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If your company needs to strengthen investigation defensibility, eliminate repeat deviations, and move past "undetermined" or "human error" root causes, it is time to build true competence for your investigators and reviewers.
Business Excellence Consulting, a worldwide leader in investigations and CAPA remediation for the FDA-regulated industry, presents our Advanced Investigation and CAPA Program addressing:
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Determination of true root causes
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Implementation of effective CAPAs
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Ensuring robust Quality Unit oversight and governance in every investigation report
This highly structured program consists of three sequential steps designed to optimize your CAPA processes and ensure your investigation team is highly competent:
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Align & Train: We begin with best-in-class training based on our best-selling ASQ (American Society for Quality) books on investigation and human error reduction. Simultaneously, we review your current procedures to ensure total alignment with current FDA expectations.
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Coach & Review: We provide hands-on, prospective reviews and personalized coaching during your live investigation and writing processes. Our consultants work directly with your personnel to ensure every record is complete, adequate, and compliant.
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Certify: Finally, investigators and reviewers undergo formal certification. They will independently submit completed records for evaluation and grading against an approved protocol to prove self-sufficiency.
Are you available for a brief, 10-minute call next week to discuss how we can help your team reduce deviations?
Best regards,
Jose (Pepe) Rodriguez-Perez, PhD
President and Founder
+1.787.705.7272
pepe@calidadpr.com
www.bec-global.com
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