QA/RA Consulting, Auditing & Training
Pharma Process Validation: Where Do We Start? The entire purpose of conducting validation is to build quality, safety, and effectiveness into the finished pharmaceutical, and not to rely on post-production batch testing. To accomplish this, you need to make sure that every process step performs as expected based on quality design, with the ultimate goal […]
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Overview of Medical Device Process Validation: IQ, OQ, and PQ In this article: How the US FDA defines process validationDifference between verification and validation Relationship between design validation and process validationWhich production processes require validation?Basic steps in process validationProcess validation plans and protocols for IQ, OQ, and PQForming your process validation teamIt all starts with […]
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This is the last article of a three-part series on non-product software risk assessment, validation and testing. Download the entire series in one convenient PDF. Part 1: NPS Risk Assessment for Medical Device Manufacturers Part 2: Non-Product Software (NPS) Validation for Medical Device Manufacturers Part 3: This article Theres a lot of preparation involved in […]
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This is the second article of a three-part series on non-product software risk assessment, validation and testing. Download the entire series in one convenient PDF. Part 1: NPS Risk Assessment for Medical Device Manufacturers Part 2: This article Part 3: Writing NPS Protocols and Testing for Medical Device Manufacturers Compiling a comprehensive list of all […]
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