Project Description

We assisted a large pharmaceutical company with a muti-site, multi country, remediation project. The FDA issued the company a 483 and a Consent Decree due to alleged drug efficacy and possible adulteration. Several of our people worked as remediation leads for this large project. Some of our other consultants worked with cleaning validation, validation planning, quality review, risk management implementation, Project oversight, CD Reviewer, and CD Verifier.

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