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Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP - 2022 Webinar -

DUBLIN--(BUSINESS WIRE)--The "Process Mapping for Risk-Based P&PC Using Lean Six Sigma and HACCP" webinar has been added to's offering.

There is an on-going major shift in the emphasis of U.S. FDA CGMP compliance emphasis. The 2011 Pharma Process Validation Guidance Document emphasizes "P&PC" to ensure "homogeneity within batch" and "consistency between batches", basic Dr. Deming, et al.

Such changes in regulatory focus should have a major impact on individual compliance objectives, efforts and measurements of success. Using P&PC, lean, six sigma/SPC, together with process mapping/flow charting and HACCP, will yield major business benefits as well: Reduced waste/scrap, early warning of process shifts before non-conforming product is manufactured, increase efficiencies, minimal need for re-validations of equipment and/or process, and opportunities for improvement in quality, through-put. A case of regulatory/business "win-win".

P&PC systems, metrics, and information/analysis, combined lean principles, and six sigma/SPC tools, and the FDA's QSIT for medical devices and pharmaceutical requirements, together provide an effective, proactive and aggressive/robust methodology to maintain a production process in a "state of statistical control", and in CGMP compliance for any regulated industry. Software, data integrity, and cybersecurity issues are considered. Such a system greatly reduces the need for equipment/process re-verification/-qualification/-validation.

Areas Covered in the Webinar:

  • 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
  • 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.

Who Should Attend:

  • Senior and middle management.
  • Quality Assurance/ Quality Control
  • Regulatory Affairs
  • R&D
  • Engineering
  • Operations
  • Production / Manufacturing
  • Staff and Line personnel
  • Sales and Marketing

For more information about this webinar visit

Laura Wood, Senior Press Manager
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

Editor Details

  • Company:
    • Businesswire
Last Updated: 04-Jul-2022