Well-drafted, easy-to-understand quality records are crucial to helping pharmaceutical and medical device manufacturers navigate FDA inspection obstacles. The FDA relies heavily on information presented in inspection-implicated documents to determine whether a manufacturing operation is compliant with FDA's requirements... Read more
The notion that the role of Quality Assurance (QA) in clinical development should be relegated to reviews, audits and quality control (QC) checks is an antiquated one that could well run medical product developers afoul of FDA and... Read more
Are you a device or combination products manufacturer or service provider? AAMI has just released an important document mapping US 21CFR 820 to the Medical Device Standard ISO 13485. If you have not started or are behind in... Read more
Risk management is an essential activity for regulatory compliance within pharmaceutical and medical device companies. While it is often challenging for medical product manufacturers to incorporate risk-based principles into their quality and compliance approaches, it is essential that... Read more
After decades in the pharma, device, and biologics industry working in new product development quality; manufacturing quality; market quality and post market surveillance; and quality systems my answer can be summed up in one word. Watermelon. yes, watermelon.... Read more
Why do good manufacturing operations have bad inspections? FDA warning letters and 483s are rife with references to manufacturing controls and batch failures; to SOPs and QC procedures; and to complaint handling and CAPA investigations. But in many,... Read more
Well designed and executed quality systems are the foundation of compliance for the highly regulated pharmaceutical and medical device industries. Still, many companies struggle to build strong, functional quality systems, instead creating various regulatory versions of the Winchester... Read more
There are no FDA regulations governing writing quality or clarity. FDA Investigators will never note “poor writing” as a 483 observation or warning letter citation. But when it comes to regulated manufacturing operations, the FDA’s rule of thumb is... Read more
