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Medical Packaging Validation Strategies, Planning for Success
Compliance to ISO 11607, Parts 1 and 2 require that Packaging Sterile Barrier Systems and Packaging Processes be validated. Validation planning is key to success. Inadequate planning will result in delayed time to market and ultimately financially negative impacts. Attend this webinar to obtain tangible and practical strategies and tactics for a successful medical packaging validation that you can put to immediate use.
Learn the differences of various distribution simulation industry standards and reasons why one methodology and testing approach may be indicated over another. You will have the opportunity to question the presenter who is a subject matter expert on packaging validations and medical package testing.
Areas Covered in the Session:
- Package testing and regulatory compliance
- Validation Strategy
- Protocol development
- Sample development
- Package design validation vs. Process Validation
- Testing Methodologies and Testing Standards
- Wrap Up and Review
Who Will Benefit:
- 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.
There may be many networking opportunities at the Medical Packaging Validation Strategies, Planning for Success. Find out more in the event details below.
Quality Engineers and Managers
Regualtory Affairs Professionals
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