Preparing for a Safety Inspection

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 web seminar 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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$695

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call 1-800-856-2556 for pricing.

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will mail ACPE statements within three weeks of program completion.  ACPE#: 0778-0000-14-028-L01-P.  Released: 6/14.  

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