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Preparing for a Safety Inspection May 2011

May 24, 2011
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Course Description

To ensure compliance, regulatory authorities routinely conduct inspections of companies’ drug safety operations. To prepare for an inspection, you must perform a thorough drug safety and pharmacovigilance audit. An internal audit will assess your company’s compliance with applicable worldwide laws, regulations, and guidances. Indeed, regulatory inspectors will look for evidence that such an audit has taken place. This course will provide participants with practical strategies for preparing for a safety inspection at their company via an internal audit.

VideoPreview

 

Learning Objectives

  • Obtain the practical information needed to understand the applicable regulations and achieve compliance
  • Explain the impact of global regulations on international safety reporting and review methods
  • Describe the requirements of all applicable regulatory bodies for your company’s products

Who Should Attend

  • Clinical Safety/Pharmacovigilance Specialists
  • Regulatory Affairs Professionals
  • Quality Management Specialists

Instructor

Steve Jolley

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Course Length Time

1.5 hours; 1:00 - 2:30 p.m. Eastern

Course Dates

May 24, 2011

Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.