TY  - ADVS
AU  - Nicholas,Steve
TI  - SOPs as part of the quality system
T2  - SOPs for regulatory applications for the pharmaceutical industry,
PY  - 2013///
CY  - London
PB  - Henry Stewart Talks
KW  - Pharmaceutical industry
KW  - Quality control
KW  - Documentation
KW  - Standards
KW  - Quality assurance
KW  - Drug Industry
KW  - methods
KW  - organization & administration
KW  - Drug industry
KW  - standards
KW  - Guidelines as Topic
KW  - Quality Control
N1  - 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; Access restricted to subscribers
UR  - https://hstalks.com/bs/2569/
UR  - https://hstalks.com/bs/p/738/
ER  -