With the growing demand for sterilization of medical devices and pharmaceutical products, the industry is looking to electron beam as a viable alternative to gamma irradiation where appropriate. This webinar will discuss the considerations when evaluating the transfer between gamma and e-beam sterilization modalities. Topics to include Change Assessment, Evaluation of Process Capabilities, Transfer of Sterilization Dose Levels, Product Dose mapping, and Risk Assessment. Regulatory ISO documents 11137 and TIR104 will be used for supporting guidance.
Speakers: Speakers Chad Rhodes – Sterigenics and Jordan Elder – Regulatory Compliance Associates.