Dose Mapping Requirements – Understanding the Historic and Current Practices

Available on Demand until July 19, 2018

 
Historically, the Medical Device/Pharmaceutical/Biologics industry has experienced inconsistencies with respect to Gamma PQ Dose Mapping requirements for product deemed as sterile according to ANSI/AAMI/ISO standards.

Healthcare products have dramatically evolved over time, and are less likely to be homogeneous in composition.  Along with new combination products, material composition and packaging have made it necessary to place dosimeters within the product box in order to measure the minimum dose.  As a result, there is a requirement for triplicate dose mapping in order to measure the dose distribution and assess the process variability.


This Webinar will help clarify historical practices and current practices and guidance with respect to Gamma PQ Dose Mapping.


Speakers:

Niki Fidopiastis, Director, SteriPro Consulting, Sterigenics

 
Niki Fidopiastis has served the field of Medical Device and Pharmaceuticals/biologics Sterility Assurance for 27 years. Niki Joined Sterigenics International in 1998 as the primary consultant for SteriPro Consulting (EO and Radiation). Her expertise in Medical devices and Pharmaceuticals sterilization been honed through experience and practice in both in sterilization processing and laboratory testing. Prior to joining Sterigenics, Ms. Fidopiastis served nine years with North American Science Associates (NAMSA) where she held various laboratory supervisory positions.

 

Kevin O’Hara, Director, Radiation Physics, Sterigenics


Kevin is a Radiation Physicist with corporate responsibility for measurement and calculation of absorbed dose associated with the radiation treatment of product, such as sterilization of healthcare instruments. I am highly motivated, and enjoy working with customers. I am an applied computational physicist with almost 30 years of experience in radiation physics and radiation dosimetry within a highly technical industry. Kevin is actively involved in industry committees, task forces and working groups. As a Working Group member, Kevin represents Canada on ISO TC 198 WG 2 Radiation Sterilization.

 



 


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