The US FDA Center for Biologics Evaluation and Research (CBER) finalized the December 2017 draft guidance titled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research” today. The guidance makes clear that CBER recognizes the value and proper usage of standards and further encourages the...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.