Curriculum
Course Description:
This course introduces change control management . It will cover
regulatory guidelines for change reporting.
Upon completion of this course, you will be able to:
- 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
Who Should Participate:New recruits in he industry with at least 1 year of experience including:
- QA/QC Engineering
- QA/QC Production
- QA/QC Analytical
- RA / transitioned into QA role from other functions
USP Approved Instructor Mr. T Lakshmana Murthy: Director, Quality assurance at USP-India and chief course designer of the QA course. He has over 21 years of experience in GMP auditing, Quality assurance and regulatory Compliance in the pharmaceutical industry