One and a Half-day In-person Seminar: FDA Compliant GLP for Nonclinical Studies - For Pharmaceutical and Medical Device Industries 2012

  • 26-27 Jul 2012
  • Orlando Airport Marriott Lakeside, FL, United States

Description

Topics
  • Good laboratory practices: scope, objectives and definitions
  • US FDA GLP regulations and requirements
  • Facilities and equipment
  • Organization and personnel: personnel, management, study director and quality assurance unit
  • Test and control articles
  • Testing facilities operation: standard operating procedures (SOPs)
  • Records and reports
  • Protocol and conduct of a GLP study
  • Preparing for GLP inspection
  • Implementing GLPs
  • GLP workshop for GLP implementation
  • Numerous case studies for deficiencies and for improvement
Who should Attend
  • Product and development (associates, scientists, managers, directors and VPs)
  • Research and development (associates, scientists, managers, directors and VPs)
  • Quality assurance, quality control, and quality systems (associates, specialists, engineers, managers, directors and VPs)
  • Regulatory affairs (associates, specialists, managers, and directors)
  • Site managers, and consultants
  • Contract research organization (associates, scientists, managers, directors and VPs)
  • Contractors and subcontractors
  • Senior and executive management (VPs, SVPs, Presidents and CEOs)

Past Events

Important

Please, check "One and a Half-day In-person Seminar: FDA Compliant GLP for Nonclinical Studies - For Pharmaceutical and Medical Device Industries" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma

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