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The Center for Professional Advancement, 90 Minute Accredited Online Training
December 8, 2009 at 11:00 a.m.–12:30 p.m. (ET)
Who Should Attend
This online course is intended for professionals in the pharmaceutical, medical device and biologics industries. Personnel involved in the submissions of NDAs, ANDAs, BLAs and PMAs will find this course valuable. The content will be especially beneficial to personnel within the following categories:
• Business managers
• Executives
• Regulatory professionals
• VCs Description
This 90-minute accredited training course provides a primer in the FDA submissions process for pharmaceutical, device, and biologics companies.
If you are considering an NDA, ANDA, BLA, or 501(k)PMA here is the essential information you need to plan the process and maximize success. An entire module of this course will be dedicated to a thorough explanation of the critical five steps needed to ensure a successful FDA submission process.
Module 1: The Five Critical Steps:
• Planning
• Pre-submission meetings
• Submission for approval to conduct clinical tests
• Submission for drug/biologic/device
• Follow up
Module 2: IND and IDE Submissions:
• Submissions criteria
• The process
• Maximizing approval potential
Module 3: NDAs, ANDAs, PMAs, BLAs
• The process
• Maximizing approval potential
• Issues:
– labels
– post-marketing
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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