Why is design control so important?
Both the FDA QSR and ISO 9001 require that design controls be implemented to ensure products are safe and effective for their intended use. The ability of an organization to implement an effective design control system is critical for both compliance with regulatory requirements and to meet customers expectations. This course is designed to provide participants with the knowledge and skills necessary to implement an effective design control program which meets ISO 9001 and FDA QSR requirements. Interactive exercises help participants understand first hand how to apply design control concepts/requirements.
This Course is for you if:
- You manufacture Class III, Class II and select Class I medical devices.
- You are responsible for leading or participating on a project team subject to FDA or ISO design control requirements.
- You manage the development process or participate in quality system audits.
You’ll be provided with:
- An in-depth review of design control requirements
- "Real life" interactive implementation examples
- FDA’s Inspection Technique
- Typical auditor questions related to design control requirements
Introduction to Design Controls
General Requirements and Applicability
Benefits of Design Control
FDA Inspection Technique
Typical Areas of Non-Compliance
Design & Development Planning
Design History File