Responding to FDA 483 Observations, Part 1Analyzing the inspection results and committing to action
Tue, 11/04/2014 - 12:47
This three-part series will discuss how to respond to the U.S. Food and Drug Administration’s Form 483 (FDA 483), which is issued at the conclusion of an inspection to document potential violations to the Federal Food, Drug, and Cosmetic Act. We’ll… If You Need a Burning Platform to Justify Change...You must really like firefighting
Tue, 10/07/2014 - 13:34
Oftentimes pharma has a split personality. One personality loathes firefighting, and the other needs a burning platform to justify doing anything that requires spending money.
Go figure.
This becomes evident in our industry when some companies can… Essentials for Sustaining an Operational Pharmaceutical Quality System The quality management triad
Wed, 08/13/2014 - 10:15
After nearly 20 years helping the biopharmaceutical industry to regulatory enforcement by implementing an operational and sustainable quality management system, I have come to the conclusion—at the most fundamental level—that there are three… Got CAPA Backlogs? Five underlying causes
Tue, 04/29/2014 - 09:56
You would think that the corrective and preventive action (CAPA) system would be a business enabler—a disciplined approach to permanently resolving problems once and for all. Unfortunately, the way most CAPA systems are designed and used, it is more… Ten Quality System Design AttributesCriteria for an operational and sustainable pharma quality system
Wed, 03/26/2014 - 16:25
There are many instances when a pharmaceutical quality management system (QMS) must be improved in part or as a whole. In some cases improvements are made in response to regulatory inspection observations. In other cases they are made when new… Five Obstacles to Managing a Pharmaceutical Quality System, Part 3Inadequate management review of quality management system performance
Tue, 08/27/2013 - 17:05
Editor’s note: This is the third in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
In part one of… Five Obstacles to Managing a Pharmaceutical Quality System, Part 2Disconnect between the quality control unit and the operation
Tue, 08/06/2013 - 15:20
Editor’s note: This is the second in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
In part one of… Five Obstacles to Managing a Pharmaceutical Quality System, Part 1Disconnect between cGMPs and the business
Wed, 07/24/2013 - 09:41
Editor's note: This is the first in a five-part series exploring issues that affect management’s ability to detect the warning signals of current good manufacturing practice (cGMP) compliance problems in the pharmaceutical industry.
Compliance to… A Tale of Two Deviations From two companies worlds apart in organizational culture
Thu, 05/03/2012 - 12:13
It stands to reason that pharmaceutical companies in compliance trouble also have problems with their deviation management and corrective and preventive action (CAPA) systems. After all, maintaining a good compliance profile as well as an efficient… Seven Success Criteria for Hiring (and Working with) a GMP Consultant You cannot subcontract your problems
Mon, 04/16/2012 - 10:38
The high layoff numbers in the pharmaceutical industry and poor job prospects in a weak economy have flooded the market with would-be consultants to pharma companies that need extra help. Here are my suggestions for hiring and working with an…
