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Part 11 Handbooks - Mix and Match Parts!
ADD CFRs, Guidances, Manuals or even include
your own content !
- Call for details
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Electronic Systems
Master Reference Guide -- $11.90 ea. |
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Part 11 with Scope and Application -- $3.20
ea. |
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210/211 - with Part 11
Electronic Systems -- $6.90 ea. |
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Part 11 & Parts 210/211 - with
210/211 Keyword Index -- $7.90 ea. |
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Cosmetic GMPs – 11,
210/211, 700, 701 & ‘Is it a Soap or a Drug? |
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Parts 11, 210/211
& 820
Elect. Rcds, Drug GMPs QSR - $7.90 ea. |
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GMP Standard Combo - Parts 11, 210/211, 820
& ICH Q7 $9.90 ea. |
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Multi - US GMP - Parts 11, 58, 210/211,
600, 601, 610 & 820 $9.90 ea. |
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EU GMP
1-9, US GMP 11, 210/211, 820 & ICH Q7, Q8, Q9 & Q10 $15.90 ea. |
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US-EU-Japanese GMP Handbook |
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GMP Master with PAT Guidance |
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GMP Auditor’s Basic Handbook |
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Blood-QSR GMPs Parts 11,
210/211, 606, 820 -- $9.90 ea. |
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GMP2 - 11, 58,
210/211, 820 & ICH E6 |
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Spanish Parts 11, 210/211 & 820 - $7.90
ea.
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Add English $14.95* |
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Spanish Parts 11 & 210/211 – $6.90 ea.
-
Add English $12.90* |
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GXP Academy for On-Site Part 11 Training $6,995
(2 Day all Inclusive!) 866-GXPNews |
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Electronic Systems
Master Reference
Guide
$11.90 each
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The Electronic Systems Master Handbook is a
complete reference library for IT and QA
Professionals. This handbook comes in a easy
to carry 4.5" x 7.5" pocket size booklet for
quick access to standards and references.
Includes: |
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US FDA Title 21 CFR
Parts and Guidance References
- Part 11 - Electronic Records
- Scope and Application 2003
- Computerized Systems Used In
Clinical Investigations 2007
European Union (EU) Annexes
- Annex 11 - Computerized
Systems
- Annex 15 - Qualification and
Validation
Includes: The Auditing Group
Part 11 Check List for Computerized Systems
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