This course will outline the CAPA system; the tools used to identify the root cause of deviations, methods used for root cause analysis, and the processes for Corrective Action and remedial corrections of an identified problem. In addition to the lecture component, participants will review scenarios requiring CAPA, and learn strategies for implementing the CAPA process with the goal of averting recurrence of similar potential problems before they occur, and ensuring they do not happen again.
Participants in this course will understand the importance of creating and maintaining a Corrective Action Preventive Action system, to include:
• FDA Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations
• cGMP regulatory concepts that focus on investigating, understanding, and correcting discrepancies while attempting to prevent their recurrence
• Quality system models and CAPA as separate concepts, all of which are used in this guidance
• Remedial corrections of an identified problem (key word: correction), and root cause analysis
• Determining the cause of the deviation and potentially preventing recurrence of a similar problem (key words: corrective action)
• Preventive action to avert recurrence of a similar potential problem (key words: preventive action)
This course is available online, and can be taken anytime, anywhere.