Internal audits deliver value irrespective of how mature your organization’s quality system is. Do you need help optimizing and delivering more value from your self-inspection / internal audit program? This course can help you achieve your KPIs.

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Content

  • GxP and Quality Auditing
    • Critical role of quality audit in GMP compliance & improvement
    • Regulatory standards and guidelines for quality auditing
    • GxP requirements for internal audit programs
    • Risk assessment as it applies to quality audit practices
    • Documents, records & data for effective audits
    • GxP audit schedules and the use of risk management in relation to prioritizing audits
    • Six fundamental steps of auditing explained in detail (including tips on how to manage & facilitate audits in a constructive manner)
  • Corrective and Preventive Action (CAPA) and Auditing
    • Defining Corrective and Preventive Action (CAPA)
    • Overview and systematic application of the CAPA system as it applies to quality audits
    • Relationship between CAPA and risk assessment / management
    • Risk assessment / management as it applies to audit scheduled and observations
    • Application of CAPA to audit observation deficiencies

Participants

This course is designed for operational personnel (key operators, supervisors and managers) who have a key role in quality systems implementation and will assist them to develop a system of quality audit.

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, May 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