10:00 AM - 02:00 PM
DAY 1

Lecture 1: Overview and Regulatory expectations

Lecture 2: Quality Systems requirements for medical devices

Lecture 3: The Audit Program
- Types and goals of audits
- Creating a program
- Goals
- Risk Analysis
- Audit schedule
- Oversight, communication, monitoring, and escalation

Lecture 4: Linkages in your Quality System
- CAPA
- Metrics and Monitoring
- Management Review
- What the FDA can look at
- Record keeping and documentation

Lecture 5: Auditor Qualifications and Skills

10:00 AM - 02:00 PM
DAY 2

Lecture 1: The Auditing Process
- Preparation
- Planning
- Conducting
- Interviewing techniques
- Good documentation
- Following-up
- Monitoring progress

Lecture 2: Focus on Supplier Auditing

Lecture 3: Red Flags and Warning Signs

Lecture 4: Best Practices

Interactive Discussion and Exercises