PRODUCT CATALOG

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.

 


Power Point Presentation E-Files (Note: these are slide presentations only; there is no audio):

01. Quality System Regulation (The Device CGMPs), 21 CFR Part 820; or

02. ISO 13485 (Medical Device Quality Management System); or

03. ISO 14971 (Hazard Analysis / Risk Management); or

04. CAPA; or

05. Risk-Based Verification and Validation Planning to Satisfy U.S. FDA and EU ISO Requirements; or

06. Failure Analysis and Root-Cause Analysis; or

07. Software Verification and Validation Planning to Meet U.S. FDA and EU ISO Requirements;or

08. The 510(k) Submission; or

09. Medical Device Changes and the 510(k); or

10. Dietary Supplements CGMPs (21 CFR 111).

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

 

PPT File desired

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.

For specific categories available, go to GMP-AUDITS

Which CGMP desired

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Last updated 02/10/2016.