Medical Packaging Validation Strategies, Planning for Success 2015
14 January, 2015
Palm Beach FL , USA
Overview:
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
Managers
Quality Engineers and Managers
Regualtory Affairs Professionals
Packaging Technicians.
Speaker Profile
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.
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
Managers
Quality Engineers and Managers
Regualtory Affairs Professionals
Packaging Technicians.
Speaker Profile
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.
Organizer
Compliance4All
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Medical Packaging Validation Strategies, Planning for Success 14 January, 2015
