Individuals responsible for medical packaging system design and validation are required to provide a safe and effective packaging system that can deliver the enclosed product to the end-user without incurring defect or risk to patient safety.
The scope of this webinar is to provide those responsible for medical device packaging system design with some key best practices and insights for the design and development of the medical packaging system, sterile barrier system. ISO 11607 part 1 will be the focus, ISO 11607 Part 2, equipment and process validation, will not be addressed.
The following seven design essentials will be presented and the author will provide her perspective on how these seven essentials are key to success and efficient time to market for your medical device.
Areas Covered in the Session:
Seven Essentials for Successful Medical Packaging Design
Packaging Design Requirements
Packaging System Hazard Analysis
Evaluation of similar or competing devices
Clinical application of the Sterile Medical Device
Distribution, storage and handling of the medical device
Prototype the packaging system
Package System Performance Testing
Who Will Benefit:
Medical device Packaging Engineers
Quality Engineers and Managers
Regualtory Affairs Professionals
Karen K. Greeneis currently Vice President, Life Packaging Technology LLC, a packaging engineering consulting and services firm. She has been a packaging engineering industry professional for over 30 years. Ms. Greene holds a Bachelor of Arts, Biology, degree from Holy Cross College in Worcester, MA and a professional certificate in engineering management from University of CA, San Diego. She is a certified packaging professional, CPP, the Co- President of the southern California Chapter of the Institute of Packaging Professionals and is a committee chairperson of the IoPP Medical Device Packaging Technical Committee. Ms. Greene is a member of the ASTM F02, Flexible Barrier Packaging committee. She is an ISTA 7E (thermal design and validation) certified auditor.
Ms. Greene is a lead industry consultant for medical device and pharmaceutical package development, validation and production implementation projects and has solved problems related to sterile barrier package integrity, package design, test method development and test method validation and packaging quality related issues. Her expertise extends to cold chain packaging issues, as well. She has held leadership positions with Edwards Lifesciences and IMED Corporation for teams responsible for packaging engineering, documentation, configuration management and label development functions within the medical device industry.
Ms. Greene is sought after for her expertise in developing action plans for compliance to international packaging regulatory standards as well as solving packaging performance problems. She has authored several articles, presented at numerous conferences and conducted webinars on the topic of medical packaging, statistical rationale development for packaging validations and packaging integrity issues.