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Causes and prevention: What can we learn from the mistakes of others?
May 4, 2012
By: Martin Lush
NSF-DBA
With Warning Letters and other regulatory action hitting an all time high let’s take time to reflect and ask “What can we learn from the mistakes of others?” In preparation for this article I canvassed the opinion of some learned friends and colleagues within NSF-DBA and, importantly, some senior managers still at the industry coal face. This illustrious group has more than 260 years’ combined pharma experience, with the scars to prove it. Some have been on the end of Warning Letters and other severe regulatory action, all keen to share their experience. As one of them put it, “The moment that letter arrives nothing gets quicker, easier or cheaper. Nothing.” Although these 10 ‘Causal Factors’ are not an exhaustive list, your probability of severe regulatory action will be greatly reduced if you give serious consideration to the ‘Learning Points’. So, with their collective minds focused on causes and prevention, this is what they had to say! Causal Factor: Mergers, Murders and Takeovers Glance down the list of companies in strife and you see a few familiar household names. Most have one thing in common; during the last several years they either acquired or were taken over by someone else. Many of you reading this will know how this feels and what follows. The uncertainty, fear, confusion, complexity and chaos as sites are closed, departments streamlined and systems ‘merged.’ With everyone’s attention focused elsewhere, it’s easy to take your eye off the quality and compliance ball. Attention focuses on the next mortgage payment, rather than process improvement. Change of this magnitude is not only disruptive but incredibly expensive and the accountants want to balance the books sooner rather than later. After all, share price has to be protected and investors placated. Someone has to pay! This payment usually comes in the form of fairly immediate cutbacks, streamlining and efficiency improvements that all tend to boil down to one maxim: Do more with less. Learning Points Change of this magnitude is always complex, stressful and risky. Although we can’t really do this subject justice in one brief article, our industry stalwarts advise:
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