Introduction to the FDA Quality Systems Regulations for Internal Auditors
An ineffective audit can mean severe consequences, resulting in process failure, customer dissatisfaction and regulatory non-compliance.
Optimize your auditing skills with a deeper insight of the FDA Quality Systems Regulations and learn what to look for in a quality management system (QMS) that is compliant with ISO 13485.
Who should attend?
- Quality Managers
- Internal Auditors
- Regulatory Affairs Managers
Note: Knowledge of the FDA Quality Systems Regulations are a prerequisite for this course.
What will I learn?
You will learn about:
- FDA Quality System Regulation (QSR) requirements
- What points to consider when auditing the requirements as part of an internal audit in conjunction with ISO 13485
- Training course notes