Get documents about "2-day In-person Seminar on Prepare and Submit 510(k) Premarket Notification Submissions for Success at Minneapolis
Description
The majority of medical devices commercialized in the United States require a 510(k) submission, which is used to demonstrate that the medical device is at least as safe and effective, or substantially equivalent, to a predicate device, meaning a device that is legally marketed and is not subject to a PMA. Many companies planning to introduce a medical device to the US market need to submit an application to the FDA called a 510(k).
Document Sample
View this email in your browser | Unsubscribe from future mailings
2-day In-person Seminar on
Prepare and Submit 510(k) Premarket Notification Submissions for
Success
Course "Prepare and Submit 510(k) Premarket Notification
Submissions for Success" has been pre-approved by RAPS as
Register Now
eligible for up to 12 credits towards a participant's RAC
recertification upon full completion.
Date & Time: Instructor Profile:
September 06th and 07th
8 AM to 5 PM EDT
2012 David R. Dills
Industry Regulatory &
Duration: 2 Days Instructor: David R. Dills Compliance Consultant,
Location: Minneapolis,
Price : $1295.00 (for one participant) David R. Dills, an independent
Minnesota
Regulatory & Compliance Consultant
Register for 4 Participants to Get 1 Free Pass with more than 22 years of hands-on
experience and a proven track
record within the FDA regulated
industry, has an extensive
Overview:
regulatory and compliance
The majority of medical devices commercialized in the United States background with Class I/II/III and
require a 510(k) submission, which is used to demonstrate that the IVD devices and managing and
medical device is at least as safe and effective, or substantially handling activities within the global
equivalent, to a predicate device, meaning a device that is legally regulatory and compliance
marketed and is not subject to a PMA. Many companies planning to landscape. He manages quality,
regulatory and compliance projects
introduce a medical device to the US market need to submit an
with multiple competing priorities
application to the FDA called a 510(k). The 510(k) is needed for some
having a direct impact on site
Class I devices, not all since some are exempt, and nearly all Class II operations and commercial
devices and a very small number of Class III devices. This seminar opportunities and develops
will outline all of the critical and key steps involved and provide a strategies for governmental approval
detailed overview of how the FDA 510(k) process works. to introduce new products to market,
provides guidance and direction on
The Center for Devices and Radiological Health (CDRH) within the FDA regulatory and compliance
requirements and prepares/reviews
receives more than 4,000 (approximately) 510(k) submissions
worldwide
annually. Within CDRH, the Office of Device Evaluation (ODE) and the
submissions/dossiers/technical files
Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) are and addresses requirements in the
responsible for processing and reviewing 510(k)’s. Branches within EU, Pacific Rim and The Americas
these offices are organized according to medical scientific disciplines regarding all aspects of device
and are staffed by FDA reviewers. These reviewers, who are commercialization and especially
biomedical engineers, physicians, microbiologists, chemists, and FDA activities. Background
other professionals, will determine whether a new medical device is encompasses broad capabilities in
quality systems, validation,
substantially equivalent and can be marketed in the United States.
regulatory affairs, GxP compliance,
Typically, this FDA decision is made within 90 days.
auditing, interfacing with the
regulatory agencies, managing
Course Outline: enforcement actions and mitigating
compliance exposure for companies,
working with Notified Bodies, AR’s
Course Outline: Day 1: and demonstrates credible
experience to maximize business
Lecture 1: performance in the devices arena.
He strives to optimize business
performance through proactive
l Introductions/Background
strategies to mitigate compliance
l Current trends with the 510(k) process
exposure by providing strategic and
l Marketing clearance from CDRH
tactical solutions that facilitate the
l Who is Required to Submit a 510(k) achievement of regulatory
l When a 510(k) is Not Required milestones. David has been
l Preamendment Devices previously affiliated with well-known
l Locating and justifying the Predicate device manufacturers and service
l Substantial Equivalence and demonstration of SE to another providers, including a well-known
CRO and has served in various
legally U.S. marketed device
quality, regulatory and compliance
l How to Prepare Submissions and Walk Through the Entire
management and advisory capacities
Process
with increasing responsibilities.
l 510(k) Submission Methods David is an accomplished industry
l List of forms associated with Premarket Notification 510(k) speaker and author of technical and
submissions compliance related topics published
l Deciding When to Submit a 510(k) for a Change to an Existing in industry journals. Please refer to
Device - is a new 510(k) required for a modification to your his profile provided herein for
additional information about his
device?
background. ...more
l What happens if FDA requires additional information and data
and your responsibilities
l Performing a 510(k) assessment to identify or confirm the most
appropriate predicate device(s) and ensuring that you have Suggest a Topic More Webinars
addressed potential FDA triggers and red-flags
Your Necessity is our Priority
l Developing and preparing a written argument for “substantial
equivalence” that will compare your device to a predicate
device(s).
l Identifying any applicable FDA Guidance Documents
l Debrief
Course Outline: Day 2:
Lecture 2:
l Third-Party Review Program
l Communicating directly with FDA staff to identify any special
requirements that may impact the review of your 510(k), if
necessary
l Preparing and submitting the 510(k) document to the FDA
l FDA requests for more information, clarification and requests
for more data: how to handle strategically
l Coordinating any communications and negotiations with the
FDA reviewer, and preparing responses to FDA questions, if
necessary
l Log-In Procedure to check on status
l Reviewer Assignment
l Review Fees
l Decision Letter Issued
l Group discussion and review of recent 510(k) clearances and
proposals and recommendations between FDA and industry
l Discussion Points and FDA Trends
l Execute an effective path to approval for future submissions
l Analyze the benefits/risks for informed decision-making and
interpreting the regulatory precedents and new legislation
with the 510(k) process
l 510(k) Frequently Asked Questions, Q&A, Wrap-Up and
Adjourn
l Attendees and participants should be prepared to address any
issues and challenges as experienced on behalf of their
company in this open-forum and interactive session
Click here to register for this seminar
Who Will Benefit:
l Professionals in R&D
l Quality Assurance and quality control
l Production
l Operations
l Engineering
l Compliance
l Regulatory Affairs and all Levels of Management
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,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.
GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801
Phone: 800-447-9407 or
Fax your PO to: 302-288-6884
If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe
Related docs
Other docs by globalcompliancepane
Maintaining a Validated State - PV, PM and Statistics associated with Current Regulations
Views: 8 | Downloads: 0
2-day In-person Seminar on " Mastering the HIPAA Privacy, Security, and Breach Notification Rules: Coping with Rule Changes, Managing Incidents, Preparing for Audits, and Avoiding"
Views: 157 | Downloads: 0
FDA 510(k): Preparation, Submission, and Clearance - Webinar By GlobalCompliancePanel
Views: 9 | Downloads: 0
