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Background A mid-sized company received a 10-item FDA Form 483 and submitted an initial response. However, the response was followed by the issuance of a Warning Letter, leaving the company...

A leading developer and manufacturer of affordable, high-quality generic pharmaceuticals, wanted to improve their document change process.

In this episode of RCA Radio, host Brandon Miller and Seyed Khorashahi, who is Regulatory Compliance Associates (RCA) Executive VP of Medical Device and CTO, provide an outlook into the...

Among the current and emerging topics of interest to the pharmaceutical industry, the topics of quality metrics, quality culture, and data integrity are of particular concern to both the industry...

Companies in almost every industry across the world have had to adjust due to the pandemic by moving key face-to-face activities during a virtual audit. In this episode of RCA...

A generic pharmaceutical manufacturer was interested in applying lean principles to the operation of the Quality team, with the objective to reduce the product release timeframe. However, they lacked internal...