Reading

In order to best utilize the Quality Systems Educational Forum: Production and Process Controls, we recommend your read the following online references. Portable Document Format (pdf) files  require Adobe Acrobat Reader to display and print.

Highly Recommended

• Medical Device Quality Systems Manual: A Small Entity Compliance Guide
• FDA CDRH Device Advice: Good Manufacturing Practices (GMP) / Quality System (QS) Regulation
• Guideline on General Principles of Process Validation
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff

Recommended

• 21 CFR 820 – Quality System
• The Good Manufacturing Practice (GMP – Quality System Regulation) Final Rule (Federal Register) and Preamble
• Quality System Inspection Technique (QSIT) Handbook 
• Compliance Program 7382.845 – Inspections of Medical Device Manufacturers

Optional

• Process Validation Guidance for Medical Device Manufacturers, Global Harmonization Task Force
• ISO 9001 Comparison to the Quality System
• Do It By Design: An Introduction to Human Factors in Medical Devices