At the end of this course, the participants should be able to:
- Develop and execute comprehensive audit plans for quality and compliance systems.
- Effectively conduct audits, ensuring that evidence is properly gathered and documented.
- Report audit findings clearly and identify corrective actions for improvement.
- Apply advanced auditing techniques in highly regulated industries and environments.
- Demonstrate the ability to handle complex audit scenarios through case study analysis.
Unit 1: Introduction to Quality and Compliance Auditing
- Overview of Auditing
- Importance of auditing in quality management
- Role of auditors in compliance and continuous improvement
- Types of audits: internal, external, third-party, and regulatory
- Key Regulations & Standards
- Introduction to ISO 9001, ISO 13485, FDA, GxP, and other relevant regulations
- Key concepts in compliance: risk management, non-conformance, and corrective actions
- Audit Process Overview
- The audit lifecycle: Planning, execution, reporting, and follow-up
Unit 2: Audit Planning and Preparation
- Audit Planning and Scope Definition
- Setting objectives and scope for an audit
- Identifying audit criteria and resources
- Risk-based audit planning
- Audit Checklists and Documentation
- Designing effective audit checklists and tools
- Review of documentation: policies, procedures, and records
- Audit Team Selection
- Roles and responsibilities of audit team members
- Managing conflicts of interest and ensuring impartiality
Unit 3: Conducting the Audit
- Opening and Closing Meetings
- Best practices for opening and closing meetings
- Engaging stakeholders and ensuring transparency
- Auditing Techniques
- Effective data collection: Interviews, observations, document reviews
- Identifying non-conformances and evidence collection
- Managing Audit Evidence
- Ensuring objectivity and integrity in evidence gathering
- Techniques for documenting findings
Unit 4: Reporting Findings and Corrective Actions
- Audit Reporting
- Structuring audit reports: Executive summaries, findings, recommendations
- Categorizing non-conformances (major vs. minor)
- Writing clear and actionable audit reports
- Corrective Actions & CAPA
- Root cause analysis and corrective action plans (CAPA)
- Evaluating and verifying effectiveness of CAPA
- Compliance Verification
- Ensuring compliance through audit findings and post-audit activities
Unit 5: Advanced Auditing Techniques and Practical Application
- Advanced Auditing Concepts
- Auditing in regulated industries (pharmaceuticals, medical devices, etc.)
- Auditing for data integrity and digital systems (e.g., software validation)
- Understanding environmental and ethical compliance requirements (ESG)
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