What is a Quality Manual? A Quality Manual is an authorized document created by a business, detailing how its quality management system operates. In other words, it’s a Table of Document Contents and ...

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, details regulatory requirements for developing a quality manual. and not just the quality department, similar to how the ...

Is your medical device company ready for the QMSR shift? Engineer Aldo Vidinha explains why "checkbox compliance" is over and how the FDA’s alignment with ISO 13485 redefines quality as a connected, ...

Grace McNally, in the Office of Compliance at FDA's CDER, discusses the role of QbD and pharmaceutical quality systems as it relates to contract manufacturing. The US Food and Drug Administration's ...