Part 11 and Computer Validation Manual and CD, The FDA Regulations on Part 11, Electronic Records and Electronic Signatures, For Pharmaceutical, ... With Emphasis on Computer System Validation a

This is a package of Agent GXP FDA Part 11 and Pharmaceutica Computer Validation Introduction. These two related courses will give the learner an excellent introduction to computer isues in the pharmaceutical industry. This course will teach you the history, applications, regulations, implementation, ideas and how to prepare Part 11.