21 CFR 11 Services offered by McDowall Consulting.
This needs a link to computerised system validation and vice versa
The 21 CFR 11 regulation has been effective since 20th August 1997 but it is only since 1999 that the FDA has begun to enforce it under the framework of the Compliance Policy Guide.
Bob McDowall has been active in publishing articles on the subject in several journals such as LC-GC, American Pharmaceutical Review and Spectroscopy; examples of his articles can be downloaded from this site as well as the library at www.21cfrpart11.com.
PDF files to link with on the site
McDowall Consulting offers services to clients in several areas:
Companies wishing to sell 21 CFR 11 compliant computerised analytical systems or software to the pharmaceutical industry can use the services of McDowall Consulting in the following ways:
|Day||Training Course Contents|
AM: Introduction to 21 CFR 11
PM: Practical Implementation of 21 CFR 11
AM: Evaluation of a System – 1
PM: Developing Procedural Controls and How to Handle Technical Controls
Evaluation of a System – 2
Evaluation of a System – 3
Review of the Course and Way Forward