o White Papers:
01. Failure / Root Cause Investigation and Case Study (two Journal article reprints);
02. 510(k) Submissions (Traditional, Special, Abbreviated;
includes 'traditional' template on DVD or CD-ROM);
03. CAPA;
04. Risk-Based Verification and Validation Planning;
05. Risk-Based Software V&V (in-product, as-product, process, and QM system / Part 11);
06. Risk Management Files / Reports per ISO 14971 / FDA's Q9;
07. Consulting Challenges.
08. Any workshop / webinar topic in Power Point(R) Notes (not PPT presentations) format.
These are a generalized discussion of the subject, regulatory requirements as approriate,
how companies are choosing to implement, common problems, and similar.
Most are 10-20 pp, 8.5 x 11" printed, or xerographics, in a clear front report cover.
Listings subject to change without notice / updated periodically.
$19.95 each (USD; S/H included)