Tag Archive for 483 Observation

Guidelines for Making Quality System Changes

Q: I think we understand what’s required for changes to a product design or manufacturing process. But when it comes to making changes to a quality system procedure or work instruction, we’re not clear on what’s needed prior to implementing such quality…


How Often Should You Conduct Internal Audits?

Q: I’ve found conflicting information on how frequently to perform internal audits. The ISO standards and the Quality System Regulation don’t have any frequency recommendations, but FDA’s Quality System Inspection Technique (QSIT) Guide recommends every 12 months. I’ve been in…


Managing FDA Inspections: Do’s and Don’ts

When FDA is at your site, follow these suggestions for managing FDA inspections — offered by the EduQuest staff, many of whom are former FDA expert field investigators: Have a defined location for investigators to work. Always accompany them through your facility.…