This course introduces change control management . It will cover regulatory guidelines for change reporting.

Subject area:
cGMP

Objectives (If applicable):
•Explain regulatory requirements of change control
•Describe changes to manufacturing, facilities, utilities, equipment, test methods and specifications
•Recognize the critical aspects of regulatory reporting
•Summarize lifecycle management of changes including pre and post marketing changes
•Identify the elements of effective change control management
•Describe regulatory consequences of in efficient change control management through 483s/ WL

Target Audience (If applicable):
QA/QC Engineering
QA/QC Production
QA/QC Analytical
RA / transitioned into QA role from other functions