Palo Alto, CA (PRWEB) July 27, 2013
ComplianceOnline, the leading governance, risk and compliance advisory network with over 500 experts in various regulatory subjects, today announced a seminar on Analytical Instrument Qualification and System validation. The two day long seminar led by lab compliance expert Dr. Ludwig Huber will be held on August 29 and 30, 2013 in Cambridge, MA.
This two day seminar will explain FDA regulatory requirements for analytical instrument qualification and system validation and will provide tools needed to develop and implement effective instrument qualification and system validation process to avoid FDA warning letters.
For more information or to register for the seminar, please click here.
Seminar instructor Dr. Ludwig Huber is an expert for FDA and equivalent international compliance and for ISO/IEC 17025 laboratory accreditation. He served as a team member of PDA's task forces "21 CFR Part 11," of US-FDA internal documents, and of the GAMP® special interest group on laboratory equipment. In addition, he was awarded as Presenter of the Year of the Institute for Validation and Technology.
During the two day interactive seminar, Dr. Huber will focus on instrument qualification and system validation processes. This seminar will provide attendees the regulatory background and guide them through the complete process from planning and writing requirement specifications to vendor assessment, installation and operational qualification and ongoing testing during routine use. Dr. Huber will explain how to avoid and/or respond to FDA inspectional observations and warning letters. Attendees will receive a large variety of tools such as SOPs, validation examples and checklists that can be used to easily implement
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