GxP and Quality Auditing Practices

Aims:     
To provide an introduction to auditing principles and practices , and to develop a broad understanding of the requirements and techniques for planning, conducting and reporting quality audits applicable to manufacturing systems for drugs, biologics and devices.

Outline Syllabus: 

• Critical role of quality audit in GMP compliance & improvement.
• GMP regulatory audits
• Standards and guidelines for quality auditing
• GMP requirements for internal audit programs
• Techniques for auditing.
• Documents, records & data for effective audits.
• The role of audits in supplier assurance and qualification.
• Utilisation of risk management in relation to prioritising audits and reporting of deficiencies.

Learning Outcomes:
On successful completion of this module, the student will be able to:

(1) Knowledge and Understanding

• State the attributes of a competent auditor
• Discuss the intent and principles of systems and compliance auditing
• Identify audit standards and guidelines.
• Discuss the role of audits and CAPA in continuous improvement

(2) Discipline skills

• Prepare audit plans and checklists
• Conduct quality audits of GMP systems, and manufacturing processes and controls
• Classify deficiencies according to relevant regulatory standards and guidelines
• Assess GMP risks
• Prepare audit reports
• Apply CAPA principles to audit follow-up activities