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The Center for Professional Advancement, An Online Training Format
July 1, 2008 at 11:00 a.m. - 12:30 p.m. (EST–New York time)
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. Ample time has been allotted to answer your questions. The topics are:
PUBLIC ADVERTISING GUIDELINES:
Congressional mandate: 2007 Act
Problems and value of public advertising: Information dissemination, Public demand, over-use
FDA monitoring: Shift from FTC, Expertise gap
Emerging guidelines: Clarity, Information without “sales pitch”, Dangers and side effects
GMP AND 21 CFR PART 11 REVISIONS:
Harmonization with EMEA GAMP4/5:GAMP4= cGMP+Part11
Updating of GMPs in automated environment: More than ten years since last update, Risk factors
PAT: Automation of QA function, Potential for remote monitoring
POST MARKET SURVEILLANCE REQUIREMENTS:
Extension of FDA focus: Reduce NDA/ANDA pressure, Increased most market surveillance
Improved data collection and analysis: Active rather than passive, Tracking use, side effects, Possible post clinical studies (Phase V?)
Concerns over off label use: Reconciling distribution volume
Post NDA/ANDA submission and review: New FDA responsibility, New submission guidelines
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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info@cfpa.com
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