Process Analytical Technology (PAT) – A Practical Approach
April 21, 2015 - Fremont CA USCompliance4all
support@compliance4All.com
Phone:8004479407
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Overview: PAT is what the pharmaceutical industry has phrased as their innovation; however the balances of the American manufacturing industries have been using since the 1970s. PAT is the use of process control systems to control pressure, temperature, level, flow rate, and other primary variables that control the quality, and cost of our products. This process requires direct measurement of the quality variables or inferential measurement of highly correlated variables to control final critical quality parameters. We use those primary measurements (dependant variables) within a process control system to manipulate the variables to achieve the optimal quality or a final quality end point. In some cases our quality control will deliver the same quality currently achieved, but with a shorter batch time, reduced costs (energy, solvents, gas purges, etc.) PAT uses process control and measurement technology to provide a more automated, less operator dependant, less operator interactive, more precise, and a less costly production. Why should you Attend: Both the FDA and the EU via their guidance documents and the ICH Compliance series suggest and recommend investigation and use of PAT. Too much of our manufacturing processes and practices have no technical basis and are built on inefficient and historical folklore, even though our regulatory submissions give us the flexibility PAT highlights the need for process understanding, the use of process analytical tools and using computer based process control to determine the product outcome. Areas Covered in the Session: Introduction of PAT and what it is and isn’t Identification of Opportunities within your processes Justification for PAT project and expectations of the result The parts of the project The need to use or develop a mathematical model of the process Model forms and modeling tools How to develop the models needed Process control application General examples Summary Who Will Benefit: Engineering Operations Quality and Validation functions Speaker Profile Mr. Bozenhardt has 37 years of experience in pharmaceutical, biotechnology and medical device manufacturing, engineering and compliance. Mr. Bozenhardt’s expertise is in a wide spectrum of processes, engineering, compliance and computer systems and related technologies. Compliance4All Adam Fleaming Phone: +1-800-447-9407 Event Link: http://bit.ly/1KbkLlL support@compliance4all.com www.compliance4all.com