Device Changes, FDA Changes, and the 510(k) Web Conference by Compliance4all

  • 150.00 Dollar US$
  • Published date: November 11, 2016
    • Online, California, United States

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=science-marketplace_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

Result 0 votes
Compliance4All
0 votes

Useful information

  • Avoid scams by acting locally or paying with PayPal
  • Never pay with Western Union, Moneygram or other anonymous payment services
  • Don't buy or sell outside of your country. Don't accept cashier cheques from outside your country
  • This site is never involved in any transaction, and does not handle payments, shipping, guarantee transactions, provide escrow services, or offer "buyer protection" or "seller certification"

Related listings

  • Power Pivot and Power Query 101 [BI tool] 2019

    Power Pivot and Power Query 101 [BI tool] 2019

    Other Services Fremont (California) November 13, 2018 150.00 Dollar US$

    Overview: Power Pivot puts the "power" into Pivot Tables (hence the name!), removing many of limitations and frustrations that many advanced users find with Pivot Tables. Why should you Attend: If you work with, analyse and generate reports from larg...

  • Tricks To Get The [Most Out] Of Your Device Master Records

    Tricks To Get The [Most Out] Of Your Device Master Records

    Other Services Fremont (California) November 13, 2018 Free

    Overview: It will also consider the European Union's MDD TF/DD requirements, and evaluate the documents' differing purposes / goals, as well as the two different device classification schemes. Required and desirable contents will be discussed. Why sh...

  • Compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR

    Compliant with 21 CFR Part 11, data integrity, SaaS/Cloud, and EU GDPR

    Other Services San Diego (California) October 25, 2018 1295.00 Dollar US$

    Description: • This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments. • It det...