Inspection Readiness and Training

• Proactive inspection preparation
• CAPA inspection and audit responses.

Design and implementation of an effective inspection readiness program ensures ongoing compliance with SOPs and regulatory requirements.

Strategic Inspection Readiness Training delivered to line personnel and management, as well as clinical teams.

Mock Inspections prepare staff to face inspection interviews and document requests and can help identify best inspection leadership.

Accurate and actionable root cause analyses and ongoing effectiveness measures are key to a successful CAPA program.

Training:

Target Audiences: Clinical Trial Teams, Clinical Development Management, Clinical QA Professionals, Systems Developers and Programmers, Data Management, Document Management, Trial Monitors, Trial Statisticians.

½ Day to 3-Day Sessions can be delivered, customized for the client environment and priorities.