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2020 - Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP
Date2020-09-30
Deadline2020-09-20
VenueOnline event, USA - United States 
KeywordsProcess; Mapping; Risk
Topics/Call fo Papers
P&PC and U.S. FDA CGMP / ISO 13485 / 9001 requirements
Tougher FDA Expectations / Requirements
Key elements of P&PC in a regulated industrial environment
Process mapping / flow charting and P&PC
FDA’s HACCP
Lean manufacturing’s role
Basis easy to learn / teach / use six sigma / SPC tools
“Risk-based” per ISO 14971 / ICH Q9
Documentation
Prove / maintain “in statistical control”
Document – lot / batch records, logs, analysis / charts…
Tougher FDA Expectations / Requirements
Key elements of P&PC in a regulated industrial environment
Process mapping / flow charting and P&PC
FDA’s HACCP
Lean manufacturing’s role
Basis easy to learn / teach / use six sigma / SPC tools
“Risk-based” per ISO 14971 / ICH Q9
Documentation
Prove / maintain “in statistical control”
Document – lot / batch records, logs, analysis / charts…
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Last modified: 2020-05-21 17:45:57