For life science manufacturers concerned about third-party access to facilities, we have been recommending they add pre-entrance gowning to existing gowning procedures and extend the gowning envelope to the building exterior. This can be accomplished through an expedited... Read more
The Opportunity Cost of Swapping Staff from One Project to Another: The need to constantly swap internal resources to keep projects on-track can severely limit FDA-regulated companies from maintaining quality and staying in compliance. Instead of improving operations,... Read more
The FDA has long taken a risk management approach to enforcement actions, as well as requiring drug and medical device manufacturers to do the same in their quality systems operations. Companies can turn the same risk management approach... Read more
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 myriad data to agency investigators, which expect that data to meet its... Read more
Data drives the pharmaceutical and medical device industries. It informs the manufacture and release of medical products to patients and consumers, and determines which products are approved for sale in the US and other markets. And regulators, like... 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
