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Date: 5th June, 2008

Location: web seminar, USA

Summary:
Pharmaceutical - Seminar

This webinar will provide valuable assistance to individuals responsible for corporate compliance with FDA regulations. Companies whose operation is under the jurisdiction of the Food and Drug Administration are faced with a myriad of regulations with which to comply. How does a company know which requirements require the most attention? This webinar presents the most challenging compliance issues faced by companies, and sets forth methods to assure compliance.

Areas Covered in the seminar:

• Classification of compliance responsibilities.
  
• Which subsystems are the most difficult to bring into compliance?
  
• In what areas have these subsystems been found to be out of compliance?
  
• How are these subsystems interrelated?
  
• Procedures, processes, or documentation to put in place to facilitate compliance.
  

Who will benefit:

This webinar will provide valuable assistance to individuals responsible for corporate compliance with FDA regulations. The employees who will benefit include:

• Top Management
  
• Regulatory Management
  
• Quality Management
  
• Consultants
  

Instructor Profile:
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.