Monday, August 31, 2009
Background
Package Engineering expertise includes more than twenty-seven years within the medical device/pharmaceutical industry and approximately four years within general consumer product areas. The last sixteen years have been as a Consultant with Farron Associates.
My Package Engineering background is diversified. It includes individual package design and Packaging system development, project management, testing and labeling. However, because much of my experience has been within the medical device/pharmaceutical industry, my background also includes special skills in the following areas: Sterile package validation, seal integrity, asceptic transfer, shelf-life studies, cold-chain distribution cycles, clinical trial packaging as well as an in-depth knowledge of National and International standards and regulations.
Package Validation and Analysis
- Responsible for audits conducted to identify package system problems and cost reduction opportunities. After identifying and recommending alternative actions, managed programs to implement more effective designs and manufacturing approaches. All programs were administered in accordance with recognized methods and standards.
- Extensive experience in writing and executing package validation protocols. Protocols have included test standard/method application, test results evaluation and interpretation as well as corrective action recommendations and implementation.
- Reviewed and appraised internal package documentation systems and outlined improvements to supply chain management.
Package Design, Materials and Process
- Recommended packaging material/equipment/manufacturing systems, managed implementation and supervised testing applying sound environmental and economical approaches as well as meeting FDA and International Standards.
- 18 years experience in the design of thermoformed package components.
- Developed and tested package systems for the transport of thermally sensitive and hazardous materials.
- Designed and managed lebeling system projects that addressed product characteristics/brand differentiation, International labeling and bar ciding requirements.
Credentials and Affiliations
- Certified Packaging Professional (CPP) with the Institute of Packaging Professionals
- Degrees: California State University and University of Redlands
- Memberships: IOPP (Institute of Packaging Professionals), ASTM (American Society for Testing and Materials), OCRA (Orange County Regulatory Affairs)
If you have an issue that requires the expertise of a Package Engineering Professional, contact Farron Associates and ask for Sharon Jaeger.
949-582-2239 farron2@mindspring.com
949-582-2239 farron2@mindspring.com
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