Q: I’m dealing with a design contract house responsible for product design of a medical device. They are responsible for all of the documentation needed for design control, etc. If we produce the first 100 units via the contract house, those units will be…
Tag Archive for design transfer
Re-Audits: When and Why Should You Conduct Them?
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Q: What is industry practice — or more importantly, FDA’s viewpoint — regarding re-audits? Do we need defined and documented criteria for when to conduct re-audits? If so, what would such criteria include? A: My experience is that industry rarely does what is…
Design Validation, Design Transfer or Process Validation: Which Comes First?
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Q: We are currently re-writing our design control procedure and keep reaching a sticking point regarding the order of occurrence of design validation, design transfer and process validation. It’s my understanding that process validation should occur after design validation and design…
Design Transfer: How Can You Demonstrate Successful Transfer to Manufacturing?
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Q: I have a question about FDA expectations for design transfer. What can we use as evidence to demonstrate we’ve met the QSR requirement that “design is correctly transferred”? Is a verification report for each work instruction enough? A: Design transfer is…
Design Validation, Design Transfer or Process Validation: Which Comes First?
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Q: We are currently re-writing our design control procedure and keep reaching a sticking point regarding the order of occurrence of design validation, design transfer and process validation. It’s my understanding that process validation should occur after design validation and design…
How to Audit Suppliers for Design Control Compliance
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Q: When we audit suppliers for design control, what’s the best approach for doing the audits? And what main documents should we review? A: To audit a third-party design facility, first ensure it’s registered with the FDA and has a Quality…