Impact of FDASIA – New Quality Agreements Guideline, and Compliance Program Guide Sec. 490.100 for Process Validation | Aug. 7, 2022, 2 PM EST | Medina
FDASIA is legislation signed into law on July 9, 2012 that amends several drug and device provisions of the FD&C Act. By specifically addressing Drug Supply Chain, it enhances FDA’s authority over a manufacturer’s supply chain while strengthening FDA’sadulteration laws. In addition, FDASIA increases FDA’s authority over registered and unregistered foreign firms. Most significantly, this […]
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How to Write FDA-Compliant SOPs | Oct. 9, 2013, 1 PM EDT | Bazigos
Standard Operating Procedures (SOPs) are required according to FDA cGMP regulations for companies that are regulated by the Code of Federal Regulations such as Title 21 and Title 493. Yet, surprisingly, there is no guidance on how to write, organize and maintain SOPs. Consequently, SOPs are frequently written in a way that makes compliance difficult […]
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