Live Web Seminar – An Exclusive Look at the Best Practices in 510(k) Submissions
“An Exclusive Look at the Best Practices in 510(k) Submissions”
Speaker: Bill McLain, RAC; Keystone Regulatory Services, LLC
Live Web Seminar
Thursday, May 3, 2007 9:00-11:30 a.m. EST
Visit: http://www.benastrum.com/2.html
Prior to releasing new products to the market, medical device companies must obtain approval from the Food and Drug Administration. This approval process consists of filing a Pre-market Notification with the FDA, also known as an FDA 510k application, at which point the submission will be reviewed by the appropriate agencies to determine whether the new device is substantially equivalent (SE) or not substantially equivalent (NSE). This process can be complicated, especially for companies that are not familiar with the details or concepts related to 510(k) submissions.
For companies with limited RA/QA resources, as well as industry professionals interested in learning about the FDA 510k application, this web seminar will introduce the basic concepts and best practices of the 510(k) submission process, as well as review methods for finding predicates, using guidance documents and interacting with the agency. Participants will have the opportunity to learn about the different types of 510(k) submissions and the benefits and drawbacks of using the 3rd party review process. Other communication tools will also be discussed, including the request for information (513g) and preIDE meeting.
Topic:
“An Exclusive Look at the Best Practices in 510(k) Submissions”
- What is a 510(k)
- What does it cost?
- Types of 510(k) submissions (including 3rd party review)
- Content of 510(k)’s
- Tips on picking predicates
- When clinical data willbe requiredThe right time in your development cycle to submit a 510(k)
- My 510(k) is submitted – now what?
- How to establish contact with the agency
- What to do if things go horribly wrong
Speaker Bio: Bill McLain, RAC
Bill McLain is the President and Principal Consultant of Keystone Regulatory Services, LLC, a regulatory affairs and quality systems consulting firm for the medical device industry. Having held several positions of increasing responsibility exclusively with device manufacturers, Mr. McLain brings 15 years of experience, ranging from manufacturing and product development engineering to regulatory affairs and quality system management. Mr. McLain brings a comprehensive, yet practical approach to regulatory and quality systems, and understands the challenges of getting a device to market and creating a quality system that does not overburden manufacturing operations.
Registration Office:
Michael Riva
Event Coordinator
Local: (514) 337-1616 x221
Fax: (514) 337-8803
Email: Michael.Riva@BenAstrum.com
Session Fee (Per web seminar):
Registration Fee for One Attendee (Before Early Bird Deadline): 299 USD
Registration Fee for One Attendee (After Early Bird Deadline): 345 USD
Registration Fee per Additional Attendee (using same login settings): 149 USD
Early Bird Deadline: Friday, April 20, 2007 @ 8 p.m. EST
Registration Deadline: Tuesday, May 1, 2007 @ 8 p.m. EST
Corporate Attendance Fee (using same login settings):
- Maximum of 12 Attendees: 1,500 USD
- Maximum of 20 Attendees: 2,000 USD
- Maximum of 50 Attendees: 5,000 USD
*All Taxes Included*
***BenAstrum will honor all webinar attendees with a Certificate of Attendance signed by the Chair of the specific event and BenAstrum’s President. Attendees will receive their BAPB certificate within 3-4 weeks of participating in the webinar. ***
***Please note that to ensure the utmost quality and effectiveness of our webinars, there is a maximum of 50 login settings per session ***
***All cancellations will result in transfer of registration credit for any future events within 6 months***
Sponsorship:
During each webinar, a 5-minute break period will be allotted for companies to promote new products and technologies in today’s fast paced environment. Click the link for more information on sponsoring an event.
Sponsorship Inquiries:
Mike Rozbih
VP of Business Development
Tel: (514) 887-8009
Email: mike.rozbih@benastrum.com
Benefits Include:
- Learn from prominent speakers during live sessions, within the comfort of your own office
- Gain breakthrough insights from senior pharmaceutical consultants
- Explore best practices from top companies
- Learn about the latest products and technologies in the pharmaceutical industry
- Interactive and hands-on workshops providing in-depth learning opportunities
- Enjoy extended online networking
- & much more
Visit: http://www.benastrum.com/2.html
