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The Center for Professional Advancement, 90 Minute Accredited Online Training
January 20, 2010 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training is valuable to professionals in the Medical Device industry.
It will be especially worthwhile to personnel involved in medical device manufacturing, medical device design, executives, managers and regulatory professionals. Description
This 90-minute accredited online training will focus on the upcoming major changes in the criteria and focus of the Medical Device registration and review process within the FDA.
Module 1: The Root of the Problem
• Why the major revision?
– What is driving the concerns in what was the “model”
FDA division?
• Internal dissent:
– What caused Medical Device FDA people to raise
problems?
• The grandfathering dilemma:
– Are devices on the market without adequate testing?
– Are untested devices being used as predicates to
approve new products?
Module 2: What's Coming?
• Changes in predicates:
– To what extent should predicates be accepted?
– What changes are needed to assure safety?
• Pre-1976 devices:
– Are early predicates appropriate controls?
• Clinical (PMA) testing:
– When is a 510(k) not sufficient?
– What should trigger a Premarket Approval clinical
student?
Module 3: What to expect?
• New regulations:
– What's coming, when
• New harmonization:
– How will these changes affect harmonization with
EMEA guidelines?
• New interpretations:
– How will the FDA review applications?
Question and Answer Session
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Organized by:
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The Center for Professional Advancement |
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Invited Speakers:
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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. Sandy Weinberg, is currently a professor of Health Care Management in the School for Professional Studies at Clayton State University, part of the Georgia State University System. He is teaching and researching Regulation and Biodefense. Dr. Weinberg 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.
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Deadline for Abstracts:
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n/a
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Registration:
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Please click here for registration information.
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E-mail:
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salbers@cfpa.com
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