I am the owner and founder of PackWise Consulting with 30+ years experience in package engineering with foods, pharmaceuticals, detergent, and medical devices. My work has included individual contributions and leading teams for packaging material and systems design/development to meet regulatory, product protection, and customer use requirements.
My work includes packaging system validations, cold chain shipping, several types of sterilization methods, production line efficiency increases, packaging equipment, and sustainable packaging, as well as documentation procedures, policies, and project management with multiple packaging materials types and production lines.
Over the last 20 years, I have worked in the medical device industry with European (EU)/FDA/Japanese and other countries’ requirements. I was a task group leader for the AAMI TIR 22 document–a U.S. guidance document on compliance with the ISO/EN 11607-1 & -2, Terminally Sterilized Medical Device Packaging; the document has been adopted as ISO TIR 16775. I am, also, a member of the ASTM D10 and F2 (rigid and flexible packaging) groups that develop industry standard test methods and guidance, and the IoPP Southern California chapter revitalization group.
The companies I have worked for include:
- Abbott Vascular/Guidant Corporation
- Dade Behring/Syva
- Lever Brothers
- ConAgra/Hunt Wesson Foods
- Bristol-Myers Squibb/Mead Johnson
My contact for working with your company is: jan@packwiseconsulting.com.