developing metrics and measurement forManagement Review Sessions• y Controlling change to minimize uncertainties in theQuality Management System• y Listening to customer feedback and understandingwhy complaints are “a gift”• y Implementing the process architecture and linkedrelationships for measuring, analyzing andimproving GMP and ISO-related systems.Attendees will receive these tools to put to immediate use:• y How to develop a Quality Review Board and thelogistics for success• y How to use a risk management file for compliancepurposes• y The corrective and preventive action format forprocess-oriented decisions• y An understanding of process mapping as an asset toyour Quality Management System• y Some approaches to handling this type of sensitiveinformation during FDA inspections and ISO audits• y Management review as a toolBIO: John Gagliardi has had success over the past 40 years inthe medical device and pharmaceutical industries because ofhis practical approach to process-orientation and business. Hisbackground and experience have included active involvementin research and development, quality assurance, operations,process architecture, training and regulatory affairs. John hasspecialized in building systems in these industries that notonly achieve compliance, but are also “business-ready” torealize a profit.Founded in 2000, MidWest Process Innovation, LLC (MPI) helpscompanies develop effective and efficient processes using thearchitecture of ISO 13485:2003, ISO 17025:2005 and the GoodManufacturing Practice/Quality System Regulations.Because process orientation is such an integral part of acompany’s health, MPI has dedicated a segment of its originalcore competencies to transitioncompanies with systems thatrequire a strong regulatory and process-based platform.Workshop: The Toolbox for High Speed Innovationand New Product DevelopmentGregory D. Githens, PMP, NPDPManaging Partner, Catalyst ManagementConsulting, LLCThursday, June 179:30 a.m. – 12:00 p.m.This session will provide useful practices for improving thespeed and effectiveness of innovation programs and strategicinitiatives. Back by popular demand, with new examples!We will address these specific points:• y The large toolbox that can improve the performanceof individuals and organizations• y How to translate vision into results• y The fact that tools help, but don’t replaceorganizational disciplineAttendees will receive these tools to put to immediate use:• y How to construct an elevator pitch that provides acompelling value proposition• y The “what about” tool for surfacing unspokenconcerns and assumptions• y How to clarify roles and responsibilities in theprogram team with the “4 Rs”• y How to turn a marketing spec into a useful technicalspec• y Tips for speeding projects and lowering frustrationBIO: When product development organizations need a “handson” coach who can quickly assess a situation and help getthings moving, they call Greg Githens. Over his twenty-fiveyears of experience in strategic programs and innovation, Greghas developed and acquired practices that address the “crux ofthe matter.” He is skilled at building alignment in people thatenables them to get the tough work done.Greg’s clients have realized the benefits of a more skilledtechnical workforce, improved time-to-market, predictablescheduling, better metrics, better strategic alignment,outstanding design concepts and improved decision making.Page 142010
Final ProgramAddresses, Educational Sessions/WorkshopsA recognized authority, Greg has spoken to many high-profilegroups and authored over three dozen articles, papers andbooks on the topic. Greg holds advanced degrees in businessand science, and is a certified Project Management Professionaland a certified New Product Development Professional.Workshop: Product Development Metrics forManufacturers: Measuring your ProductivityBradford L. Goldense, NPDP, CMfgE,CPIM, CCPPresident, Goldense Group, Inc.Wednesday, June 169:30 a.m. – 12:00 p.m.Wall Street still values organic innovation over all other forms ofproduct development innovation. Companies with “inventionengines” have highly favorable market capitalizations. This wasthe focus of my OMTEC 2009 session. The world is always movingforward. And, time builds experience. Open Innovation (OI), tosome level for every company, is now inevitable. As a “bodyof knowledge,” OI is maturing. Certain corporate behaviorsnow have patterns, with somewhat consistent approaches, andsome risks are known. Wall Street doesn’t yet know how tovalue everything that is OI, but that will come.We will take a snapshot of the “State of Open Innovation” incorporations. OI is not the major product development trendto pay attention to, however. It is part of a triad that includescontracted-out innovation and product or technology sale orlicensing. These three industry activities all place the “corporatejewels of innovation,” the Intellectual Property (IP), outsideof the owning corporation to some level. Companies arestruggling to protect themselves at these unprecedented levels.As this IP becomes more commoditized, Wall Street will figureout how to value it all. The arms-length sale and exchange ofIP is already in nascent stages in public marketplaces. The firstsix great generations of innovation will be explained to precedea focus on the seventh and next great generation of corporateinnovation, “IP-Based.” This is a quantitative presentation.Many facts, figures and studies will be cited.2010Page 15
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