Advanced Quality and Compliance Auditing
Advanced Quality and Compliance Auditing
Course Dates
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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)
- Audit Planning and Execution
- Regulatory and Compliance Expertise
- Risk Management and Root Cause Analysis
- CAPA Management
- Audit Reporting and Documentation
- Stakeholder Engagement and Communication
- Continuous Improvement and Change Management
This training course will be carried out through the use of best practices and the right combination of engaging and purposeful tools such as:
- Practical, relevant case studies
- Group activities and workshops
- Related role plays
- Experiential learning
- Brain storming
- Stimulating mental activities
- Engaging team competitions
- Suitable training videos
- Presentations
- Self-assessments
- Learning with simulations and games
- Quality Assurance/Quality Control (QA/QC) Professionals
- Compliance and Regulatory Affairs Professionals
- Internal Auditors and Lead Auditors
- Managers and Senior Leaders
- Professionals Preparing for Certification