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.
- 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
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.
Singapore, May 2020.
Dates can be flexible and we encourage you to contact us with your needs so we can discuss how to help.