Goode Compliance International Jan 1, 1993 - Dec 2017
President
The George Washington University School of Medicine and Health Sciences Jan 1, 1993 - Dec 2017
Adjunct Faculty
Institute of Validation Technology (Ivt) Jan 1, 1993 - Dec 2017
Managing Editor
Institute of Validation Technology 1998 - 2014
Editorial Advisory Board Member
University of Miami 2009 - 2014
Chair, Industry Advisory Board
Education:
Mit Sloan School of Management 2011 - 2015
University of Miami 1986 - 1991
Master of Science, Masters, Biomedical Engineering
University of Miami 1984 - 1986
Bachelors, Bachelor of Science, Medicine
Palm Beach State College 1982 - 1984
Associates, Associate of Arts, Biology
Skills:
Fda Iso 13485 Medical Devices Quality System Design Control Capa Validation V&V Biomedical Engineering Design of Experiments Quality Assurance Six Sigma R&D Fmea Gmp Manufacturing Minitab Cross Functional Team Leadership Product Development Leadership Biotechnology Regulatory Affairs Lean Manufacturing Quality Auditing Auditing Testing Engineering Root Cause Analysis Glp Sop Training Laboratory Commercialization Sterilization Quality Control Spc Quality Management Risk Management Biocompatibility Clinical Research Technology Transfer Process Validation Warning Letters Statistical Techniques Statistics Lifesciences Corrective Actions Medical Device Directive Compliance
Interests:
Six Sigma Medical Device Design and Manufacturing Risk Management Lean Critical Thinking Photography Statistics Business Modeling Astronomy
Languages:
Spanish English
Certifications:
Executive Certificate In Management and Leadership Certified Quality Engineer License Cvtrust-26986470100 Mit Sloan Executive Education, License Cvtrust-26986470100 Asq, License 33581 License 33581
Lawrence A. Weinstein - Davie FL Roberta D. Goode - Miami FL
Assignee:
Cordis Corporation - Miami Lakes FL
International Classification:
A61M 500
US Classification:
604167
Abstract:
A catheter introducer comprises a tubular sheath having an axis, and a housing carried on one end of the sheath. The housing encloses a fluid-filled chamber and carries a pair of valves aligned along the axis, the valves being at opposed ends of the fluid-filled chamber and communicating therewith. The valves serve to substantially retain the fluid within the housing, while allowing a catheter to pass through the valves and through the tubular sheath. The fluid of the chamber is preferably a gel or high viscosity liquid. The valves and fluid-filled chamber prevent the backflow of blood both in the presence and the absence of a catheter or the like extending through the valves and chamber.
Raymond C. Franzel - Miami FL Roberta D. Goode - Miami FL
Assignee:
Cordis Corporation - Miami Lakes FL
International Classification:
A61M 500
US Classification:
604256
Abstract:
A catheter introducer defines a tubular sheath with a housing on one end thereof, with the housing enclosing a fluid-filled, elastic-walled toroidal member defining a central aperture aligned with the tubular sheath axis. The central aperture is normally closed, being retained in the closed position by an elastic sleeve carried by the toroidal member. The central aperture is penetrable by a catheter in sealing manner as the catheter is advanced through the catheter sheath introducer.
Roberta D. Goode - Miami FL Lawrence A. Weinstein - Davie FL
Assignee:
Cordis Corporation - Miami Lakes FL
International Classification:
A61M 5178
US Classification:
604167
Abstract:
A valve comprises an elastomeric partition member having first and second opposed faces, the valve being adapted for securement in a housing. Typically, one or both of the faces define a recess of substantially rectangular cross section to reduce the central thickness of the partition member, the recesses being wider than they are deep. The elastomeric partition is typically made of an elastomer having an elongation of 900 to 1500 percent, a tensile strength of at least 11. 5 megapascals, a Shore `A` durometer of preferably 45 to 70, and a tear strength of at least 150, as determined by tests described herein. Significant improvements are achieved by slit partition valves which utilize the elastomeric partition member of this invention.
Hemostasis Valve For Catheter Introducer Having Thickened Central Partition Section
Lawrence A. Weinstein - Davie FL Roberta D. Goode - Miami FL
Assignee:
Cordis Corporation - Miami Lakes FL
International Classification:
A61M 5178
US Classification:
604167
Abstract:
A hemostasis valve for a catheter such as a catheter sheath introducer comprises an elastomeric partition extending across an aperture in a hub carried by a catheter. The partition defines an annular, peripheral area which is secured to the hub. The partition further defines a second area positioned radially inwardly from the peripheral area. The second area is of substantially less thickness than the peripheral area. The partition further defines a central area positioned radially inwardly from the second area, the central area being of substantially greater thickness than the second area, and defining a slit therethrough to permit passage of the elongated member.
Roberta Wilburn 1963 graduate of Westinghouse High School in Pittsburgh, PA is on Classmates.com. See pictures, plan your class reunion and get caught up with Roberta and other ...