Scaling Quality Compliance and Audits Across Global Networks

DDReg Knowledge Capsule · Jan 30, 2026 · 16m

📢 DDReg Knowledge Capsule – Episode [23]importance of maintaining rigorous oversight of external vendors within the international pharmaceutical and medical device sectors. It explains that regulatory bodies hold the primary product owners directly accountable for any quality failures, regardless of where manufacturing or material sourcing occurs. To mitigate these risks, the source advocates for a structured governance model that uses risk-based assessments to determine the intensity and frequency of supplier evaluations. Furthermore, it details how formal quality agreements, comprehensive…