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Mock Pre-Approval Inspection Audits

  • Prepare and conduct Mock Pre-Approval Inspection Audits

  • Prepare staff for inspection protocols 

  • Report potential inspectional findings and provide guidance to remediate deficiencies




GCP Audit

Good Clinical Consultants - GCP Audits, QMS

GCC will: 

Review SOPs for compliance within applicable regulations and guidelines and, if needed, create entirely new SOPs. 

Review computer systems procedures and documentation, including those for security, back-up, and recovery 

Review QA unit reporting structure, auditing practices, and CAPA procedures

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