The FDA's metrics program is intended
to improve the quality of drugs. by Stephanie Gaulding, CQA, CPGP
Note: The original version of this article was published on my LinkedIn profile on February 23, 2017. Another version was published in the July/August 2017 issue of PDA Letter.
I had the pleasure spending two days...
ASQ speaker Jack Hamilton shared best practices
for avoiding problems in managing
corrective and preventive action (CAPA) systems. by James Jardine
MasterControl Staff Writer
At a recent ASQ Salt Lake Section symposium held at the headquarters of quality management software solutions provider MasterControl in Salt Lake City, food safety...
Although it may identify problems and
facilitate ways to resolve them, a quality
control system alone does not ensure quality.
by David R. Butcher
Staff Writer MasterControl
For organizations doing business in regulatory environments, successful quality assurance and quality control are crucial aspects of quality management in FDA- and...
The device and pharma industries must prepare to merge on the path to the combo product market. by Alex Butler
Manager, Medical Device Solutions
Thanks to constant leaps in scientific and technological innovation in recent years, we’re witnessing a steady (and very promising) trend toward combination products – those that...
Be ready for an inspection or audit by
training employees on the four
communication pillars: preparedness,
patience, directness and details. by UL
When an FDA inspector comes to your door, it is usually a time of stress and uncertainty. You need to handle logistical elements like where the inspectors are going to be placed, how you will...
A company’s ROI from an online training
program can be substantial and immediate! by Greg Peckford
Founder, Quality Career Advancement
Is the quality manager the only individual within an organization that requires training on quality and improvement methods? Absolutely not! In order for an organization to get the most value out of their...
Implement cybersecurity at the grassroots
level of medical device development
by David Jensen
MasterControl Staff Writer
Cybersecurity is like a maze that companies in all industries need to navigate to avoid costly security breaches. The challenge is knowing where and how to get started. An FDA official shared some valuable insight on the...
Budget constraints constantly evolve
through an organization's lifecycle. by Keith Matthews
Director, Quality Systems
Regulatory Compliance Associates Inc.
Insights on driving value from staffing, automation and continuous improvement
Developing a quality system is the foundation for ensuring the organization’s products or services are...
Pharmaceutical, healthcare delivery and
food-related supply chains have a
critical and important mission of insuring
agility, resiliency and more timely
and successful business outcomes. by Bob Ferrari Managing Director, The Ferrari Consulting and Research Group
Founder and Executive Editor, Supply Chain Matters blog
Let me begin this...
FDA issued final guidance for Current
Good Manufacturing Products earlier this
year. An EpiPen is an example of
a combination product. by Dr. Karl M. Kapp
Department of Instructional Technology
At the beginning of this year, the FDA issued final guidance for Current Good Manufacturing Practice (CGMPs) Requirements...