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Audit Services

Facility Design Manufacturing Quality Audit Training Due Diligence FDA / CMC

     

Auditing functions are the responsibility of the Quality organization.  Our firm provides assistance in the following areas:
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Contractor and vendor audits

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Preparation of a pre-audit questionnaire to request specific information from the contractor or vendor.

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On-site visit accompanying a client quality representative (or independently) to assess the level of cGMP (QSR) compliance of the contractor or vendor.  The audit will review any outstanding issues or concerns associated with the contractor or vendor's previous services or products.

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Preparation of an audit report including any negative observations or "audit findings."  The report will contain a summary evaluation of the contractor or vendor's compliance status and recommendations.

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Participation in a reaudit of the contractor or vendor as requested by the client.

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Preparation for a regulatory inspection - Assistance to a client organization as it prepares for an FDA inspection or inspection by another regulatory authority, e.g. the FDB in California.

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Review of quality and document systems for completeness and regulatory compliance.

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Assistance in the development and review of an introductory presentation for the inspector.  This is appropriate for a scheduled inspection, e.g. Pre-Approval Inspection (PAI).

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On-site "mock" inspection of the facility, quality and manufacturing organizations.  Preparation of a report listing the findings of the mock inspection and suggestions to improve compliance.

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Attendance at the actual regulatory inspection as a "silent observer."  As a consultant, I may only help interpret the inspector's questions or concerns.  I may not provide any direct input into the inspection process.

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Assistance after an inspection to correct outstanding problems or issues and to help prepare response documents addressing any negative observations or "483s."

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Internal Audits

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We provide assistance in the establishment of an internal auditing program for our clients.

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We do not participate in the actual internal auditing process, as this should be the sole responsibility of the quality organization.

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