Facilities

08
Dec

A Virtual Solution: Lachman Consultants’ Webinar Details Top Strategies & Tools for Remote Auditing and FDA Inspection Preparation

The Coronavirus pandemic has forced organizations worldwide to adjust current business goals and objectives drastically. One priority that hasn’t changed for companies regulated by the FDA is inspection preparedness and compliance. Although this process typically requires working on-site with qualified third-party experts, auditing for FDA inspection preparedness can now occur over a remote connection as […]

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08
Apr
flying money

Out of Sight – Out of Mind – Not Hardly and No Refunds

FDA issues Guidance for Industry: “Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act, April 2020”. With all that’s going on with Covid-19, FDA is diligently executing their priorities for this fiscal year.  In FY19, FDA’s priorities for Compounding (human drugs) were to: maintain quality manufacturing and compliance; […]

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