SOPs as part of the quality system [electronic resource] / Steve Nicholas.
Material type:
FilmSeries: Henry Stewart talksBiomedical & life sciences collection. SOPs for regulatory applications for the pharmaceutical industry: Publisher: London : Henry Stewart Talks, 2013Description: 1 online resource (1 streaming video file (18 min.) : color, sound)Other title: Standard operating procedures as part of the quality systemSubject(s): Pharmaceutical industry -- Quality control -- Documentation | Pharmaceutical industry -- Quality control -- Standards | Quality assurance | Quality control -- Standards | Documentation | Drug Industry -- methods | Drug Industry -- organization & administration | Drug industry -- standards | Guidelines as Topic | Quality Control -- methodsOnline resources: Click here to access online | Series Animated audio-visual presentation with synchronized narration.
Title from title frames.
Contents: The need for SOPs -- Requirements of SOPs -- Quality related terminology -- Process capability -- SOP as a trainee manual -- The large volume of a paper-based system -- Information on demand -- FDA deficiencies -- A traditional vs. a process based approach -- Uniformity of performance -- SOP in a traditional quality system -- SOP developed by function -- Independent quality department -- Modern, robust quality management system -- DMAIC approach to continual improvement -- Process mapping -- Identification of gaps -- Incorporation into the workflow -- Mistake proofing (Poka yoke) -- FlyBy airlines and the online booking system example -- Flow of the processes -- Documentation of key processes -- SOP software -- SOPs and the new generation.
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Mode of access: World Wide Web.