UL and MasterControl published “ISO 13485- Change? Do I have to?” article, by Emergo Expert Linda Chatwin and MasterControl Expert Walt Murray. Click here to view.
Guidance on Process Validation (PV 2011) uses the basic principles of scientific understanding put forth in ICHQ8—the foundation of Quality by Design (QbD)—to establish process understanding and link it to […]
A framework for quality auditing of a merger and acquisition (M&A) pre-acquisition due diligence investigation process. Who will head the acquired operation as represented by an independent investor will drive […]
Business is booming for nutraceuticals as consumers turn to vitamins, minerals, herbs, innovative foods and other natural products to improve their health. In 2017, the industry continued to embrace the […]
FDA’s mission is to help people make informed decisions about FDA-regulated products. The FDA does this by communicating directly with product users and prescribers while giving guidance to industries to […]
MDSAP is an acronym for Medical Device Single Audit Program. Pilot companies who are manufacturers either selling into Canada or who have operations in Canada could volunteer to have a […]
A supplier by any other name is still just a supplier!?…I’m amazed when I’m working with a 21st century regulated business that simply wants its buyers or procurement group to […]