The main goals of this e-learning course are to give learners a grounding in the principles of and latest requirements for Electronic Records regarding FDA 21 CFFR PART 11. The training provides an overview of the FDA requirements with practical examples covering the implementation of those requirements. The course covers the application of these requirements to both hardware and software systems used in Manufacturing, QA, Regulatory, validation and the Control of Processes.
In this course, we provide a synthesis on 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.
Who should take this course
Module 1: The Predicate Rules
21 CFR Part 11 explained
What are the predicate rules?
Relationship to the predicate rules
Predicate rules and batch records
Module 2: What is Part 11
What is 21 CFR Part 11?
Narrow scope and application of Part 11
Module 3: E-Signatures and E-Records Explained
E-Signatures not impacted