This course aims to help identifying regulatory requirements and expectations related to failure investigation, root cause analysis (RCA), and CAPA. The CAPA system not only to satisfy regulatory requirements but also to implement a closed-loop problem-solving system to help minimize quality issues and improve compliance.

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Content

  • Key steps and activities for an 8D problem analysis
  • General principles and approach for 8D problem analysis
  • General principles and approach for the use of FMEA in problem analysis
  • general principles and approach for the use of Fish Bone Diagram in problem analysis
  • Key steps and activities of risk management in problem analysis
  • CAPA elements and principles
  • Develop a CAPA form for observations / deficiencies
  • DMAIC approach of problem solving
  • Understand the SMART principles of CAPA
  • Link the concept of risk with CAPA management

Participants

Managers and supervisors responsible for GMP compliance, root cause analysis, failure investigations, and CAPA strategies will benefit from this program.

Format and Course Length

The 2-day course involves a lively mix of case studies / workshops and tutorial sessions. The delivery method is collaborative involving a small group and facilitator, which has been shown to enhance effective learning and critical thinking skills of participants. You will receive PDF copies of the training material and a Certificate of Attendance.

Possible Date

Singapore, September 2020.

Dates can be flexible and we encourage you to contact us with your needs so we can discuss how to help.

Refer to the Terms and Conditions