Writing Controlled Documents

Current Good Manufacturing Practices (cGMPs) in a regulated industry require the use of controlled documents. Participants in this course will learn strategies for designing and writing controlled documents, with the goal of minimizing risks for misinterpretation, and errors in communication. Participants will also gain an understanding of the associated regulatory requirements and will learn fundamental concepts of document control. Examples of documents discussed include Standard Operating procedures, Work Instructions, Batch and Test Records, Forms, and key documents central to many types of processes. Requirements of 21 CFR 11, Electronic Records; Electronic Signatures, will also be addressed.