Four Reasons to Automate SOP Management in FDA and ISO Environments

In FDA and ISO environments,there are multiple  reasons to consider automating SOP management. by David R. Butcher,  Marketing Communication...

7 Document Management Blunders that Jeopardize Compliance

Is bad document management spoiling  your compliance efforts? Learn how  to fix seven common document  management mistakes. by James Jardine...

FDA Issues New Draft Documents Related to Compounding of Human Drugs

FDA has issued five draft documents related to  drug compounding that are applicable to pharmacies,  federal facilit...

6 Ways to Ensure Your QMS Meets FDA and ISO Compliance

Optimizing their QMS will help companies  in  FDA  and ISO  environments realize maximum value  in their compliance efforts . by David R. Bu...

Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

Are you familiar with the draft guidance  on GMPs for combination products? by Suzanne M. O'Shea Counsel, Faegre Baker Daniels LLP Two ...

The Perks of Pursuing a Career in Quality Management

Don't fear the auditor!  Instead, become one!  Auditing can  lead to a variety of career paths in an organization. by Greg Peckford Foun...

Success By the Numbers (or Why Being Science-y is a Good Thing)

William Thomson, 1st Baron Kelvin, believed “the best  performance  of the everyday occupations of mankind  are those to which the principle...

FDA Audit Practices: the 10 Most Commonly Cited Drug GMP Deficiencies of 2012-2013

Does the word "audit" make you shake in your shoes? by Ken Christie COO, VTS Consultants, Inc. If there is one word within the lif...

CAPA Should Not Be a Dreaded Four-Letter Word

A poorly maintained paper-based CAPA  process may contribute to FDA violations. by Cindy Fazzi Editor, MasterControl Insider In a regulated ...

Murray Explains ISO 9001 Update at MD&M West

Walt Murray makes learning about  ISO 9001 updates  interesting. Don't miss  his MD&M West presentation! by Robyn Barnes Marketing C...

Measuring Risk Management Outcomes

Being a risk manager in an organization  is a  thankless task---but you already  knew that, didn't you? by Rod Farrar Director, Paladin ...