Good Documentation Practices are critical within organizations implementing a controlled document system. With an emphasis on maintaining a system of control, participants will learn strategies, standards, and practices for accurately completing controlled documents in a cGMP work environment. In addition, participants will learn to implement ALCOA, an acronym for a method used to ensure information is properly collected, recorded, and stored. 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.
This course is powered and delivered by the CITI Program. To learn more about this course and to register, please visit the CITI Program website.