GlobalCompliancePanel, a leading regulatory and compliance continuing education training provider, will organize a webinar on the topic, “Calibration and Qualification in Analytical Laboratories”, on June 10. Dr. Ludwig Huber, Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies, will be the Speaker at this session. Description: Laboratory equipment should be calibrated and/or qualified to demonstrate suitability for the intended use. One of the prime reasons for this is that 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 on it, it is a frequently cited deviation in FDA inspectional observations and Warning Letters. Companies are unsure on what exactly to qualify, test and document. This webinar will provide a proper understanding of how to calibrate and qualify laboratory equipment to demonstrate suitability for the intended use. For easy implementation, attendees will receive: • 4 SOPs o User Requirement Specifications (URS) for analytical equipment o Change control for analytical equipment o Qualification of equipment o Allocating Analytical Instruments to USP <1058> Categories • 20+ Examples for Instrument OQ Testing The speaker will cover the following areas at this session: o Operational lab equipment requirements for calibration and qualification o Most common inspection problems o USP Chapter <1058>: Analytical Instrument Qualification o Development of an effective equipment qualification master plan o Calibration/qualification phases: design qualification, installation qualification, operational qualification, performance qualification o Allocating equipment to qualification categories A, B and C o Qualification and documentation requirements for each category o Going through the category example list o Approach for existing systems o Approach for automated systems (including firmware/computer systems) o Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade) o Documentation requirements ----------------------------------------------------------------------------------------------------------------- When: June 10, 10:00 AM PDT | 01:00 PM EDT ----------------------------------------------------------------------------------------------------------------- By whom: Ludwig Huber, Ph.D., is Director of Labcompliance and Chief Advisor for global FDA compliance at Agilent Technologies. Ludwig is the editor of Labcompliance, the global on-line resource for validation and compliance issues for laboratories. He is the author of many books, including Validation and Qualification in Analytical Laboratories and Validation of Computerized Analytical and Networked Systems. He also has more than 100 literature publications and conducts online tutorials regularly. His works speak of his erudition and deep understanding of everything that goes into FDA compliance. That Dr. Huber is a renowned expert on not only the FDA but also other regulatory bodies is evident from the fact that he has been Chief Advisor on Global ISO 17025 and FDA Compliance. ----------------------------------------------------------------------------------------------------------------- For whom: This webinar will benefit o QA Managers and Personnel o Analysts and lab Managers o Analysts o QA Managers and Personnel o Regulatory affairs o Training Departments o Documentation department o Consultant ---------------------------------------------------------------------------------------------------------------- Duration: 75 minutes ----------------------------------------------------------------------------------------------------------------- To enroll for this webinar, contact This email address is being protected from spambots. You need JavaScript enabled to view it. Ph: 800-447-9407 Fax: 302-288-6884

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