Auditing

As a Quality & Compliance Subject Matter Expert in the pharmaceutical, biotechnology, and medical device industries, Jim provides audits of clients' third party suppliers as well as their internal operations. These audits address several areas including:

cGMP
Supplier qualification, re-qualification, and for-cause audits
ISO 13485
Inspection readiness
GCP and GLP
Due diligence
Quality System assessments
Remote audits

Clients are provided with a detailed audit report, recommended corrective actions, and post-audit follow up. Additionally, a Corrective Action Plan will be provided if requested, and additional support given for remediation activities.