Seminar on Prepare and Submit 510(k) Premarket Notification Submissions for Success at Minneapolis

(prHWY.com) August 21, 2012 - Minneapolis, MN -- Summary:
GlobalCompliancePanel, a leading regulatory and compliance training gateway, will host a two-day, in-person seminar on the topic, "Prepare and Submit 510(k) Premarket Notification Submissions for Success" on September 6 and 7 in Minneapolis, Minnesota. The speaker of this RAPS-approved seminar, which can earn participants up to 12 RAC points, will be David Dills, an independent Regulatory & Compliance Consultant.
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Course Agenda:
Most medical devices manufactured and sold in the US required a 510 (K) submission. This is done to ensure that this new medical device is at least as safe as one in its class already in the market, or what is called a predicate device. This submission is required for most classes of medical devices.
This seminar will address the three types of Premarket Notification 510(k) s that may be submitted to FDA: Traditional, Special, and Abbreviated. Under the QS regulation, all Class II and III devices and certain Class I devices are required to be designed in conformance to 21 CFR 820.30 Design Controls. FDA provides guidance and this seminar will address key reminders when making critical decisions and to ensure submission and application success.
More than anything else, this seminar is designed to provide direction, guidance and clarity on preparing for, executing and submitting a 510(k) application. It will specifically take participants' questions, help address their pain points and challenges, and seeks to provide workable solutions. The expert will also propose suggestions for remediation with a participant's application prior to submission time and in anticipation of FDA questions and inquiries.
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Course Objectives:
o Know the differences between the Traditional, Special and Abbreviated submissions
o Understand Substantial Equivalence and how it is applied
o Who is required to submit the application to FDA
o Where to submit the 510(k) and what to expect with the review and approval process
o When it is not required to submit the 510(k)
o Exemptions to the submission process and special considerations
o How to locate a "predicate" device and go through the content and format of the 510(k)
o Understand the De Novo process and the expectations for possibly marketing a low risk device
o Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention
o Review and discuss 510(k) applications for group discussion and interactive participation
o Q&A and FAQ's
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About the Speaker:
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.

David has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.
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DATE AND VENUE:
September 6 and 7, 2012
Seminar Timings: 8am to 5pm EDT
Place: Minneapolis, Minnesota
Venue: Courtyard Minneapolis-St. Paul Airport
1352 Northland Drive Mendota Heights, Minnesota 55120 USA

Price -$ 1295 for bookings done up to August 17; $1495 for bookings done from August 18 to September 5; Register for 4 Participants to Get 1 Free Pass. Discounts offered for multiple registrations. Please contact Customer Care at 1800 447 9407
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Contact Information:

Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com/
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