Hardly can one say they have been educated on pharmaceutical manufacturing without having come across the saying “if it wasn’t documented, it never happened”. This emphasizes the importance of documentation in the manufacturing process. This is what this course is about. Participants will learn about how the information documented is managed based on relevance and age (archiving and retention). You will also learn about how such information can be leveraged for future changes to the production process.
In this course, we provide a synthesis of the topic through an interactive online experience. This material was built by a team of Regulatory Affairs Experts with a Qualification from Northeastern University, Boston, piloted by a Senior Member able to articulate theory with practice
Lesson 1: What Are Good Data and Record Management Practices?
Lesson 2: Implementation of Good Data and Record Management Practices in GXP
Lesson 3: Life Cycle of a Record
Lesson 4: Organization of Records System in A GXP Set-up
Lesson 5: Master Document of a GXP Set-up: Site Master File
Lesson 6: List of Common Documents Maintained in GXP Set-up
Lesson 7: Records, Archiving, and Retention Using GDRP Principles in a GXP Set-up