This program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices. This webinar is especially helpful for new startup companies that are entering the medical device field for the first time.
Why Should You Attend:
In the United States, the US Food and Drug Administrates Medical Devices through several different regulations, the principle one is the Quality System Regulation 21 CFR 820 (QSR). Other regulations include Registration and Listing, Labeling, Medical Device Reporting, and Corrections and Removals (Recalls). This program will introduce the Quality System Regulation which defines the responsibilities for those who design, manufacture and distribute medical devices.Areas Covered in the seminar:
- This session will identify who is responsible under the Quality System Regulation.
- Identify the responsibilities of Suppliers to Medical Device Manufacturers.
- Limits of the Design Control Regulation.
- What is Validation? Includes Process, Design and Software Validation.
- Preparing for Inspection.
Who Will Benefit:
- This webinar is especially helpful for new startup companies that are entering the medical device field for the first time. It is also helpful for individuals that have not worked in the medical device field previously.
- Personnel new to the field should take both Part 1 and Part 2 sessions.
- Persons responsible for developing medical devices.
- Persons responsible for manufacturing medical devices.
- Persons responsible for purchasing components and services for medical device manufacturers.
- Persons responsible for quality systems, quality assurance and quality control.
- Persons responsible for servicing medical devices and for complaints.
Course Provider
Edwin L Bills,
