2021 - Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP

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…