September 16, 2020
Guidance Inartfully Mixes New and Old Expectations – Creates Confusion for Drug and Biologics Manufacturers As the COVID-19 pandemic continues, FDA continues its efforts to steward public health decision-making in an increasingly challenging regulatory climate. FDA’s most recent guidance for drug and biologics manufacturers was released late last week. The new compliant-manufacturing resumption guidance covers […]
May 5, 2020
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 change control – and should incorporate risk-based considerations. Objectives & Principles for Leveraging Expedited Change Control The […]
April 17, 2020
Navigating the challenges of staffing within FDA-regulated companies requires strategic considerations to avoid setbacks and maintain operational excellence. From the opportunity costs associated with internal resource swapping to the necessity of filling new or rebuilt roles effectively, executives face critical decisions that impact compliance and productivity. By leveraging executive placement firms, companies can mitigate risks […]
March 27, 2020
The FDA has long taken a risk-based approach to manufacturer GMP compliance expectations and enforcement actions, as well as requiring pharmaceutical and medical device manufacturers to do the same in their quality system operations. Similarly, companies can also use risk management approaches to rapidly reduce organizational risk in their data integrity efforts, by directing their […]
March 26, 2020
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 standards for being attributable, legible, contemporaneous, original and accurate (ALCOA) — characteristics that add up to data […]
March 3, 2020
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 the FDA, rely on data to determine whether a manufacturing operation is compliant with cGMP and QSR […]
© 2009-2025 Compliance Architects Holdings LLC – used by permission. All copyrights, trademarks and other intellectual property are the property of Compliance Architects Holdings LLC and are used by permission.
