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CfPA - The Center for Professional Advancement, Free Webinar/In Conjunction with Medical Device Summit
May 12, 2010 at 11:00 a.m.–12:00 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
Want to keep your medical device company ahead of the curve? Concerned about rumors of major changes in the FDA's Center for Devices and Radiological Health (CDRH)? Need to know the details of dramatic changes in FDA device approval and regulation policy? Join us for an advance look at the soon to be announced major changes in CDRH. You'll hear the latest inside information about organizational changes, shifts in 510(k) submission requirements; redefinition of "predicate devices" and FDA plans for reviewing grandfathered devices.
If you're designing, manufacturing, selling, or using a regulated medical device this program is an advanced look at the information you need to have.
The program includes:
• Major CDRH corruption charges
• Changes in the use of the 510(k) and 513 designations
• New requirements for providing device safety and efficacy
• Changes in "predicate device" interpretations
• Requirements for "grandfathered" devices
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Organized by:
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CfPA - 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. 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.
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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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sberg@cfpa.com
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