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FDA Warning Letter or Audit Failure: How Do You Balance Internal Resource’s Existing Commitments so Remediation Activities are Not Compromised?

In many cases we see that individuals involved in assisting with remediation have their own normal day jobs along with other duties and responsibilities. These individuals are often pulled into the project in a matrix type of organization. It is very important that commitments are obtained with the resources from the internal organization. It is important to realistically commit a resource’s time. In order to support the remediation plan, which is the top priority, we recommend the organization bring in some extra contract support. This additional support will help manage some of the day-to-day duties and offload work normally completed by key subject matter experts involved in the remediation activities. It is normally the project manager’s responsibility to make sure the remediation plan has all the proper resource loading, resource assignments, and realistic commitments.

USDM Life Sciences has a combination of over 100 years in regulatory compliance, Quality Assurance, Quality Systems and auditing. USDM’s auditors in the Global Audits Practice Team perform audits on Pharmaceutical, Biotech and Medical Device companies in the US and abroad.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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