Being able to present data that the FDA believes it can trust is critical to making it through an inspection unscathed. Medical product manufacturers must provide a host of data to agency investigators, which expect that data to... Read more
Data drives the pharma and medical device industries. It informs the manufacture and release to consumers of medical products and determines which products are approved for sale in the US and other markets. And regulators like the FDA rely... Read more
The FDA and other global regulators rely on reviews of data during inspections to determine whether a pharmaceutical or medical device manufacturer is operating within regulatory requirements and expectations. The credibility of that data is a crucial parameter in the regulator’s assessment of whether... Read more
Savvy companies already understand that Quality Assurance (QA) must be integrated into the clinical development system, not relegated to an afterthought of audits and quality control (QC) checks. But exactly how should this be accomplished? Review of current... Read more
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
