The Parenteral Drug Association conducted an anonymous global survey of quality culture
in the pharmaceutical industry to determine whether there is a relationship between certain …

Quality culture as an enabler of high-quality performance and subsequently as a source of
competitive advantage is increasingly discussed among operational excellence (OPEX) and …

1.1 Background The 2012 Food Drug Administration Safety and Innovation Act (FDASIA)
gave FDA new tools to encourage high quality manufacturing of pharmaceuticals and …

Background PDA published its “Quality Culture Survey Report” in the PDA JPST in 2015 (1)
and presented the findings at the “Joint PDA FDA Quality Metrics Conference” that same year…

… Authors: Members of the PDA Task Force Post Approval Changes for Innovation in
Availability of Medicines (PAC iAM), Emma Ramnarine, Ursula Busse, Marcello Colao, Julia …

The Parenteral Drug Association (PDA) has identified 11 current questions related to data
management and control that have been frequently cited in US Food and Drug Administration (…

By Denyse Baker ata integrity has been and currently is a major global concern of health
authorities and the pharmaceutical industry. Although not a new issue, numerous recent health …

… Denyse BAKER, Jeff BROADFOOT …

INFORMATION TO USERS Page 1 INFORMATION TO USERS This manuscript has been
reproduced from the microfilm master. UMI films the text directly from the original or copy …

This presentation provides an overview of the evolution of these guidance documents, along
with a review of the data elements in the most recent draft guidance and the metrics FDA …