Date : Thursday, May 26, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 75 Minutes Price : $245.00
Live Webinar Calibration and Qualification in Analytical Laboratories
Overview: Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use.
Instructor Profile: Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies
Laboratory systems including equipment are amongst key targets of FDA inspections. They are considered high risk systems because they have a high impact on product quality. Despite the fact that equipment calibration and qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters. Companies are unsure on what exactly to qualify test and document.
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4 SOPs ¡ User Requirement Specifications (URS) for analytical equipment ¡ Change control for analytical equipment ¡ Qualification of equipment ¡ Allocating Analytical Instruments to USP <1058> Categories Allocating Analytical Instruments to USP <1058> Categories
Areas Covered in the Session:
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Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. He is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of the books "Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Informa Healthcare. ...more
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Operational lab equipment requirements for calibration and qualification Most common inspection problems USP Chapter <1058>: Analytical Instrument Qualification Development of an effective equipment qualification master plan Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification Allocating equipment to qualification categories A, B and C Qualification and documentation requirements for each category Going through the category example list Approach for existing systems Approach for automated systems (incl. firmware/computer systems) Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade) Documentation requirements
Click here to register for this webinar Who Will Benefit: l l l l l l l l
QA managers and personnel Analysts and lab managers Analysts QA managers and personnel Regulatory affairs Training departments Documentation department Consultans
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