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Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process

Date & Time: Thursday, November 17, 2011

10:00 AM PST | 01:00 PM EST

Duration: 3 Hours

Instructor: David R. Dills

Location: Online

Price : $395.00

 

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(for one participant)

Instructor Profile:

Detailed Agenda: l

David R. Dills Industry Regulatory & Compliance Consultant

Introduction and Regulatory Background ¡

There is no 510(k) form; however, 21 CFR 807 Subpart E

describes requirements for a 510(k) submission. Current trends with the 510(k) process. The Process ¡

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Who is Required to Submit a 510(k) When a 510(k) is Not Required When a 510(k) is Required Locating and justifying the Predicate Substantial Equivalence and demonstration of SE to another legally U.S. marketed device How to Prepare Submissions 510(k) Submission Methods List of forms associated with Premarket Notification 510(k) submissions Deciding When to Submit a 510(k) for a Change to an Existing Device What happens if FDA requires additional information and data and your responsibilities

Interactive Q&A, Wrap-Up and Adjourn ¡ ¡

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Q&A with all attendees Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry Discussion Points: some of the recommendations have included, but not limited to, redefining fundamental terms, limiting use of predicates, greater authority to rescind 510(k)s, etc. 510(k) Frequently Asked Questions Attendees should be prepared to address any issues and challenges as experienced on behalf of their company in this

David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has 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. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers. ...more

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Click here to register for this webinar 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.   It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

About GlobalCompliancePanel GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online compliance training by creating a single window of learning opportunities for compliance professionals & providing a forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,


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Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process  

Introduction and Regulatory Background ¡ There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submissi...

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