Using examples and case studies, attendees will deepen their understanding of design controls
and find out how to develop procedures that accurately define and document the approach.
001 10 1 (Very low) Table 3: Recommended criterion to assess detection rank Detection Criterion: detection opportunity with Rank current controls Almost Current design controls
can't detect 10 impossible cause/mechanism and its subsequent failure mode or there is no design control
The quality system inspection technique was validated in the sequence: management controls, design controls
, CAPA, and production and process controls.
Weren't these design controls
supposed to prevent this kind of outcome?
Streamlining and simplification of tower design controls
for residential and commercial buildings along the Farley (34th Street) corridor;
The all-nylon design controls
the expansion and shape of the duct in response to heat and pressure.
Short of installing bulletproof barriers and expensive security monitoring systems, there are a number of environmental design controls
that help reduce the likelihood of an event.
for the Medical Device Industry examines successful product development models and superimposes the FDA requirements on them to provide a blueprint for an effective and compliant design control
The SprayStar vehicle and rate control system integrated into the design controls
many machine and solution system functions in an easy-to-read monitor.
Requirements for this standard include design controls
, process controls, special processes, traceability, record retention, and regulatory actions - all critical for the medical device industry.
The CPC called for incorporation of urban design controls
to preserve light and air throughout the complex and its surroundings, make it easier for pedestrians to traverse the site and ensure the quality of the public realm.
Under the proposal, FDA would add design controls
to the Good Manufacturing Practice (GMP) regulation.