RAPS pre-approved webinar on "Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process" from GlobalCompliancePanel
"Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process" is the topic ofa RAPS pre-approved webinar that GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize on February 13.
- Fresno, CA (1888PressRelease) February 13, 2013 - Description:
This webinar is about the latest changes made to the 510 (K) process of the FDA, and how medical device companies can come up with a surefire method to make submissions that could ensure FDA approval while adhering to regulatory requirements.
A 510 (K) submission is a premarket submission made to the FDA with the purpose of demonstrating that a medical device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval.
This webinar will explain the nature of the three types of Premarket Notification 510(K)'s that may be submitted to FDA: Traditional, Special, and Abbreviated. It will describe the differences between these.It will also offer an explanation of the rationalefor which the Special and Abbreviated 510(K) methods were developed. As a result of these new types; product modifications that could significantly affect safety and effectiveness are subject to 510(K) submission requirements under 21 CFR 807 as well as design control requirements under the Quality System (QS) regulation.
Quality Systems regulations require that all Class II and III devices and certain Class I devices be designed in conformance to 21 CFR 820.30 Design Controls. The FDA provides guidance on these.
This course will address these points relating to these issues. As a result of this learning; key persons in the organization will find it easier to take critical decisions.
When:February 13, 10:00 AM PDT | 01:00 PM EDT
By whom:
David R. Dills, Independent Regulatory & Compliance Consultant, worked for PAREXEL Consulting till July 2008, when he had to leave due to a service line organizational shakeup. Prior to joining the consultancy, Mr. Dills provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in-vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems.
David currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He also serves on the Readers' Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and as Advisor for the ASQ's Section 1506. He is a former Chair and Co-Chair and an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.
David has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.
For whom:
The webinar will benefit
- R&D
- Quality Assurance
- Quality Control
- Production
- Operations
- Engineering
- Compliance and Regulatory Affairs
- All Levels of Management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k)
Duration: 90 minutes
To enroll for this webinar, contact
webinars ( @ ) globalcompliancepanel dot com
Phone: 800-447-9407
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