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Integrating Human Factors Engineering into Design Controls for Combination Products

Correctly defining, integrating and documenting the scope and timing of HFE activities are fundamental to risk management, regulatory compliance, customer satisfaction and liability control. This presentation will illustrate the human factors engineering implications and opportunities of the recently published FDA final rule (21 CFR Part 4) on current good manufacturing practice (CGMP) requirements applicable to combination products. In particular, it will provide a roadmap for how best to define, integrate and document HFE methodologies throughout the required Design Controls (21 CFR 820.30) activities.