Download Some Interesting Documents
Here are pdf copies of presentation and regulations more often requested by our clients. Also, a few of our good templates (investigation report, corrective action, preventive action) are available for free downloading
- The Biggest Opportunities of the CAPA System (08-2011)
- ISO 17025:2005 - Quality System for the Analytical Lab. (08-2011)
- 2008 Process Validation Guidelines (DRAFT)
- Amendments to cGMP(21 CFR 210 & 211) effective Dic 2008
- 21 CFR 820 QSR & Preamble
- 21 CFR 210 & 211
- Preamble 21 CFR 210 & 211
- OOS Guidance (2006)
- QSIT Guide
- Combination Product Guidance
- Quality System approach to Pharma cGMP
- Pharmaceutical GMP for the 21st Century: A risk based approach
- Guide To inspection of QC Labs
- Reducing documentation errors with six sigma (artículo de QP)
- Reducing Human Errors (artículo de Quality Progress)
- Quality Basics by Phil Crosby (artículo de Quality Progress)
- ICH Q9 Quality Risk Management
- ICH Q10 Pharmaceutical Quality System DRAFT