CAPA - Root cause and risk management

Participants will learn how to write CA reports that will be used as written & how a well maintained CAPA system will save the company time and money. This course summarizes the cGMP requirements for Corrective Action Preventive Action (CAPA) and prepares participants to complete CAPA investigations on their own.

Participants will learn what it means to have control over deviations so that failures can be prevented before they happen. They will learn how to write CA reports that will be used as written. Participants will learn how a well maintained CAPA system will save the company time and money.

Areas Covered in the seminar:

• The Regulatory Requirements and draft guidelines.
• Root Cause Analysis techniques plus.
• Investigation- asking the right questions.
• Assignable cause -testing & verification.
• The difference between fixing the symptom and correcting the root cause.
• Contributing causes.
• The importance of an open, honest, and self correcting culture.
• What constitutes verification/validation of effectiveness?

Who Will Benefit:

• Supervisors
• Managers & technicians in Production
• Engineering
• Quality Control & Assurance
• Any personnel who perform investigations
• Write or revise deviations