Independent Consultant
Quality Specialist
Regulatory Compliance Associates Inc.
Quality Engineer and Specialist
Ge Healthcare 2010 - Jul 2012
Global Capa Manager, Healthcare It
Autpro Consultants 1998 - 2008
President
Regulatory Compliance Associates Inc. 2004 - 2008
Director of Integrated Systems Validation
Education:
Devry University
Skills:
Capa Quality System Medical Devices Validation Fda Design Control Quality Management V&V Quality Assurance Gmp Quality Auditing Six Sigma 21 Cfr Part 11 Cross Functional Team Leadership Iso 13485 Iso 14971 Change Control Automation Pharmaceutical Industry Lean Manufacturing Software Documentation Computer System Validation Dmaic Sop Supplier Quality Root Cause Analysis Quality Control Fmea Manufacturing R&D Continuous Improvement Testing Green Belt Process Improvement Product Development Iso Design of Experiments Glp Process Engineering Biomedical Engineering 21 Cfr Program Management Integration Management Process Simulation Regulatory Requirements Lifesciences Manufacturing Operations Leadership
Languages:
English
Certifications:
Private Pilot Airframe & Powerplant Certification Iso 13485 Auditor Cisco Academy Instructor Federal Aviation Administration
Andrew D. Aswad - Mundelein IL Dale Severs - Gurnee IL Joyce Silvestri - Antioch IL Hugh M. Forman - Waukesha WI Lecon Woo - Libertyville IL Thomas D. Hiller - Vernon Hills IL Lisa S. Walsh - Wonder Lake IL Sandra Wade - Highland Park IL Eddie Chan - Mundelein IL Patrick Balteau - Namur, BE Franco Peluso - Heverlee, BE Eric Henaut - Nivelles, BE
Assignee:
Baxter International Inc. - Deerfiled IL
International Classification:
A61B 1900
US Classification:
604403
Abstract:
An improved adaptor and protector for same which is removably sealing an opening of the adaptor located at an end of a tubular member. The adaptor has a longitudinal passageway for receiving a cannula. An upper end of the adaptor has an interior diameter defining a first end of the passageway for receiving the cannula. A lower end of the adaptor has an interior diameter defining a second end of the passageway adapted for receiving an injection site wherein the diameter of the first end is larger than the diameter at the second end. A middle portion intermediate the first end and the second end has a tapering interior diameter for directing the cannula to the injection site and further having an exterior surface with gripping surfaces. The tapering interior diameter of the middle portion of the adaptor includes guiding members to direct the cannula or other injection devices. The adaptor may also be provided with a protector removably sealing an opening located at an end of the adaptor.
A system and method is provided which substantially eliminates the effect of air entrapped in tubing for delivering a liquid from a container. The inner diameter of the tubing is selected such that the gravitational force of the liquid from the container is greater than the surface tension of the liquid. A release agent may be used as a coating layer on the interior wall in addition to or alternatively from an expanded diameter.
Dale R. Severs - Gurnee IL David Frankenberger - Mountain Home AR Richard Williams - Norfork AR Michael Kemp - Mountain Home AR
Assignee:
Baxter International Inc. - Deerfield IL
International Classification:
B31B 184 B31B 164
US Classification:
493210
Abstract:
An apparatus (31) and a method are disclosed for performing an operation upon multiple webs (51,53), including the feeding of multiple webs (51,53), the provision of a carrier (65) for assisting in moving the webs (51,53) along a predetermined path (83), the performance of an operation (69) upon the webs, the insertion of a carrier (65) between the webs (51,53), and the provision of a sealing device (71) for sealing the webs together to form a sealed portion (75) to cooperate with the carrier (65) for assisting in moving the webs (51,53). The carriers (65) are mounted on a conveyor (83) and each carrier (65) pushes against the sealed portion (75) to pull the webs (51,53), and the packages (41) formed therefrom in the direction of conveyor travel. The preferred carrier (65) has a shaped head on the end of a flat plastic blade. The shaped head may have an opening (81) therein of a smaller size than the sealer (188) inserted into the opening such that the fused plastic may extrude outwardly to abut the edge (79) of the carrier defining the opening.
Port Adaptor And Protector And Container Having Same
Andrew D. Aswad - Mundelein IL Dale Severs - Gurnee IL Joyce Silvestri - Antioch IL Hugh M. Forman - Waukesha WI Lecon Woo - Libertyville IL Thomas D. Hiller - Vernon Hills IL Lisa S. Walsh - Wonder Lake IL Sandra Wade - Highland Park IL Eddie Chan - Mundelein IL Patrick Balteau - Namur, BE Franco Peluso - Heverlee, BE Eric Henaut - Nivelles, BE
Assignee:
Baxter International Inc. - Deerfield IL
International Classification:
A61B 1900
US Classification:
604403
Abstract:
An improved adaptor and protector for same which is removably sealing an opening of the adaptor located at an end of a tubular member. The adaptor has a longitudinal passageway for receiving a cannula. An upper end of the adaptor has an interior diameter defining a first end of the passageway for receiving the cannula. A lower end of the adaptor has an interior diameter defining a second end of the passageway adapted for receiving an injection site wherein the diameter of the first end is larger than the diameter at the second end. A middle portion intermediate the first end and the second end has a tapering interior diameter for directing the cannula to the injection site and further having an exterior surface with gripping surfaces. The tapering interior diameter of the middle portion of the adaptor includes guiding members to direct the cannula or other injection devices. The adaptor may also be provided with a protector removably sealing an opening located at an end of the adaptor.
Sungwook Yang - Deerfield IL Dale R. Severs - Gurnee IL David Frankenberger - Mountain Home AR Michael Kemp - Mountain Home AR
Assignee:
Baxter International Inc. - Deerfield IL
International Classification:
B31B 184
US Classification:
493212
Abstract:
An apparatus (31) and a method are disclosed for temporarily separating multiple webs (51,53) while performing an operation (123,125,133) thereon, including the feeding of multiple webs (51,53), the provision of a retractable web separator (68) for temporarily separating the webs, the performance of an operation (123,125,133)) upon the webs, the provision of a gripping device (65) for gripping the webs and assisting in moving the webs (51,53) along a predetermined path (83), and the provision of a sealing device (71) for sealing the webs together to form a package seal (73). The retractable separators (68) are mounted on a conveyor (83) and each separator (68) in turn temporarily separates the webs (51,53), for insertion of a port (45), fitting or the like, whereupon the separator (68) may be retracted and the port (45) may be sealed into the packages (41) being manufactured. The preferred separator (68) has a shaped head (170) on the end of a reciprocating shaft (158). The head (170) may be enlarged and may have a tapered end (171) for insertion between the webs (51,53).
A system and method is provided which substantially eliminates the effect of air entrapped in tubing for delivering a liquid from a container. The inner diameter of the tubing is selected such that the gravitational force of the liquid from the container is greater than the surface tension of the liquid. A release agent may be used as a coating layer on the interior wall in addition to or alternatively from an expanded diameter.
Dale Severs 1972 graduate of Grant Community High School in Fox lake, IL is on Classmates.com. See pictures, plan your class reunion and get caught up with Dale and other high school alumni