For additional products / services, see  "SOPS".

Our promise to you: Satisfaction Guaranteed

-- Exchange, apply credit to another purchase,and/or return,

and your money refunded or account credited, if product(s) not as

represented, or if not completely satisfied.


If you don't see a title above that you need CONTACT US, and we may have it or can create it.

$275.95 (USD) each


Webinar, 1 attendee

o  Pocket Guide:  

   Quality System Regulation (The GMPs), 21 CFR Part 820.  

$5.95 (USD; S/H included)

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)

White Paper Title

o  Workbooks:  

     Available workbooks on any subject listed under "Seminars / Workshops".

     Contain Power Point Notes, draft SOPs, guidance documents and/or similar from workshop.

     Indexed / tabbed and in a loose-leaf, 3-ring binder.

List subject to change without notice / updated periodically.

$39.95 (USD; S/H included).

Workbook Title

Generic CGMP audit templates are available for $495.00 USD each at this site.

Which CGMP desired


Last updated 04/13/2023.