JD Supra

FDA readies for QMSR implementation with draft QMS information guidance: What manufacturers need to know

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
JD Supra

FDA Signals Major Shift for QMSR Transition for Medical Device Applications

Drug & Device Team provides recommendations based on Food & Drug Administration (FDA) draft guidance on Quality Management System ...
Pharmabiz

IPC releases guidance document on Quality Management System in testing laboratory

The Indian Pharmacopoeia Commission (IPC) has released a guidance document on Quality Management System (QMS) in testing laboratory. QMS consists of documentation of the laboratory policy and ...
PharmTech

Quality management systems for small organizations: Reducing the headache

Many small pharma/biopharma companies do not understand what a QMS is and the benefits offered by such a system. To be effective, there are several key strategic elements and systems that a QMS must ...
Royal Society of Chemistry

Webinar On - Medical Devices and Pharmaceutical Quality Management System - Applying the Principles of Lean Documents and Lean Configuration

The Theory of Lean Documents is the product of applying lean principles to the Quality Management System (QMS) documents typically found in regulated industries. Just as lean principles challenge ...
Nature

Implementation of the JACIE standards for a haematopoietic progenitor cell transplantation programme: a cost analysis

The purpose of the present project was to analyse the costs incurred by the implementation of JACIE standards at a University Hospital with 1000 beds, performing some 40 autologous transplants per ...