This program will address the 21CFR and Eudralex Volume 4 requirements and interpretation, as well as FDA Guidance regarding the creation, review and approval, and control of Master Production Records.
The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is meant by "list of components", the session will cover attachments and documentation expectations
The material will enable attendees to establish a consistent approach to the design of MPR, including cover page content, instructions, processing requirements and limits, and signature expectations. (There will also be a note on Device Master Record.) In addition to learning what is meant by "list of components", the session will cover attachments and documentation expectations
