Course Overview:

Auditing is a fundamental pillar of an effective Quality Management System (QMS). Whether performed to meet PIC/S GMP self-inspection requirements, ISO 13485 internal audit obligations, or supplier audit expectations, a well-designed audit program plays a critical role in sustaining compliance and ensuring the reliability of operations. Robust audits do far more than identify gaps—they strengthen organisational accountability, promote transparency, reinforce good practices, and help prevent issues before they escalate. When executed effectively, audits also serve as a powerful learning tool, enabling teams to understand processes more deeply and contribute to a culture of continual improvement.

This course offers a comprehensive, practical framework for planning, conducting, and evaluating both internal and external audits. Participants will learn how to align their audit processes with regulatory requirements, integrate risk-based decision-making, and gather objective evidence that withstands regulatory scrutiny. The training further emphasises how to document findings clearly, evaluate their impact, and connect them to meaningful and sustainable corrective and preventive actions (CAPA). By the end of the program, participants will understand how an effective audit cycle contributes to long-term compliance, operational excellence, and a proactive quality culture.

Course Outline:

Day 1 — Managing Internal & External Audits

Regulatory Overview

• The role of internal, external, and supplier audits in maintaining QMS effectiveness
• Writing clear, defensible audit findings and classification of observations
• Understanding regulatory frameworks: PIC/S GMP, ISO 13485, ICH Q10, and other relevant standards
• Integrating Quality Risk Management into audit planning and execution
• Techniques for gathering objective evidence: documentation review, interviews, walk-throughs, and observations
• Audit preparation: defining scope, understanding processes, and preparing checklists
• Essential documentation for strong audits: protocols, notes, reports, and records
• Developing risk-based audit schedules to prioritise high-impact areas
• Key auditing skills: communication techniques, questioning strategies, and professional behaviour

Day 2 — CAPA & Risk-Based Follow-Up

• Purpose, structure, and regulatory expectations for CAPA within a QMS
• Linking audit findings to effective corrective and preventive actions
• Using risk-based tools to assess the severity and impact of audit observations
• Ensuring CAPAs are SMART, evidence-based, and appropriately justified
• Techniques for root cause analysis and linking RCA outcomes to audit CAPAs
• Verification and effectiveness checks: ensuring CAPAs deliver the intended improvements
• Establishing a closed-loop audit process that feeds back into continuous improvement
• Best practices for documenting CAPA activities, timelines, and follow-up
• Preparing for regulatory inspection queries related to audit and CAPA processes

Participants

This program is ideal for operators, supervisors, managers, and professionals involved in quality systems, self-inspections, supplier audits, or regulatory compliance. It provides valuable skills for those responsible for planning audits, conducting assessments, documenting findings, or managing CAPA activities. Participants will leave with the knowledge and confidence needed to build and sustain an effective audit framework that enhances compliance, strengthens oversight, and drives continuous improvement across the organisation.