"Educating about FDA requirements", is somewhat company dependent. And it is an ongoing process.
As a Pharma statistician, you can always contact someone in regulatory or QA to find out particular regulations /company SOP's that apply in one's area.
Generally, you should read the ICH guidelines, and any of the various statistics related guidelines that FDA issues.
For example if you are working on adaptive trials, you would read the FDA guideline on adaptive trials.
When I work with the Development side of the company, I'm required to read the companies - Statistics, some Data Management and some Clinical /Safety reporting SOPs' in the first week or two after starting. And often there are short quizzes on the SOP. You should always keep a record of what you read/tested on, even if the company didn't require you to keep a record.
One company I worked for, required one to record "training", for example if you went to a statistics short course.
FDA is one of several regulatory agencies, and there are guidelines and regulation for countries outside the U.S.
CLISA as far as I can tell, is not part of FDA per se.
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Chris Barker, Ph.D.
President - San Francisco Bay Area Chapter of the American Statistical Association
www,barkerstats.com
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Original Message:
Sent: 09-06-2011 15:05
From: Moni Neradilek
Subject: Accreditation
I would be interested to hear about the FDA aspect of one's credentials and pertinent experience, especially how statistical consultants educate themselves in regards to the FDA regulations. My experience has been that often the statistical concepts and methods utilized in the regulations are "no rocket science" statistically but the situation requires one to find and study some very detailed guideline documents. For example, one of my recent clients was involved with the FDA and required help with certain CLSI (Clinical and Laboratory Standards Institute) standards. So my question is: do people educate themselves for the FDA-related work through a formal learning (e.g. courses in FDA guidelines and regulations) or through self-study? I would be interested to know what resources people use. Also, I presume that the guidelines and regulations change over time and one needs to keep up.
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Moni Neradilek
Statistical Consultant
The Mountain-Whisper Light Statistics
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Original Message:
Sent: 09-06-2011 14:25
From: Larry Muenz
Subject: Accreditation
In 25 years of full-time biostatistical consulting, no potential client (denominator = 100+) has ever asked me about accreditation, or even used the word. There's no evidence that they know this exists, or care about it. They care a little about academic credentials, but primarily about pertinent experience, often with FDA-regulated products and with the FDA itself. Of course, accreditation may increase in importance, but that hasn't happened yet. (Or, it may be more important in non-medical areas of statistics.) At this point, in the biomedical arena, only other statisticians would care, and that is of some importance, but mainly for pride, not for getting work.
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Larry Muenz
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