home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
  HUM-MOLGEN -> Events -> Meetings and Conferences  
 

Medical Device Changes and The 510(k) - Webinar By GlobalCompliancePanel

 
  December 13, 2010  
     
 


GlobalCompliancePanel, Online Training Webinar
2011-02-23


Overview: This webinar will examine the broad range of issues to be considered by a company when reviewing

1) A series of minor changes or

2) One major change to an existing product having an existing 510(k), for the need for a new 510(k).

Such a review takes on added urgency as a result of the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and what it (the FDA and industry) need to do to "toughen" the 510(k) process. A review of recent information from the Agency, including last summer's Working Group findings on the 510(k), Vol. I, as well as other goals of the Agency that have already been translated into action in the past year will provide direction in areas of concern and what to expect in the future. This will be performed by a review of FDA-stated areas of required review and a suggested matrix format. Anticipation and addressing such on-going product modifications / changes proactively will further prove a company is "in control", and assist documenting the 510(k) submission (or 'not') rationale.

Why should you attend: The FDA expects companies to perform meaningful, results driven 510(k) / change analysis activities. The company is held fully responsible for deciding when a new 510(k) filing is warranted. Growing high-profile field problems indicate that change control and it’s effect on regulatory review activities are not yet fully utilizing the power of current risk management tools, which must be a part of such an analysis. A growing push by the Agency to strengthen the 510(k) process in the U.S. and take a renewed look at "grandfathered" product by the Agency is one result. Current methods are claimed to not be providing the product safety or efficacy seemingly promised. For most companies, the fixes are not rocket-science, but require the implementation of formal methods with documented and defensible rationale.

Areas Covered in the Session:
  • FDA Device Clearance / Changes in Direction
  • Product Changes and Filing a New 510(k) Responsibilities
  • Tracking / Evaluating Changes and the "Tipping Point"
  • "Risk-Based"
  • FDA's K97-1 and "Decision Tree" Model / Matrix
  • Resolving a "Wrong" Decision
Who Will Benefit:
  • Senior management in Devices and Combo Products
  • QA
  • RA
  • R&D
  • Engineering
  • Production
  • Operations
 
 
Organized by: GlobalCompliancePanel
Invited Speakers: 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. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.
 
Deadline for Abstracts: 2011-02-23
 
Registration:
Wednesday, February 23, 2011  
10:00 AM PST | 01:00 PM EST
Live live online training only for one participant
Price: $245.00
 
 
 
Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
Price: $995.00
 

Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
 
E-mail: webinars@globalcompliancepanel.com
 
   
 
home   genetic news   bioinformatics   biotechnology   literature   journals   ethics   positions   events   sitemap
 
 
 

Generated by meetings and positions 5.0 by Kai Garlipp
WWW: Kai Garlipp, Frank S. Zollmann.
7.0 © 1995- HUM-MOLGEN. All rights reserved. Liability, Copyright and Imprint.