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Event Manager
Compliance4All
161 Mission Falls Lane, Suite 216
Fremont, CA 94539
(800) 447-9407

Event Description

Overview:
The majority of medical devices are cleared for marketing in the U.S. by the FDA under the 510(k) process. The FDA holds companies responsible for filing new 510(k)s when one change is major enough to impact safety / effectiveness, or when a series of lesser changes finally reach the "tipping point".

Areas Covered in the Session:
    U.S. FDA device clearance / approval
    FDA's and EU's emphasis
    Product changes and filing a new 510(k) - who's responsible
    Tracking and evaluating changes - the "tipping point"

Who Will Benefit:
    Senior management, project leaders, internal / external consultants
    Regulatory affairs
    Quality systems personnel / QAE
    R&D and engineering staff

Speaker Profile:
John E Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.

Contact Detail:

Compliance4All DBA NetZealous,
Phone: +1-800-447-9407
Email: support@compliance4All.com
http://www.compliance4all.com/
Event Link : http://www.compliance4all.com/control/w_product/~product_id=501053LIVE?channel=mailer&camp=Webinar&AdGroup=eventsinamerica_Jan_2017_SEO
Twitter Follow us – https://twitter.com/compliance4all    
Facebook Like us – https://www.facebook.com/Compliance4all
LinkedIn Like us – https://www.linkedin.com/company/compliance4all

If the Webinar on Device Changes, FDA Changes, and the 510(k) is important to your business, act now and make the appropriate connections. See the contact information below.

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Event Details

Website: http://www.compliance4all.com/...
Conference/Event Dates: 01/25/2017 - 01/25/2017
Conference/Event Hours: 60 Minutes
Classification: B2B
Primary Industry: Medical
Other Industries: Manufacturing, Medical
Cost to Attend: One Dial-in One Attendee Price: $150.00
Audience: Senior management, project leaders, internal / external consultants
Regulatory affairs
Quality systems personnel / QAE
R&D and engineering staff

Booth Details

Booth Size Booth Cost   Available Amenities
No Exhibiting   Electricity: n/a
  Water: n/a
  Generator: n/a
  Marketing Vehicles Allowed: n/a
Other Booth Sizes Available: n/a

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