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The CRO Group is participating in the following EVENTSThe ASQ Biomedical Division presents PROCESSES, AND PRODUCTS A two-day Seminar with Workshops Monday and Tuesday, October 22 and 23, 2007 Embassy Suites Baltimore at Baltimore/Washington International (BWI) Airport Join experts from government, industry, and academia for the latest thinking on the application of risk management to medical device businesses and related topics. Gain insight into recent, important changes to regulatory standards and guidance for enterprises, products, and processes. This comprehensive seminar presents risk management concepts used throughout the business including the quality system and the lifecycle of the product, from design...to manufacturing... through post-production. Topics will include: Enterprise and Business Risk Management Communicating Product and Compliance Risks to Top Management The important changes to GHTF approaches to Risk Management The important changes to IEC 60601 The important changes in MEDDEV 2.12-1 rev 5, MEDICAL DEVICES VIGILANCE SYSTEM The important differences in ISO 14971:2000 and 14971:2007 Using Risk Management to Improve Software development and deployment TIR-32 Risk Management in Production and Process Control Risk Management in Outsourcing, Purchasing Controls, and Acceptance Activities Integrating Risk Management in Complaint Handling and in CAPA Risk Management Tools including FTA, FMEA Confirmed Speakers include: Kimberly Trautman, Quality Systems Expert, CDRH, FDAAlf Dolan, Associate Professor, University of Toronto Kenneth Imler, Vice President RA/QA, Arrow International Angelo Scangas, Quality Support Group, Inc. Oliver Christ, General Manager, PROSYSTEM AG Andre Routh, Ph.D., Sr. Product Expert, BSI Product Services-Healthcare Bill McLain, Principal Consultant, Keystone Regulatory Services, LLC Glen Emelock, The CRO Group, Inc. Pam Goldstein, GI Dynamics Debbie Iampietro, QRC Associates Paul Meixner, Thomas Medical Products, Inc. F. David Rothkopf, MEDIcept Special one time pricing for this event, Save $200, register before September 14:ASQ members $ 595, Forum and non-members $ 795 Click here and join ASQ as a full member for $125 and SAVE Event Price includes Breakfast, Breaks, Lunch, Presentation Handouts, and a copy of TIR-32 Medical Device Software Risk Management
CUSTOM SEMINARSISO 13485:2003, CanMDR/CMDCAS and Advanced MDD/IVDD CE Marking Seminar At your company, Call or fax 1-888-881-5637 or email us at info@crogroup.com for availability and price, or click here for more info. ISO 14971:2007, Medical Device Risk Analysis Seminar At your company, Call or fax 1-888-881-5637 or email us at info@crogroup.com for availability and price, or click here for more info.
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