Event Date/Time: Sep 30, 2008
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.
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