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© 2020 MJH Life Sciences and Spectroscopy Online. All rights reserved.
© 2020 MJH Life Sciences™ and Spectroscopy Online. All rights reserved.
R.D. McDowall is principal of McDowall Consulting and director of R.D. McDowall Limited, and "Questions of Quality" column editor for LCGC Europe, Spectroscopy's sister magazine.
December 01, 2015
Some parts of the FDA’s new draft guidance for Development and Submission of NIR Analytical Procedures are reviewed and critiqued. What’s in it for spectroscopists?
November 01, 2015
A current hot topic in regulated GXP laboratories is data integrity. Recently, the UK regulator issued an industry guidance on this subject that requires the establishment of a data governance system, part of which is data integrity training. Easy to say, but how do you do it?
September 01, 2015
A proposed update to USP on Analytical Instrument Qualification (AIQ) has been issued for public comment. Here, we identify the changes that are proposed and their impact on the AIQ process of analytical instruments and laboratory computerized systems.
April 01, 2015
This month we discuss ISO Guide 80, "Guidance for the In-House Preparation of Quality Control Materials." This practical guide is worth reading, and its contents should be compared with your current working practices. In addition, we look at options for the preparation of working solutions from stock solutions to see the errors that could occur.