FDA Guidance: Q9 Quality Risk Management, 6/06
$0.00
June, 2006 CDER and CBER issuance of the ICH Q9 quality risk management document.
Note Annex II section II.4 on how a risk based approach can be applied to computer validation.
| Issuing Body | FDA Guidance Documents |
|---|
You may also like…
-
EMA Reflection Paper on Risk Based Quality Management in Clinical Trials, 11/13
This 2013 EMA Reflection Paper supports GCP principles by recommending a systematic, risk-based approach to quality management of clinical trials.
$0.00 Add to cart -
FDA Draft Guidance: Presenting Risk Information in Prescription Drug and Medical Device Promotion, 5/09
In May 2009, the FDA published this draft guidance. Web site designers and builders will want to review section III.C.2., Non-Print Promotion, for specific design requirements.
$0.00 Add to cart -
FDA Pharmaceutical CGMPs for the 21st Century – A Risk Based Approach, 9/04
September, 2004 report on the FDA’s modernization programs. Contains an update on 21 CFR Part 11 approach.
$0.00 Add to cart
