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:
Who Will Benefit:
- 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
- Medical device Packaging Engineers
- Quality Engineers and Managers
- Regualtory Affairs Professionals
- Packaging Technicians.
Karen K. Greene is 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.
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