Curriculum
- 6 Sections
- 25 Lessons
- 1 Day
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- Audit Fundamentals & Regulatory Context5
- 1.1Audit lifecycle, ISO 13485, ISO 9001, GMP, GCP, GLP, ICH Q10, 21 CFR Part 820
- 1.2Audit trail, Objective evidence, Critical vs major vs minor findings, CAPA linkage
- 1.3Differences between internal, external, and supplier audits
- 1.4Example: FDA warning letter linked to audit gaps in supplier oversight
- 1.5Exercise: Identify audit gaps in a mock quality management system
- Internal Audits – Driving Continuous Improvement4
- 2.1Risk-based internal audit planning, audit checklists, cross-functional participation, documentation practices
- 2.2Audit scope creep, Closing the loop, Risk prioritization
- 2.3Example: Internal audit uncovering systemic data integrity lapses
- 2.4Draft an internal audit plan for a medical device manufacturer
- Supplier Audits – Ensuring Quality & Compliance5
- 3.1Supplier qualification, monitoring, audits vs assessments, risk segmentation
- 3.2Approved supplier list (ASL), Supplier scorecards, Critical material suppliers
- 3.3Remote vs on-site supplier audits; managing offshore/third-party suppliers
- 3.4Example: Product recall traced to a non-compliant raw material supplier
- 3.5Exercise: Conduct a mock supplier audit interview (role play – auditor vs supplier)
- Handling Audit Findings & Driving CAPA4
- 4.1Categorizing findings, root cause analysis, CAPA effectiveness checks, escalation pathways
- 4.2Systemic vs isolated nonconformance, Effectiveness verification, Audit closure
- 4.3Example: Failed CAPA leading to repeat findings in a regulatory inspection
- 4.4Exercise: Sample audit observation and recommend corrective/preventive action
- Audit Readiness & Future Trends5
- 5.1Audit culture, remote audits, supplier partnerships, digital QMS tools
- 5.2Audit readiness mindset for-cause audit continuous verification
- 5.3How regulators view supplier oversight in global supply chains
- 5.4Transition from paper-based audits to digital platforms
- 5.5How would you ensure supplier audit readiness in a hybrid global environment?
- End-to-End Audit Case Study2