| |
|
|
|
The Center for Professional Advancement, 90 Minute Accredited Online Training
December 1, 2009 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
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. Join CfPA each quarter for the latest FDA guidelines focused on the medical device industry– 90 minutes with an expert who can help you assimilate the information and answer your questions.
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 update. It will be especially beneficial to:
• Regulatory/QA Managers
• Directors and VPs
• Planning Executives anticipating FDA changes Description
This quarter's briefing is a careful distillation identifying the three most important new initiatives, regulatory changes and innovations from the FDA, and places them in context for the medical device professional. This 90-minute accredited online training is divided into three sections, each section devoted to a new FDA regulation or initiative. The topics for this quarter are:
Module 1: Major revisions:
• De Facto Elimination of 510(k)
• Center Reorganization
• New Clinical Testing Requirements
Module 2: Post market surveillance:
• Reporting Form Changes
• Long Term Testing
• Grandfathered Devices
Module 3: International harmonization:
• Progress with EMEA
• Predicate Device Set Backs
• Japan Harmonization Update
Question and Answer Session
|
|
|
|
|
|
|
|
Organized by:
|
|
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:
|
|
salbers@cfpa.com
|
|
|
|
|
|
|
|
|