Having trouble viewing this Message? View it Online
Live Webinar Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process Date: Tue, March 10, 2015 Instructor:David Dills
Time: 10:00 AM PST | 01:00 PM EST Location: Online
Duration: 3 Hours
Register Now
Overview: There are three types of Premarket Notification 510(k)s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
Objectives: Know the differences between the Traditional, Special and Abbreviated submissions Understand Substantial Equivalence and how it is applied Who is required to submit the application to FDA Where to submit the 510(k) and what to expect with the review and approval process When it is and is not required if you are a device company Exemptions to the submission process and special considerations How to locate a "predicate" device and go through the content and format of the 510(k) Understand the De Novo process and the expectations for possibly marketing a low risk device Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention
Who Will Benefit: This course is appropriate to those involved in all aspects of the premarket notification, i.e., 510(k) process on behalf of medical device and In Vitro Diagnostic manufacturers. It is both a primer for personnel new to the FDA 510(k) process, or an excellent refresher course for those who need to revisit the basics and fundamentals for a better understanding on how to prepare and submit your application to ensure regulatory and compliance success. Those who will benefit include professionals in R&D, development, quality assurance and quality control, production, operations, engineering, compliance, and regulatory affairs and all levels of management, including technical and laboratory personnel who desire to understand what it takes to prepare and submit a bulletproof 510(k) to FDA while at the same time are aware of the changing regulatory landscape regarding FDA's proposed changes to the 510 (k) process.
About Speaker David Dills Regulatory Affairs and Compliance Consultant, David Dills Regulatory Affairs & Compliance Consultant currently provides regulatory, compliance and quality consultative services for medical device and pharmaceutical/combination manufacturers, and also has an accomplished record with more than 24 years of experience with Class I/II/III medical devices, In Vitro diagnostics, and pharmaceuticals in the areas of Regulatory Affairs, Compliance and Quality Systems. He has been previously employed, with increasing responsibilities by medical device manufacturers and consultancies, including a globally recognized CRO. Since 2000, has provided consultative services on behalf of manufacturers and subcontracted by third-party consultancies and provides services involving all phases of the product development, submission, and commercialization process; Agency inspection readiness preparation and remediation; preparing Agency responses due to enforcement actions; conducting audits and assessments and preparing CAP/remediation plan; compliance engineering support, regulatory planning; post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP
Click here to register for this webinar
...more
Suggest a Topic
More Webinars
Compliance4All www.compliance4all.com
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: 800-447-9407 or Fax your PO to: 302-288-6884 If you do not wish to receive this training alerts from Compliance4All Click Unsubscribe