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US Medical Devices Seminar

 
  July 25, 2008  
     
 
SPI USA, Inc., Bloomington, Indiana
Nov 6-7


  • FDA Overview
    1. Device Risk Classification & the Approval Process
    2. Pre-market notification, 510(k)
    3. Pre-market Approval (PMA)
    4. Interacting with the FDA - From Regulations to Reality: A former FDA Reviewer's perspective
  • Pre-Clinical Considerations for FDA Submissions
    1. Developing a successful strategy
    2. Standards and guidance
    3. Technical Report Writing
  • Combination Products
    1. Regulatory Challenges
    2. Examples of drugs/biologics device combinations
    3. Case study: Drug Eluting Stents
  • Quality Systems Regulations
    1. Purpose of Quality System
    2. The Quality System Regulations (QSRs)
    3. ISO 13485
    4. Combination Products: QSRs and CGMPs
  • Chemistry, Manufacturing and Controls (CMC)
    1. Contents of the CMC Section
    2. Case Studies
  • FDA Inspections
    1. The QSIT Process
    2. Preparation for an Inspection
    3. What Happens During the Inspection
    4. After the Inspec
  
 
 
Organized by: SPI USA
Invited Speakers: Dr. Semih Oktay, former scientific reviewer at the U.S. Food and Drug Administration (FDA) and President and founder of CardioMed Device Consultants, LLC, will present this training seminar. Below is a synopsis of Dr. Oktay's credentials:

Worked for six years as an expert mechanical engineer and scientific reviewer for the FDA in the Office of Device Evaluation, Interventional Cardiology Devices Branch;

Served as primary reviewer in the product areas of coronary stents, peripheral stents, and balloon angioplasty catheters;

Represented the Agency at numerous panel advisory meetings, scientific symposia, policy conferences, and voluntary standards development organization meetings;

Provided consulting support and guidance in the areas of mechanical engineering, material science and medical device regulations to other FDA offices, U.S. governmental agencies, and international regulatory agencies;

Received both individual and group recognition awards from the Agency;

Experienced in interpreting and evaluating engineering data, developing and presenting reports of scientific review, and devising and modifying guidelines and protocols for the testing of medical devices;

He is also an Adjunct Faculty at the University of Maryland Baltimore County and his research interests are in coronary stents, balloon angioplasty and the effects of balloon angioplasty on coronary arteries.



 
Deadline for Abstracts: -
 
Registration: Please consult our website (www.usaspi.com) or contact us at seminars@usaspi.com or (714) 924 0155
E-mail: spiusa-washington@usaspi.com
 
   
 
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