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

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…

Who Will Benefit:

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

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

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