Micro Labs LimitedProduct: pharmaceutical manufacturing facility Date: 1/9/2015 1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). a) During the inspection, your management admitted that employees in both of your Quality Control (QC) laboratories had frequently...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.