When: |
30 Sep through 30 Sep 2020 | |
Where: |
Online Event | | |
Website URL: |
https://www.complianceonline.com/process-mapping-for-risk-based-p-pc-using-lean-six-sigma-and-haccp-webinar-training-700817-prdw?channel=brownwalker | |
Sponsoring organization: |
Compliance Online | |
Categories: |
Business - Other |
Keywords:
Event description:
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, toget...
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Posting date:
09 August 2020 | 194 views
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