Resolutions for Pharma Quality AssuranceI will give myself permission to expect more out of management...
Fri, 01/13/2012 - 13:46
Like anyone else, when I plan for the new year, I need to set aside time for reflection and anticipation. I look back and ask, “Have I made a difference in anyone’s life?” I look forward and ask, “What do I want to change that I either have control… Top 10 Ways to Make GMP Training Relevant Turn these negatives into positives and watch amazing things happen
Fri, 10/21/2011 - 15:09
Most good manufacturing practices (GMP) training that I encounter is not necessarily bad, just irrelevant. In fact, the same could be said for most training departments. They jealously guard their turf and deliver mediocre, perfunctory training.… Decisions and Indecision—The Organizational VortexNothing is more revealing about leadership and how decisions are made
Fri, 08/26/2011 - 09:58
The cover of Fortune magazine popped off the newsstand shelf last week [Aug. 15, 2011] with the article, “What Happened at Pfizer: The Inside Story of Revenge, Betrayal, and Power at the Top of the World’s Largest Drug Company.”
Amidst the story… Quality, Cost, and Speed: Can There Be a Balanced Decision?Great companies should have an advocate for each
Mon, 08/08/2011 - 12:20
The truism, “Quality, cost, and speed—pick two,” was often quoted throughout my career: meaning a production company could not achieve all three ideals and therefore must choose which two out of three ideals to concentrate on;
• Sacrifice quality… Should Commitments Made to the FDA Be Taken Seriously?There’s no excuse for poor responses or missed deadlines
Fri, 07/22/2011 - 15:42
Responses to the Food and Drug Administration’s (FDA) Warning Letters and the FD483—a written notice of deficiencies found during inspections—are usually full of commitments. They involve what will be done to correct compliance problems, and when… FDA Demands Corporate Commitment at PolyCarbon IndustriesWarning letter says bosses are responsible for QMS
Tue, 06/21/2011 - 06:00
Just when you think that the Food and Drug Administration (FDA) has to stick to the script by quoting chapter and verse of current Good Manufacturing Practices (CGMPs), it gets very progressive and offers straight talk about corporate commitment and… What Does It Mean to Operate in a State of Control?There is nothing here about perfection
Mon, 06/06/2011 - 05:30
Once upon a time I asked, “What does it mean to operate in a state of control?” at an off-site “strategy” meeting of a senior management group. You know the kind of meeting that I'm talking about—one in which a working breakfast was followed by a… For Corrective Action Plans, Where Are the Resources?What sells at the FDA
Wed, 05/18/2011 - 05:30
Can you imagine the stream of firms that venture into their respective FDA district offices to give presentations on their warning letter response and to offer their assurance that they truly “get it?” You can be sure these firms had several dry… FDA Questions Data Integrity at Ningbo SmartWhen the FDA uses the term ‘data integrity,’ it's too late to cook the books
Thu, 04/14/2011 - 06:00
A March 30, 2011, Food and Drug Administration (FDA) Warning Letter to Ningbo Smart Pharmaceutical Co. revealed that it had reported conformance to specifications on certificates of analysis, when in fact no testing was done—among other issues.
The… Consent Decrees—When the FDA Gets Tired of TalkingCompanies are much better off overseeing their own compliance to regulations
Tue, 03/22/2011 - 08:08
By the time a consent decree comes along—which happens when a firm repeatedly violates current good manufacturing practice (cGMP) requirements and the Food and Drug Administration (FDA) forces it, through legal channels, to make specific changes—it’…
