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Auditing and Remediation

Auditing and Remediation

Experts in Auditing and Remediation Processes

Quality Audits in the Pharmaceutical and Biotechnology Industry are necessary and extremely important in the industry. To be sure you are in compliance, an expert in the field is a must. Contact Joan Sutera of J. Sutera Consulting to assist you with your needs.

J. Sutera Consulting will:

  • Perform Regulatory Inspection Readiness, Mock Audits, Process & Risk Assessments.
  • Conduct Internal and Third Party Audits with detailed organizational skills and an acute sense of priority.
  • Has the ability to address FDA-483 observations and management.
  • Pre-Approval Inspections, Regulatory Readiness, Inspection Remediation
  • Conduct Data Integrity Assessments, and Mock Audits

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