Course Description:
This four hour course provides an overview of deviations, regulatory guidelines, investigation roles and responsibilities as well as stages of investigation. Investigation plans, tools, root cause analysis (RCA) and an overview of CAPA will also be covered.
Upon completion of this course, you will be able to:
- Summarize the roles and responsibilities, effectiveness of implementation of CAPA and verification processes.
- Explain the regulatory repercussions of incomplete deviation investigations (483's, WL)
- Demonstrate knowledge of root cause analysis tools and their application for investigation of OOS and deviation through structured exercises and case studies.
Who Should Participate:New recruits in he industry with at least 1 year of experience including:
- Analytical scientist
- QA/QC analysts
- R&D scientists, manager
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract manufacturing organizations
USP Approved InstructorDr. Raghunandan: 25 Years of industry and academia experience. Areas of expertise are Quality assurance, Quality control, Regulatory affairs, Manufacturing Formulations/APIs/ Biologicals, Contract manufacturing, Technical consultation, Research and Education
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