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Blog & Updates

July 23, 2015

GxP Audits Overview

The differences in good clinical practice, good laboratory practice, and good manufacturing practice audits Audits are a mainstay in the pharmaceutical industry. Virtually every pharmaceutical company is subject to them at one time or another. However, different audits exist depending on the regulations being evaluated. Some audits are designed to address Good Clinical Practices, whereas […]

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Regulatory compliance training is important for personnel in a pharmaceutical company to remain current with appropriate regulations. In preparation for announced and unannounced inspections by the Food and Drug Administration or other regulatory agencies, personnel need familiarity with the latest national and international guidelines. As such, pharmaceutical and medical device executives should understand what features […]

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Virtually every device manufacturer that conducts studies on humans needs to determine whether an investigational device exemption is necessary. As such, device manufacturers should understand what an investigational device exemption is, to which devices it applies, and how to obtain an investigational device exemption if it is needed. What is an Investigational Device Exemption? An […]

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An overall goal of pharmaceutical executives is to ensure that the products developed by their companies are approved by the appropriate agencies and marketed appropriately. However, this can pose a challenge given the changing guidelines of agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency. At best, not following these […]

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While the Medical Device Single Audit Program (MDSAP) is still being piloted, it is crucial for medical device manufacturers to understand the potential benefits and implications of an international single audit program. There are many advantages to a MDSAP for both the medical device manufacturer and regulatory authorities. Developed by the International Medical Device Regulators […]

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