Process Mapping - Risk-Based P&PC (700817LIVE)

Venue: Online

Location: Palo Alto, California, United States

Event Date/Time: Sep 30, 2008
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Description

Description
U.S. FDA Warning Letters and recent high-profile recalls indicate major cGMP, process, verification and validation deficiencies in many companies.
A major failing is the lack of proper controls on the production process. The U.S. FDA's Production and Process Controls (P&PC, 21 CFR 820.70) require that production processes by controlled and monitored to ensure product conforms to specifications. Lean six-sigma principles have made "process mapping" a key element in identifying the major inputs, processes, and outputs acting upon a product. The FDA's HACCP (Hazard Awareness of Critical Control Points) is a complementary methodology to identifying, controlling and monitoring those "critical few" steps in the production process that effect the quality, reliability and safety/efficacy of the resulting product.

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Areas Covered in the seminar: * Enhanced application from an old friend. * Process Map Types; advantages / disadvantages. * Depicting inputs. * Lines and nodes of activity. * Design to allow detailed workflow analysis. * Optimization of workflow. * HACCP and critical-to-quality analysis. * How to incorporate Risk Management Tools (per ISO 14971:2007)? * Team analysis and management review. * Some "real world" test case examples. * HACCP (Hazard Awareness of Critical Control Points), and its implementation and use under P&PC. * Risk Analysis and Management and P&PC. * Verification and validation's role. * Monitoring tools, e.g., SPC (Statistical Process Control)/ 6 sigma; Toyota Production System methodologies. * Lean manufacturing and P&PC. Who will benefit: * Senior Manegemrnt * Project Leaders * Regulatory Affairs * Quality systems personnel * R&D, product and manufacturing engineering staff. * All charged with new product / pilot development, regulatory submissions, initiating / overseeing company-wide software / V&V planning, using an ISO 14971:2007-based risk-justified approach. * CAPA and P&PC personnel desiring to minimize post-production / life cycle and other costly problems. * Quality Assurance Engineer * Trainers