MD&M East

Process Validation Prerequisites 101

Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...
Nature

Retrospective validation of genomic biomarkers – what are the questions, challenges and strategies for developing useful relationships to clinical outcomes – workshop summary

The material presented in this article is a consensus opinion reached by the authors, which summarizes opinions and views shared during the DIA-FDA-PWG-PhRMA-BIO Pharmacogenomic workshop on ...
ascopubs.org

Retrospective Validation and Clinical Implementation of Automated Contouring of Organs at Risk in the Head and Neck: A Step Toward Automated Radiation Treatment Planning for ...

We assessed automated contouring of normal structures for patients with head-and-neck cancer (HNC) using a multiatlas deformable-image-registration algorithm to better provide a fully automated ...
PharmTech

Process Validation in Biologics Development

Process validation is an extension of biologics development processes. When it comes to outsourcing process validation of biologics, Abel Hastings, director of process sciences at FUJIFILM Diosynth ...