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Preparing for the Device Industry's 513 Exemption Changes

 
  May 12, 2010  
     
 
CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training/In Conjunction with Medical Device Summit
June 3, 2010 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend
This course is designed for professionals primarily in the medical device industry. However, interested parties in the pharmaceutical and biotechnology and biologics fields will also benefit from this training. It will be especially beneficial to:

  • Regulatory/QA Managers 
  • Directors and VPs 
  • Planning Executives

Description
According to the FDA “Medical devices distributed in the United Sates are subject to General Controls, pre-marketing and post marketing regulatory controls.” New FDA guidelines, regulations and interpretations emerge constantly from the agency that controls almost a third of the US economy. Keeping up with these changes is a constant challenge. This 90-minute accredited online training will address the most recent changes related to the 513 Exemptions. Special attention will be given to the application process, a review of the criteria for approval and the 510k strategies.

Module 1: How to apply:
  • The 510(k) medical device process
  • Pre market approval criteria
  • Exemptions: the 513 clause

Module 2: Criteria for Approval:
  • Submitting the 513
  • FDA review criteria
  • Importance of predicate devices

Module 3: 510(k) Strategy:
  • Value of the PMA
  • Proving safety and efficacy
  • Special cases

Question and Answer Session


About Medical Device Summit 
Medical Device Summit publishes news, technology, trends, regulations, and opinions, as well as offers educational, career advancement and networking opportunities to the global medical device and diagnostics industry. This information exchange is facilitated through ePublishing, digital and live events. By providing such an exchange of knowledge and technologies, MedicalDeviceSummit hopes to help advance the progress of the global medical device and diagnostic industry, thus, contributing to a healthier world.

MedicalDeviceSummit.com is an online meeting place and industry specific web site for the global medical device industry. The content is a mix of journalistic-style articles, technical articles, blogs, white papers, press releases and news.

For more information visit their website atwww.medicaldevicesummit.com or email rbiros@InnovativePublishing.net.

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Dr. Sandy Weinberg, Associate Professor of Health Care Management (Regulation) at Clayton State University, part of the Georgia State University System; retired regulatory professional from the drug, device and vaccine industries

Dr. Weinberg is teaching and researching Regulation and Biodefense. He is a consultant to the FDA regulated industries and is a former consultant to the FDA and other international regulatory agencies including Health Canada, NIH, CDC, EMEA and the Swiss Ministry of Health.

He has been a leader in the field of system validation for more than twenty years, and a practitioner in regulatory submissions, auditing, international liaison and biodefense vaccine development. Dr. Weinberg is the author of numerous books and articles, including The GALP Regulatory Handbook, The Handbook of System Validation, Good Laboratory Practice Regulations, and The Handbook of Drug Regulatory Submissions. His most recent articles include “Cost Effective Validation for LIMS” and “Conforming to Part 11 Regulations”.

Dr. Weinberg is a member of the Board of the KEMA Registered Quality (ISO 9000 Certifier) in the United States and the Netherlands. Recently retired, Dr. Weinberg was Senior Director for Biodefense at GE Healthcare and Vice President of Tikvah Therapeutics; as well as an investor in and Board member of several international biomedical companies.

Working as a consultant, Dr. Weinberg provides auditing and advisory services in regulatory areas. Recent projects include the auditing and certification of a chromatography control system; a business development and fund raising project for a biodefense vaccine company; an Orphan Drug submission; and the validation of a Laboratory Information Management System. Much of Dr. Weinberg’s practice is centered in the US, Western Europe and Israel.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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