| Publication | Hyperlink / description |
|---|---|
| Human and Veterinary Drug; cGMP Violations and Trends (PharmaManufacturing, Feb 2009) | Related article: “cGMP Violations: Beware Complacency” (Sept 2007) examines FDA 483 observations and warning letters. Available at: pharmamanufacturing.com — cGMP Violations: Beware Complacency . |
| Computer System Validation: FDA Inspections (Life Science Leader, Mar 2010) | Accessible on Pharmaceutical Online. Discusses preparing for FDA inspections of computer system validation programs. Available at: pharmaceuticalonline.com — Computer System Validation and FDA Inspection . |
| FDA Violations and Industry Trends (Life Science Leader, Jul 2010) | “Trends in FDA Violations” (Jul 6, 2010) reviews common violations, including computer-system validation deficiencies. Available at: lifescienceleader.com — Trends in FDA Violations . |
| Internal Audits (Life Science Leader, Jun 2010) | “Internal Audits for Pharma and Biotech” (Jun 8, 2010) explains the importance of quality audits and references 21 CFR 820. Page (login may be required): lifescienceleader.com — Internal Audits for Pharma and Biotech . |
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