Date : Thursday, June 16, 2011 Time : 10:00 AM PDT | 01:00 PM EDT Duration : 75 Minutes Price : $245.00
Live Webinar Understanding and Implementing USP 1058: Analytical Instrument Qualification
Overview: Analytical instruments should be qualified to demonstrate suitability for the intended use. Despite the fact that instrument qualification is nothing new and companies spend a lot of time, it is a frequently cited deviation in FDA inspectional observations and warning letters.
Register Now Instructor Profile: Dr. Ludwig Huber Chief Advisor - Global FDA compliance, Agilent Technologies
Companies are unsure on what exactly to qualify or re-qualify, test and document. The main reason is that unlike for Ludwig Huber, Ph.D., is Director of analytical methods there are no clear standards for Labcompliance and Chief Advisor for equipment qualification. This has changed. The USP has global FDA compliance at Agilent developed a new standard for analytical instrument Technologies. He is the editor of qualification (AIQ). Labcompliance, the global on-line resource for validation and Areas Covered in the Session: compliance issues for laboratories. He is the author of the books l FDA and EU analytical instrument requirements "Validation and Qualification in l Most common inspection problems Analytical Laboratories, and l Terminology, scope and principles of US chapter "Validation of Computerized <1058>. Analytical and Networked Systems", l AIQ and its relation to method validation, system Informa Healthcare. ...more suitability testing and quality control checks l Essential steps for AIQ: DQ, IQ, OQ, PQ Related Products l Purpose and contents of design qualification, ISO 13485 Gap Analysis Toolkit installation qualification, operational qualification, performance qualification ISO 13485 Quality Manual l Allocation of instruments to the three categories A, B Intro to ISO 13485 Presentation and C Materials l Procedures and validation deliverables for the three categories ISO 13485 Internal Auditor Checklist l Recommendations for firmware and software validation more... l Roles and responsibilities: QA, manufacturer, user Your Necessity is our Priority l Approach for automated systems (incl. firmware/computer systems) l Qualification of existing systems l Requalification after equipment changes (move, repair, firmware upgrade, hardware upgrade) l Recommendations for effective implementation Click here to register for this webinar Who Will Benefit: l l l l l l l l l l l l
Laboratory Managers and Staff Analysts QA Managers and Personnel Regulatory Affairs Training Departments Documentation Department Consultants Validation Specialists Regulatory Affairs Training Departments Documentation Department Consultants
It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel
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