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The Center for Professional Advancement, An Online Training Format
January 13, 2009 at 11:00 a.m. - 12:30 p.m. (EST)
Who Should Attend
This course is designed for professionals in the pharmaceutical, device and biologics industries. 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 pharmaceutical, biological and 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 are:
Module 1:
• Design Space: a new FDA concept that permits deviations
in design of medical devices and production processes
without regulatory involvement or re-approval
Module 2:
• Off Label Drugs: FDA crackdown on this process of large
scale use of a drug for treatment of a disease never
reviewed or approved
Module 3:
• Process Validation: Risk Based (Q8, Q9, Q10) and
Quality by Design new approaches
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 Independent Consultant to FDA Regulated Industries, has consulted for the FDA, Health Canada, NIH, CDC, EMEA and the Swiss Ministry of Health
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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