| Description |
Strategy for Systematic Internal Audit Planning, Execution and Reporting
Bonus Material - Participants will receive
- an audit checklist with sample questions for the six quality systems
- an audit program score card to help you assess your own internal audit Program
A Two Day Comprehensive Course, with Interactive Discussions and Workshops On:
- Meeting FDA, EU, and ISO regulatory expectations
- Requirements for Medical Devices, Pharmaceuticals and Biotech Products
- Audit Mechanics
- Implementing a global management strategy
- Applying Six Sigma to Audit Program Improvement
- Types of audits and why they are necessary
- Auditor skills, qualifications, and communication skills
- How to prepare your team for an audit
- Implementing Unscheduled and “for cause” audits
- Implementing effective internal audits - Product, process and system audits
- Documentation requirements: Forms, Check-lists, Reports, etc.
- Strategic performance of an audit
- Distinguishing Minor and Major Observations – Audit rating
- Reporting findings to management
- Decision making based on audit findings
- Audit follow-ups and CAPA programs
- How to close-out audits
Interactive Workshop Activities
- Developing an effective Quality System Audit Program
- Benchmarking Audit Practices
- Laboratory Internal Audits
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