This webinar will discuss the basic principles of P&PC, specifically as required by the FDA. Also attendees will learn the ISO 13485 and risk analysis/management requirements to evaluate the chief areas of an FDA CGMP compliance inspection/audit to locate areas for implementation and improvement in P&PC.
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.
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
Speaker
John E LincolnCourse Provider
John E Lincoln,
