This program will cover the remaining regulations excluding the QSR which was covered in Part 1.
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 cover the remaining regulations excluding the QSR which was covered in Part 1.
Areas Covered in the seminar:
- This session will cover the responsibilities of the manufacturer for the regulations not covered in Part 1, Registration and Listing, Labeling, Medical Device Reports and Corrections and Removals (Recalls).
- What are the additional responsibilities of the Medical Device Manufacturer?
- New rules for Registration and Listing-paying the fees.
- What is Labeling-what about websites and videos?
- Do I really have to report adverse events in multiple countries?
- What field actions require reporting to the FDA?
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 quality systems, quality assurance and quality control.
- Persons responsible for complaints.
Instructor Profile:
Edwin L. Bills, was a Quality and Regulatory Affairs Director at an international medical device manufacturer for 5 years after serving in a variety of positions with increasing responsibility in the medical device industry, including Supplier Quality Engineer and Manager, Quality Systems and Regulatory Affairs Manager, Product Risk Manager, and Director of North American Service Quality. He is Regulatory Affairs Certified by RAPS, and also a Certified Quality Engineer, Certified Quality Auditor, and Certified Manager of Quality/ Organizational Excellence by ASQ and is an ASQ Senior Member.
ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria..Credit available for Live webinar Attendees only.
