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PMP Practice: Determine necessary approach and action to address compliance needs

Bo-Wen Fang is managing a pharmaceutical manufacturing expansion project for Eamon Doyle-Brennan Biotech. The project involves constructing a new sterile production facility that must comply with FDA Good Manufacturing Practice (GMP) regulations. The regulatory framework requires extensive documentation at predefined milestones, formal validation protocols before equipment commissioning, and government inspections at specific construction phases. A team member with agile experience suggests adopting an iterative approach with two-week sprints to improve team engagement and flexibility. The construction permit requires approved architectural drawings before foundation work begins, and the FDA has scheduled compliance audits tied to specific completion gates. What approach should Bo-Wen recommend for managing this project?

Key Concept

This question covers Determine necessary approach and action to address compliance needs under Plan and Manage Project Compliance (Business Environment).

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