<table class="altawail-two-col" width="100%"> <tbody> <tr><!-- Column 1 --></p> <td width="47%"><strong>What will I benefit?</strong></p> <p>This course aims to equip you with a range of practical, in-depth benefits that can significantly enhance your auditing skills, improve your organization’s quality and compliance systems</p> <p><strong>Course Objectives:</strong></p> <p style="text-align: right"><strong>At the end of this course, the participants should be able to</strong></p> <ul> <li style="text-align: right">Develop and execute comprehensive audit plans for quality and compliance systems.</li> <li style="text-align: right">Effectively conduct audits, ensuring that evidence is properly gathered and documented.</li> <li style="text-align: right">Report audit findings clearly and identify corrective actions for improvement.</li> <li style="text-align: right">Apply advanced auditing techniques in highly regulated industries and environments.</li> <li style="text-align: right">Demonstrate the ability to handle complex audit scenarios through case study analysis.</li> </ul> <p><strong>Target Audience:</strong></p> <ul> <li style="text-align: right">Quality Assurance/Quality Control (QA/QC) Professionals</li> <li style="text-align: right">Compliance and Regulatory Affairs Professionals</li> <li style="text-align: right">Internal Auditors and Lead Auditors</li> <li style="text-align: right">Managers and Senior Leaders</li> <li style="text-align: right">Professionals Preparing for Certification</li> </ul> </td> <p><!-- GAP Column --></p> <td width="6%"></td> <p><!-- Column 2 --></p> <td width="47%"><strong>Target Competencies:</strong></p> <ul> <li style="text-align: right">Audit Planning and Execution</li> <li style="text-align: right">Regulatory and Compliance Expertise</li> <li style="text-align: right">Risk Management and Root Cause Analysis</li> <li style="text-align: right">CAPA Management</li> <li style="text-align: right">Audit Reporting and Documentation</li> <li style="text-align: right">Stakeholder Engagement and Communication</li> <li style="text-align: right">Continuous Improvement and Change Management</li> </ul> <p><strong>Course Methodology</strong><strong>:</strong></p> <p style="text-align: right"><strong>This training course will be carried out through the use of best practices and the right combination of engaging and purposeful tools such as:</strong></p> <ul> <li style="text-align: right">Relevant case studies and practical examples</li> <li style="text-align: right">Group activities and workshops</li> <li style="text-align: right">Related role plays</li> <li style="text-align: right">Experiential learning</li> <li style="text-align: right">Brainstorming</li> <li style="text-align: right">Stimulating mental activities</li> <li style="text-align: right">Engaging team competitions</li> <li style="text-align: right">Suitable training Videos</li> <li style="text-align: right">Presentations</li> <li style="text-align: right">Self–assessments</li> <li style="text-align: right">Learning with Simulations and Games</li> </ul> </td> </tr> </tbody> </table>

<table class="altawail-two-col" width="100%"> <tbody> <tr><!-- Column 1 --> <td width="47%"> <p style="text-align: right"><strong>Introduction to Quality and Compliance Auditing</strong></p> <ul style="text-align: right"> <li><strong>Overview of Auditing</strong> <ul> <li>Importance of auditing in quality management</li> <li>Role of auditors in compliance and continuous improvement</li> <li>Types of audits: internal, external, third-party, and regulatory</li> </ul> </li> <li><strong>Key Regulations & Standards</strong></li> <li style="list-style-type: none"> <ul> <li>Introduction to ISO 9001, ISO 13485, FDA, GxP, and other relevant regulations</li> <li>Key concepts in compliance: risk management, non-conformance, and corrective actions</li> </ul> </li> <li><strong>Audit Process Overview</strong></li> <li style="list-style-type: none"> <ul> <li>The audit lifecycle: Planning, execution, reporting, and follow-up</li> </ul> </li> </ul> <p style="text-align: right"><strong>Audit Planning and Preparation</strong></p> <ul style="text-align: right"> <li><strong>Audit Planning and Scope Definition</strong></li> <li style="list-style-type: none"> <ul> <li>Setting objectives and scope for an audit</li> <li>Identifying audit criteria and resources</li> <li>Risk-based audit planning</li> </ul> </li> <li><strong>Audit Checklists and Documentation</strong></li> <li style="list-style-type: none"> <ul> <li>Designing effective audit checklists and tools</li> <li>Review of documentation: policies, procedures, and records</li> </ul> </li> <li><strong>Audit Team Selection</strong></li> <li style="list-style-type: none"> <ul> <li>Roles and responsibilities of audit team members</li> <li>Managing conflicts of interest and ensuring impartiality</li> </ul> </li> </ul> <ul style="text-align: right"> <li style="list-style-type: none"></li> </ul> </td> <!-- GAP Column --> <td width="6%"></td> <!-- Column 2 --> <td width="47%"> <p style="text-align: right"><strong>Conducting the Audit</strong></p> <ul style="text-align: right"> <li><strong>Opening and Closing Meetings</strong></li> <li style="list-style-type: none"> <ul> <li>Best practices for opening and closing meetings</li> <li>Engaging stakeholders and ensuring transparency</li> </ul> </li> <li><strong>Auditing Techniques</strong></li> <li style="list-style-type: none"> <ul> <li>Effective data collection: Interviews, observations, document reviews</li> <li>Identifying non-conformances and evidence collection</li> </ul> </li> <li><strong>Managing Audit Evidence</strong></li> <li style="list-style-type: none"> <ul> <li>Ensuring objectivity and integrity in evidence gathering</li> <li>Techniques for documenting findings</li> </ul> </li> </ul> <p style="text-align: right"><strong>Reporting Findings and Corrective Actions</strong></p> <ul style="text-align: right"> <li><strong>Audit Reporting</strong></li> <li style="list-style-type: none"> <ul> <li>Structuring audit reports: Executive summaries, findings, recommendations</li> <li>Categorizing non-conformances (major vs. minor)</li> <li>Writing clear and actionable audit reports</li> </ul> </li> <li>Corrective Actions & CAPA</li> <li style="list-style-type: none"> <ul> <li>Root cause analysis and corrective action plans (CAPA)</li> <li>Evaluating and verifying effectiveness of CAPA</li> </ul> </li> <li><strong>Compliance Verification</strong></li> <li style="list-style-type: none"> <ul> <li>Ensuring compliance through audit findings and post-audit activities</li> </ul> </li> </ul> <p style="text-align: right"><strong>Advanced Auditing Techniques and Practical Application</strong></p> <ul> <li style="text-align: right"><strong>Advanced Auditing Concepts</strong></li> <li style="list-style-type: none"> <ul> <li style="text-align: right">Auditing in regulated industries (pharmaceuticals, medical devices, etc.)</li> <li style="text-align: right">Auditing for data integrity and digital systems (e.g., software validation)</li> <li style="text-align: right">Understanding environmental and ethical compliance requirements (ESG)</li> </ul> </li> </ul> </td> </tr> </tbody> </table>