Program Overview
This program led by a global industry expert with over 25 years of experience, equips participants with the knowledge and tools to conduct effective internal and supplier audits in the MedTech and Pharma sectors. Covering ISO 13485, GMP, GCP, ICH Q10, and FDA expectations, the program blends conceptual foundations with situational awareness, real-world case studies, and hands-on simulations. Participants will learn how to plan, conduct, and report audits, manage supplier quality risks, and translate findings into meaningful corrective and preventive actions (CAPA). The course emphasizes audit readiness, practical problem-solving, and building an audit culture that drives continuous improvement.
Features
- Understand internal and supplier audit requirements aligned with ISO, GMP, and FDA expectations
- Gain situational awareness of common audit challenges and regulatory nuances in MedTech and Pharma
- Learn from real-world case studies of audit successes, failures, and CAPA management
- Apply structured frameworks and simulations to plan, execute, and follow up on audits effectively
Target audiences
- Quality & Compliance Teams
- Regulatory Affairs Professionals
- Supplier Quality & Development Professionals
- Procurement Teams
- Internal Audit Teams
- Operational Excellence Leaders
Curriculum
- 6 Sections
- 25 Lessons
- 1 Day
Expand all sectionsCollapse all sections
- 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
Instructor
