Validating environmental scan

Identifying design problems, and solving them as early in the design cycle as possible, is the key to keeping projects on time and within budget.

Too often, product design and performance problems are not detected until late in the product development cycle — when the product is ready to be shipped.

RESULTS: Two hundred twenty-three residents completed the 43-item draft SPEED.METHODS: Stepwise, we developed a screening instrument, using existing instruments to assess educational environment quality and adopting a theoretical framework that defines three educational environment domains: content, atmosphere and organization.First, items from relevant existing instruments were collected and, after deleting duplicates and items not specifically addressing educational environment, grouped into the three domains.In the last year or so the FDA and the EMA have issued new guidance/ draft guidance on "Process Validation".These align process validation activities with a product lifecycle concept and the International Conference on Harmonisation (ICH) guidances for industry, Q8(R2) Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System.

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