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From GlobalCompliancePanel
Responding to FDA 483s - Webinar By GlobalCompliancePanel
Many companies know that a written response is required when the company is issued a 483 by FDA, but they do not know or understand the importance of timing and the response wording.
Wednesday, November 30, 2011
10: 00 AM PST | 01: 00 PM EST
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Off-Label Promotion of Drugs - Regulatory Documents Explained - Webinar By GlobalCompliancePanel
Overview: Promoting a drug or device for a use not approved by the Food and Drug Administration is illegal. As a result of this practice, called "off-label promotion," life sciences companies have been fined unprecedented amounts of money and their executives have been prosecuted criminally.
In addition to the regulatory and criminal consequences of off-label promotion, companies that promote
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Effective Essential CAPA process to avoid FDA 483 - Webinar by GlobalCompliancePanel
How do you prevent becoming another FDA statistic? Poor corrective and preventive action (CA/ PA) and investigations continue to be among top FDA Form 483 deficiencies issued to drug, biologic, and medical device manufacturers. It's in everyone's self interest to improve the quality of investigations and CA/ PA. This webinar will provide regulated companies the core principles and practices needed
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