The Drug Supply Chain Security Act: Current Impact

The Drug Supply Chain Security Act is the most  complex pharma track and trace law ever passed. by David Dills Sr. Consultant, Regulatory ...

Training Effectiveness – A Quality by Design Approach

You can provide all kinds of training  for your employees but how do  you measure its effectiveness? By Holly DeIaco-Smith, MS  HDS Consult...

Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

Can't find the right lid for the barrel?  You might find  a different lid that almost fits and use duct tape. But if  you do,  chances a...

The CAPA Detective

In the GMP world, the CAPA investigator  is the detective, identifying how and  why manufacturing defects occur. by Laurie Meehan Social Med...

Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

Preparing for an inspection will help ensure a smoother,  less stressful experience. A mock inspection is a useful practice tool. by Kelly T...

7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

Human error is responsible for more than  80 percent of failures and defects.  by Ginette Colazzo President of Ginette M. Collazo, Inc. Huma...

Tales from the Front

Sometimes it’s your company that forces  a new direction during the inspection,  sometimes it the auditor. Sometimes it’s both. Adventures o...

Don’t Call Me Jim Cramer but Here are My Top 5 Pharma Trends

Pharmaceutical production costs are rising  because companies  have more hurdles  to pass during the testing phase. by Lane Hirning Product ...

The ISO 9001:2015 Change Train is Gathering Steam

Big changes are coming to ISO 9001.   Prepare to jump on this change train! by Robyn Barnes Marketing Communications, MasterControl ISO chan...

Draft Guidance on Good Manufacturing Practices for Combination Products – FDA Delivers on Promises

Are you familiar with the draft guidance  on GMPs for combination products?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 ...

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...