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.
- 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
- Clinical Safety/Pharmacovigilance Specialists
- Regulatory Affairs Professionals
- Quality Management Specialists
Steve Jolley
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1.5 hours; 1:00 - 2:30 p.m. Eastern
May 24, 2011
Hold this course at your company! For more information, contact Naila Ganatra at (215) 413-2471.