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FDA Briefing–September 2011

 
  July 25, 2011  
     
 
CfPA - The Center for Professional Advancement, 90 Minute Accredited Online Training
September 13, 2011 at 11:00 a.m.–12:30 p.m. (ET)


Who Should Attend
New FDA guidelines, regulations, and interpretations emerge constantly from the agency that controls almost a third of the US economy. Keeping up with these changes is a constant challenge. Join CfPA regularly for the latest FDA guidelines—90 minutes with an expert who can help you assimilate the information and answer your questions.

This course is designed for professionals in the pharmaceutical, device, biologics, food and dietary supplement industries. It will be especially beneficial to:

  • Regulatory/QA Managers 
  • Directors and VPs 
  • Planning Executives anticipating FDA changes

Description
This 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. Counterfeit Drugs, The Food Safety Modernization Act (FSMA), and Mobile Medical Apps are the topics for this training session. This training will include opportunities for learning assessment.

Review of learning objectives
Module 1: Counterfeit Drugs:

  • Risks of Counterfeit drugs
  • On-line drug problem
  • FDA’s newest Initiative to combat counterfeit drugs
  • What’s Next?

Module 2: Food Safety Modernization Act (FSMA):
  •Goals and Purpose
  •Implementation Timeline
  •Draft Guidance
    – Dietary Supplements
  •Budgetary issues: FDA financial triage
  •What’s Next?

Module 3: Mobile Medical Apps:
  •Guidance timeline
  •Lower-level vs. high-risk health apps
  •Medical device classification and review process
  •What’s Next?

Question and Answer Session

 
 
Organized by: CfPA - The Center for Professional Advancement
Invited Speakers: Dr. Sandy Weinberg, Associate Professor of Healthcare Management, Clayton State University

Dr. Sandy Weinberg, with 25+ years of FDA regulatory experience, is a professor of Health Care Management at the School for Professional Studies of Clayton State University, part of the Georgia State University System. He is teaching and researching Regulation and Biodefense. 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. He has consulted to the FDA, most other regulatory agencies worldwide, and the industry. 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.
 
Deadline for Abstracts: n/a
 
Registration: Please click here for registration information.
E-mail: sberg@cfpa.com
 
   
 
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