The second part of this three-part series on executing an effective remediation program starts by looking at primary versus secondary root causes. A robust quality system provides an assurance of high-quality production efforts and products. NSF recommends that a systems-based approach to remediation and corrective action is the most successful approach. Also, a system- based approach is recognised globally with, regulators such as the MHRA and FDA.
Executing a successful remediation program: part 2 of 3
Learn how NSF's Pharma Biotech experts help clients with remediation strategy, including FDA Warning Letters.
