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

  • ID: 5519540
  • Webinar
  • January 2022
  • Region: Global
  • 60 Minutes
  • Compliance Online

Why Should You Attend:


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
  • 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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  • Senior and middle management.
  • Quality Assurance/ Quality Control
  • Regulatory Affairs
  • R&D
  • Engineering
  • Operations
  • Production / Manufacturing
  • Staff and Line personnel
  • Sales and Marketing
Note: Product cover images may vary from those shown