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The Center for Professional Advancement, 90 Minute Accredited Online Training
October 22, 2009 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online training course is intended for professionals in the pharmaceutical industry. It will be especially valuable to:
• CMOs, Contract Manufacturing Organizations
• CMC specialists
• Pharmaceutical manufacturing organizations
• Regulatory affairs professionals
Description
This 90-minute accredited online training explores the root causes of quality concerns with China API and pharmaceutical product. Discussions will include the FDA's current and planned response to this issue. Decision formulae for determining whether or not to use China-based suppliers will also be addressed.
Module 1: FDA Concerns about China quality control
• Past problems with contaminants
• Independence of inspectors
• Corruption issues
Module 2: Root causes of China quality problems
• Factory design
• Capitalism run amuck: short term gain vs.
long term relationships
• Government over-control
Module 3: To use of not to use: how to answer the question
• Increased independent surveillance
• Corruption controls
• Re-test and QbD control
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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