RE: course reviews

From: Ritter, Nadine (NRitter@bioreliance.com)
Date: Sun Oct 15 2000 - 20:02:52 EDT


Deanna - There are several good symposia on method validation offered
routinely around the country, some for-profit and others by vendors. I
recommend that you check out BioPharm, a free publication that lists courses
and seminars in each issue. You can check their website for information on
obtaining a subscription.

While the for-profit venues are considerably more expensive, they typically
feature leaders in the field of biotechnology product development, method
validation and regulatory affairs as the speakers. I have been to some of
the vendor-presented seminars with mixed results, although I have to admit I
haven't been to any in the last 2 yrs or so. Perhaps they have improved the
content as the field has matured.

I would also strongly urge anyone interested in the details of validation
studies to get a copy of the International Conference of Harmonization
Guidelines on Method Validation. This is available through links via the
FDA website. I also recommend the USP chapter on Method Validation, which
has a heavy focus on chromatography. This is available in the United States
Pharmacopeia/National Formulary, which must be purchased or viewed in a
library. I don't believe you can access the chapters for free on line.
Maybe some other ABRF'r knows?

BTW: I would recommend the free subscription to BioPharm for anyone who is
engaged in, or seeking to enter, the field of biotechnology product
development. It helped me in making the transition from academic R&D to the
biopharmaceutical industry by presenting articles on key topics and defining
the 'jargon' of the field. Now I read it routinely to keep abreast of new
developments.

Nadine Ritter
BioReliance

-----Original Message-----
From: Deanna Wiebe
To: Recipients of ABRF List
Sent: 10/13/00 10:09 AM
Subject: course reviews

Hello all,

I have a colleague who posed the following question to me, and I thought
I'd pass it along to see if anyone in ABRF has any comments, on the HPLC
validation course offered by this company or suggestions of other good
validation courses.

Thanks!
Deanna

<<I'd like to know if anyone out there has taken any courses (or
specifically, the HPLC method validation course) from LC Resources (
http://www.lcresources.com/ <http://www.lcresources.com/> ). It looks
like a really good course, but it would be nice to have some feedback
from someone who has taken it before.>>

------------------------------------
Deanna Wiebe
Cangene Corporation
26 Henlow Bay
Winnipegİ MBİ R3Y 1G4
ph. (204) 275-4348
fax (204) 989-6879
dwiebe@cangene.com



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