Apr 23 | The QA Pharm
It stands to reason that pharmaceutical companies in compliance trouble also have problems with their Deviation Management and Corrective and Preventive Action (CAPA) System(s).
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Apr 16 | Girish Malhotra, PE, President, EPCOT International
The answer is an unequivocal yes but we need some outsiders who can conspire with the insiders who will be the flag bearers within the companies. Outsiders can be the counsels/co-conspirators to the insiders for the coup d'etat.
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Apr 16 | The QA Pharm
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 a good GMP consultant.
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Apr 6
I’ve recently come to the conclusion that there are two kinds of epiphanies – the kind you like to brag about and the kind where you look around and say to yourself, “Am I the last person to figure this out?”
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Mar 23 | Jonnatha Mayberry, Associate Editor
It seems that as humans, we are excellent at “temporary learning”: The art of correcting potentially reckless behavior after some event shakes us up, but then quickly reverting to our careless ways.
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Mar 22
I’m a big fan of those web stories that list 10 things your (insert name of profession) won’t tell you. From waiters to flight attendants to nurses – I’ve read them all – and most of their insights are not pretty.
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Mar 21 | Dr. Jamie Weiss, Senior Consultant, Kepner-Tregoe, Inc.
Seeking and finding correlations – co-occurrences between two or more factors – is a key tool in the root cause analysis arsenal. It can lead you to possible causal factors to investigate.
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Mar 19
I typically use this space for talking about industry issues, offering my views and opinions on recent developments such as recalls and the recent drug shortage crisis. To me, that is just one side of the industry.
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Mar 7 | Girish Malhotra, PE, EPCOT International
During my career I have been involved in process simplification and cost reduction of different chemistries, chemicals and processes. When I am discussing any process, my mind always races to understand its chemistry, manufacturing process and how the cost can be lowered and the profit improved.
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Mar 5 | By John Ager, Consultant and Master Trainer for Kepner-Tregoe (KT)
Which organization is more like yours? FDA regulations will choke our business or compliance audits provide useful insights about what we can improve.
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