Quality system audit schedules are typically published at the beginning of each year; however, internal auditing personnel may find themselves unprepared when actual audit dates approach. In such instances, companies undertake last minute preparations of checklists and audit questions that generally take months to develop. This can lead to a rushed audit process where corrective […]
The Association for packaging and processing technologies, examined the latest trends impacting the pharmaceutical market. Global sales in 2016 have reached a record high for pharmaceutical sales at $1.1 Trillion, with North America alone generating $574 billion. The greatest influence on growth in the pharmaceutical industry is general economic development. As more people can afford […]
Companies worldwide are challenged with developing and maintaining efficient disciplined product labeling. They are tasked with a wide range of internal requirements, Marketing and Product Branding and external regulatory requirements, such as GHS or UDI compliance requirements. As example, the chemical industry and their respective supply chains are continuously evolving and have as complex a […]
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When we talk about UDI in our industry, we always refer to the classes, Class 3, Class 2 and Class 1 UDI and we always reference the due dates. What gets lost in this discussion is the actual benefits that accompany UDI. When UDI is fully implemented there are benefits to multiple organizations: the organization […]
The healthcare industry has been rapidly preparing for FDA compliance requirements, on all medical devices (Class I-Class III.)— With the FDA’s latest deadline being completed for Class II devices this September, are you prepared for the Class I deadline? With each UDI deadline provide a new challenge for the medical device community. While many companies […]
Counterfeit pharmaceutical drugs is a billion dollar a year industry that has put a dark stain on the healthcare industry as the lack of regulatory standards has put patients lives at risk. As a result the FDA is trying to reduce and eliminate counterfeit drugs through the DSCSA (Drug Supply Chain Security Act.) Signed by […]