Curriculum
Course Description:
This two hour course provides a brief overview of the CAPA life cycle, roles and responsibilities, implementation, verification, effectiveness check. Regulatory consequences of incomplete CAPA management (483s, WLs) will also be addressed.
Upon completion of this course, you will be able to:
- Describe challenges associated with CAPA implementation and effectiveness.
- Identify and explain regulatory consequences of incomplete CAPA management (483s, WLs)
Who Should Participate:New recruits in he industry with at least 1 year of experience including:
- Analytical scientist
- QA/QC manager
- QA/QC staff
- QC chemist
- Regulatory
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